Heart Health News Archive

Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction
Source: Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction, FDA Press Release, April 30, 2008.

Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc.

The consent decree prohibits the manufacture, distribution, and export of specified AEDs at or from Physio-Control's facility in Redmond, Wash., until the devices and facilities have been shown to be in compliance with the Food and Drug Administration's (FDA) current Good Manufacturing Practice (cGMP) requirements, as set forth in the Quality System regulation for devices.

Under terms of the decree, Physio-Control and Medtronic agreed to take necessary measures to ensure that AEDs manufactured and designed at the Redmond facility comply with cGMP requirements and FDA regulations for reporting device corrections and removals.

Read full release

Coronary Artery Plaque Imaging Device Cleared by FDA
Source: Coronary Artery Plaque Imaging Device Cleared by FDA, FDA Press Release, April 29, 2008.

The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.

The InfraReDx LipiScan NIR Catheter Imaging System uses infrared imaging to detect lipid core-containing plaques of interest and assess a patient's coronary artery lipid core burden index. The device works by placing a catheter equipped with a fiber-optic laser light into the artery. The device shines the near infrared light delivered through the blood to the artery wall, and measures the light reflected back from the artery wall, a technique called spectroscopy. The reflected wavelengths vary depending on how much fat and other substances are in the plaque in the illuminated portion of the wall.

The device is cleared for use by physicians who are evaluating patients with symptoms of coronary heart disease during a heart test known as cardiac angiography, to help in detection of plaques that have lipid (fatty) cores.

Read full release

Recall of all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP) by Actavis Totowa
Source: Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP) as precaution, Firm Press Release, April 25, 2008.

Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.

The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.

Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health care providers.

Read full release

FDA Approves First Compact Heart Assist Device
Source: FDA Approves First Compact Heart Assist Device, FDA Press Release, April 21, 2008.

The U.S. Food and Drug Administration approved a heart assist device with a novel design where the device uses a continuous flow pump that constantly moves blood with a single moving part. This allows the device to be slimmed down to a mere three inches in length and a weight of approximately one pound.

Heart assist devices are surgically implanted mechanical pumps that help the heart's ventricle do its work of pumping blood to the rest of the body. Previous models were too large to be placed in the upper abdomen of some women and small-sized men.

The product's manufacturer, Thoratec Corporation of Pleasanton, Calif., is required to conduct a post-approval study to further evaluate the HeartMate II's performance during commercialization.

Read full release

Recall of Twelve Dietary Supplements Because of Possible Health Risk Associated with Ephedra, Aristolochic Acid and Human Placenta
Source: Herbal Science International, Inc. Recalls Twelve Dietary Herbal Supplements Nationwide Because of Possible Health Risk Associated with Ephedra, Aristolochic Acid and Human Placenta, Firm Press Release, April 10, 2008.

Herbal Science International, Inc. is recalling twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers.

The company is recalling products under the following brands: Wu Yao Shun Qi San, Qing Bi Tang (Nasal Cleanser), Zhong Fong Huo Luo Wan (Stroke Revito Formula), Xiao Qing Long Tang (Little Green Dragon), Ding Chuan Tang, Xiao Xu Ming Tang, Feng Shi Zhi Tong Wan (Joint Relief), Guo Min Bi Yan Wan, Fang Feng Tong Sheng San, Tou Tong San (Headache Formula), Du Huo Ji Sheng Tang (Du Huo Joint Relief) and Seng Jong Tzu Tong Tan.

FDA has regarded dietary supplements containing ephedra as potential health hazards because this botanical contains ephedrine alkaloids. Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects on the heart. Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. This chemical can cause serious kidney damage and the use of products that contain aristolochic acid has been associated with several occurrences of kidney failure.

All lots are covered in this recall action. Consumers who have purchased these products should immediately discontinue their use and return them to the place of purchase for a full refund.

Read full release

Automated External Defibrillators and CPR Are Equally Helpful for Sudden Cardiac Arrest in the Home
Source: Automated External Defibrillators and CPR Are Equally Helpful for Sudden Cardiac Arrest in the Home – Study Finds AEDs Underused at Home, NHLBI Press Release, April 1, 2008.

The first study to explore the use of automated external defibrillator (AEDs) in the home has found that although the safe and easy-to-use devices are effective for certain types of cardiac arrest, they were underused.

Researchers followed heart attack patients at moderate risk of sudden cardiac arrest who had a spouse or other live-in companion who agreed to take conventional steps to respond to a sudden cardiac arrest -- calling emergency medical services (EMS) and performing cardiopulmonary resuscitation (CPR) – with households that were asked to use an AED before taking conventional life-saving steps. After an average of just over three years of follow-up, researchers found that survival rates were about the same between those who had an AED in the home and those who did not.

Read full release

FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries
Source: FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries, FDA Press Release, March 26, 2008.

U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach announced that the agency has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, devices used to treat blocked heart arteries.

FDA and the clinical community have been closely monitoring these devices, including concerns over clot formation in some patients several years after implantation. The draft guidelines issued —called an FDA guidance document—outline the agency's recommendations for pre-market clinical evaluation and post-market studies, which may provide data to better address this and other potential safety concerns.

This draft guidance discusses the development pathway for new drug-eluting stents and provides recommendations on information necessary for a complete marketing submission. It also provides guidance on assessing the toxicity of the drug used to coat the stent, both on its own and as part of the complete product.

Read Draft Guidance

Read full release

FDA Warns Consumers Not to Use “Blue Steel” and “Hero” Products
Source: FDA Warns Consumers Not to Use “Blue Steel” and “Hero” Products - Products are illegal drugs and pose serious health risks, FDA Press Release, March 25, 2008.

The U.S. Food and Drug Administration is advising consumers not to purchase or use "Blue Steel" or "Hero" products marketed as dietary supplements throughout the United States because they are considered unapproved drugs and have not been proven to be safe or effective. These products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level.

Blue Steel and Hero products do not qualify as dietary supplements because they contain undeclared and unapproved substances. The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels.

The FDA advises consumers who have used either of these products to discontinue use and consult their health care professional if they have experienced any adverse events that they feel are related to the use of these products.

Read full release

Recall of Heparin API Prompts Recall of Heparin Solutions
Source: B. Braun’s Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions, Firm Press Release, March 21, 2008.

B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product (FP) lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada.

This product recall was initiated due to a notification received from the supplier, Scientific Protein Laboratories (SPL), disclosing that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient acquired by B. Braun Medical Inc. has a heparin-like contaminant. To date, B. Braun Medical Inc. has not received any adverse event reports related to this issue. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. Typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

Customers who have product in their possession from the recalled product lots should discontinue use immediately.  Patients reporting any problems that may be related to the use of this product should be advised to contact a physician.

Read full release

Recall of Aspire36 and Aspire Lite, Products Marketed as Dietary Supplements
Source: Palo Alto Labs Issues a Voluntary Nationwide Recall of Aspire36 and Aspire Lite, two Products Marketed as Dietary Supplements, Firm Press Release, February 28, 2008.

Palo Alto Labs is conducting a nationwide recall of the company's supplement products sold under the name Aspire36 and Aspire Lite.

Lab analysis by FDA of Aspire36 and Aspire Lite samples found that the products contained Aildenafil in trace amounts and Dimethyl sildenafil thione (sulfoaildenafil) a purported analog of Sildenafil. This may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Consumers who have Aspire36 and Aspire Lite in their possession should stop using them immediately. In the event of any adverse side effects due to the consumption of these products, consumers should contact a physician right away. Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Program.

Read full release

Recall of Remaining Heparin Sodium Vial Products
Source: Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products, Firm Press Release, February 28, 2008.

Baxter International Inc. is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.

In addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials, Baxter's recall will now include the remaining lots of those products and heparin sodium injection 5000 units/mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free. This recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.

Customers have been instructed to discontinue use and segregate the recalled product from the rest of their inventory. Customers should then contact Baxter to arrange for return and replacement product.

Read full release

Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions
Source: Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions - FDA advises health care practitioners to switch suppliers and limit use of drug until problem identified, FDA Press Release, February 11, 2008.

The U.S. Food and Drug Administration announced that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.

Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock.

Heparin is commonly used before certain types of surgery, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis. In some situations, heparin treatment is initiated using a high bolus dose given directly into the bloodstream (intravenously) over a short period of time. The reported adverse events occurred in patients who were given heparin in this form of administration.

Physicians, dialysis center staff and health care providers are advised to use an alternate source of heparin or another blood-thinning drug when possible.

Read full release

Read Public Health Advisory

Read Questions and Answers

FDA Clears for Market First Decellularized Heart Valve
Source: FDA Clears for Market First Decellularized Heart Valve, FDA Press Release, February 7, 2008.

The U.S. Food and Drug Administration cleared for marketing the first replacement heart valve from donated human tissue in which the cells have been removed.

CryoLife Inc. has added a manufacturing step to its CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft (SynerGraft) that decellularizes or removes the tissue's cells and cellular debris. What remains is a scaffold of connective tissue that still functions like a human heart valve, potentially lowering the risk of an immune response and subsequent tissue rejection.

Allograft (human) heart valves are popular choices for children because they avoid the need to take blood-thinning medications on a long-term basis. The SynerGraft valve is for use in patients who require replacement of their pulmonary valve because of disease, malformation or malfunction of their own pulmonary valve or as part of another surgical procedure.

Read full notice

FDA Approves Drug-Eluting Stent for Clogged Heart Arteries
Source: FDA Approves Drug-Eluting Stent for Clogged Heart Arteries, FDA Press Release, February 1, 2008.

The U.S. Food and Drug Administration approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart. The Endeavor is the first drug-eluting stent approved since 2004.

The device is a tiny metal mesh tube coated with a small amount of a new drug, zotarolimus, developed only for use on a stent. It is crimped around a balloon and delivered to the narrowed section of the coronary artery via a long thin catheter during a procedure known as an angioplasty. Once the stent is positioned, the balloon is inflated, expanding into the vessel wall where it will remain in place, acting as a mechanical scaffold to keep the artery open. Slow release of zotarolimus over time prevents the artery from re-narrowing when new tissue begins to form.

Patients who are allergic to zotarolimus or to cobalt, nickel, chromium, or molybdenum should not receive an Endeavor stent. Caution is also recommended for people who have had recent cardiac surgery and for women who are nursing or who may be pregnant.

Read full notice

Recall of Cordis Corporation Dura Star™ RX and Fire Star™ RX PTCA Balloon Catheters
Source: Class I Recall: Recall of Cordis Corporation Dura Star™ RX and Fire Star™ RX PTCA Balloon Catheters, FDA Medical Device Recall Alert, January 14, 2008.

Cordis Corporation has recalled Fire Star™ RX and Dura Star™ RX PTCA Balloon Catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. (No lots above 13329055 are affected).

Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart. The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure or death.

Consumers with questions may contact Cordis, Inc. at 1-786-313-2000.

Read full notice

FDA Warns Consumers Not to Use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojimengnan)
Source: FDA Warns Consumers Not to Use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojimengnan) - These products are illegal drugs and contain undeclared active ingredients in prescription erectile dysfunction drugs, FDA Press Release, December 28, 2007.

The U.S. Food and Drug Administration (FDA) is advising consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products.

Although labeled as dietary supplements, these products do not qualify as dietary supplements because they contain undeclared active ingredients. The products are thus drugs that are illegal. The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

FDA advises consumers to discontinue use. Consumers should consult their health care providers if they have experienced any adverse events. Consumers and health care professionals can report adverse events to FDA's MedWatch program.

Read full release

New Beta Blocker to Treat High Blood Pressure
Source:FDA Approves New Beta Blocker to Treat High Blood Pressure, FDA Press Release, December 17, 2007.

The U.S. Food and Drug Administration has approved Bystolic (nebivolol) for the treatment of high blood pressure.

Bystolic is a beta blocker, a well-established class of medications that reduces blood pressure by reducing the force with which the heart pumps. It is a new drug not previously approved in the United States. Nearly one in three adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack, kidney failure, and death.

Read full release

Safety Reviews of Prilosec and Nexium Find No Evidence of Increased Rates of Cardiac Events
Source:FDA’s Safety Reviews of Prilosec and Nexium Find No Evidence of Increased Rates of Cardiac Events, FDA Statement, December 10, 2007.

FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium.
The reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect. Therefore, FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.

Read full release

Read Update of Safety Review

Read Early Communication

Recall of Encore Tabs, a Product Marketed as a Dietary Supplement
Source: Bodee LLC, Inc. Issues A Voluntary Nationwide Recall of All Encore Tabs, a Product Marketed as a Dietary Supplement, Firm Press Release, November 21, 2007.

Bodee LLC, is conducting a nationwide recall of all the company's supplement product sold under the name Encore Tabs.

Lab analysis by FDA of Encore Tabs samples found the product contains potentially harmful, undeclared ingredients. One lot of Encore Tabs contains aminotadalafil, an analog of tadalafil. This undeclared chemical poses a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program.

Read full release

FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia
Source:FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia - Agency says drug to remain on market, while safety assessment continues, FDA Press Release, November 14, 2007.

The U.S. Food and Drug Administration announced that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.

People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.

Read full release

FDA Requests Marketing Suspension of Trasylol
Source: FDA Requests Marketing Suspension of Trasylol, FDA Press Release, November 5, 2007.

The U.S. Food and Drug Administration (FDA) announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.

FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data.

Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks.

Read full release

FDA Requests Recall of 'True Man Sexual Energy,' 'Energy Max' Supplements
Source: FDA Requests Recall of 'True Man Sexual Energy,' 'Energy Max' Dietary Supplements, FDA Press Release, November 2, 2007.

The U.S. Food and Drug Administration requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules, illegal drug products that contain potentially harmful, undeclared ingredients. The products could interact with medications and cause dangerously low blood pressure.

As formulated, True Man Sexual Energy and Energy Max are classified as unapproved new drugs that do not declare the active ingredients thione, an analog of sildenafil; or piperadino vardenafil, an analog of vardenafil.

The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin.

Read full release

Recall of Welch Allyn AED 10 Automatic External Defibrillators
Source: Class 1 Recall: Welch Allyn AED 10 Automatic External Defibrillators, FDA Medical Device Recall Alert, October 26, 2007.

Welch Allyn Protocol, Inc. has recalled Welch Allyn AED 10™ Automatic External Defibrillators, manufactured between March 29, 2007 and August 9, 2007, with part numbers 970302E, 970308E, 970310E, and 970311E.

There is a possibility that these recalled devices may experience failure or unacceptable delay in analyzing a patient’s ECG resulting in possible failure to deliver the appropriate therapy. The possible failure or delay depends on the location of the defective part that stores an electrical charge on the circuit board.

Customers may call Welch Allyn’s Technical Support at 1-800-462-0777. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Read full notice

Ongoing Safety Review of Aprotinin Injection (marketed as Trasylol)
Source: FDA Issues Early Communication About an Ongoing Safety Review of Aprotinin Injection, FDA Statement, October 26, 2007.

The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Aprotinin Injection (marketed as Trasylol), a drug used to control bleeding during heart surgery.

FDA was notified that a research group stopped a study on Trasylol because the drug appeared to increase the risk for death compared to the other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding.

FDA recommends that health care providers review the risks and benefits of Trasylol outlined in the label and in the Early Communication about an Ongoing Safety Review, and discuss the information with their patients.

Read full release

Read Early Communication

Recall of Thoratec Corporation Implantable Ventricular Assist Devices (IVAD)
Source: Class I Recall: Thoratec Corporation Implantable Ventricular Assist Devices (IVAD), FDA Medical Device Recall Alert, October 19, 2007.

Thoratec Corporation has recalled Thoratec Corporation Implantable Ventricular Assist Devices, (IVAD), Catalog Number 10012-2555-001, serial numbers 488 or higher and manufactured and distributed from October 1, 2004 through October 22, 2007.

An implantable ventricular assist device is a mechanical pump that helps a person's heart that is too weak to pump blood through the body. The current Instructions for Use state that IVADs may be implanted or placed in the external position. If the IVAD is placed in the external position, air leaks may develop in the pneumatic driveline. These air leaks are a result of sharp bending of the driveline at the connection to the pump. This could result in not enough blood flow to and from the heart.

This recall does not affect implanted IVADs. Customers and patients with questions may call the company at 1-800-528-2577. Doctors should contact their patients if any Thoratec IVAD was placed in the external position. If patients have any questions, they should contact their doctor.

Read full release

Revisions to Labeling for Revatio
Source: FDA Announces Revisions to Labels for Cialis, Levitra and Viagra, FDA Press Release, October 18, 2007.

FDA plans to require changes in labeling for the drug Revatio, a member of the drug class known as phosphodiesterase type 5 (PDE5) inhibitors, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing. Revatio is used to treat pulmonary arterial hypertension (PAH).

Patients using Revatio who experience sudden hearing loss should continue taking their medication but should contact their health care provider for further evaluation. Because Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend patients abruptly stop taking this medication but should consult their physician if they experience sudden problems with their hearing.

Read full release

Daylight Saving Time May Affect Your Medical Equipment
Source: Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way, Medical Device Safety Alert, March 1, 2007.

Medical equipment that uses, creates or records time information about your diagnosis or treatment may not work properly when the new Daylight Saving Time (DST) ends this year and in future years. If you experience a problem, it’s most likely to occur on the following dates:

* October 28 (Old date for end of DST)
* November 4 (New date for end of DST)

Check the time your equipment is displaying on October 28, 2007, and on November 4, 2007, to assure that it’s correct.

Read full release

Approximately $71,000 of Dietary Supplements Seized at FDA Request
Source: Approximately $71,000 of Dietary Supplements Seized at FDA Request - Products alleged to violate new drug and misbranding provisions of Federal Food, Drug and Cosmetic Act, FDA Press Release, October 12, 2007.

U.S. Marshals seized approximately $71,000 of goods from FulLife Natural Options, Inc., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea.

Although these products are labeled as dietary supplements, they are being promoted by FulLife for use in treating serious conditions, such as diabetes, anemia, and hypertension.

FDA considers these products to be unapproved new drugs because they make claims related to the prevention or treatment of diseases in the products' labeling. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA.

Read full release

Medtronic's Market Suspension of Their Sprint Fidelis Defibrillator Leads
Source : Statement on Medtronic's Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads, FDA Statement, October 15, 2007.

Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety. These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Defibrillators are life-saving products for patients with a heart rhythm abnormality.

As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information. If patients have reason to believe that they have a Sprint Fidelis lead or if they do not know the model of their lead, they should contact their health care professional.

Read full release

Recall of Zencore Tabs, a Product Marketed as a Dietary Supplement
Source: Bodee LLC, Inc. Issues A Voluntary Nationwide Recall of All Zencore Tabs, a Product Marketed as a Dietary Supplement, Firm Press Release, August 31, 2007.

Bodee LLC, is conducting a nationwide recall of all the company's supplement product sold under the name Zencore Tabs.

Lab analysis by FDA of Zencore Tabs samples found the product contains potentially harmful, undeclared ingredients. One lot of Zencore Tabs contains aminotadalafil, an analog of tadalafil, and another lot of Zencore Tabs contains sildenafil, as well as sulfosildenafil and sulfohomosildenafil, both of which are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program.

Read full release

FDA Approves First Generic Versions of Coreg
Source: FDA Approves First Generic Versions of Coreg, FDA Press Release, September 5, 2007.

The U.S. Food and Drug Administration approved the first generic versions of Coreg (carvedilol). Coreg is a widely used medication that is FDA-approved to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack.

Carvedilol tablets in four strengths (3.125 milligrams, 6.25 milligrams, 12.5 milligrams and 25 milligrams) are manufactured by multiple generic drug companies. The labeling of the generic products may differ from that of Coreg because parts of the Coreg labeling are protected by patents and/or exclusivity.

Read full press release

Recall of One Lot of METABOSLIM Apple Cider Vinegar Dietary Supplement
Source: Confidence Inc. Issues a Voluntary Nationwide Recall in the United States and Canada of One Lot of METABOSLIM Apple Cider Vinegar brand dietary supplement found to contain an Undeclared Drug Ingredient, Firm Press Release, August 17, 2007.

Confidence Inc. is recalling one lot of METABOSLIMTM Apple Cider Vinegar brand dietary supplement, lot number 3001006, EXP. 102009 and UPC CODE: 92483 00102 because it contains the undeclared drug ingredient sibutramine. The product is sold in a plastic bottle with white and red labeling and contains 60 gelatin capsules.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Read full notice

FDA Approves Updated Warfarin (Coumadin) Prescribing Information
Source: FDA Approves Updated Warfarin (Coumadin) Prescribing Information - New Genetic Information May Help Providers Improve Initial Dosing Estimates of the Anticoagulant for Individual Patients, FDA Press Release, August 16, 2007.

The U.S. Food and Drug Administration announced the approval of updated labeling for the widely used blood-thinning drug, Coumadin, to explain that people's genetic makeup may influence how they respond to the drug.

Manufacturers of warfarin, the generic version of Coumadin, are to add similar information to their products' labeling. The labeling change highlights the opportunity for healthcare providers to use genetic tests to improve their initial estimate of what is a reasonable warfarin dose for individual patients. 2 million persons start taking warfarin in the United States every year to prevent blood clots, heart attacks and stroke.

Read full release

FDA Permits Restricted Use of Zelnorm for Qualifying Patients
Source: FDA Permits Restricted Use of Zelnorm for Qualifying Patients, FDA Press Release, July 27, 2007.

The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.
On March 30, 2007, the FDA asked Novartis, the manufacturer of Zelnorm, to suspend its U.S. marketing and sales because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm.

Physicians with IBS-C or CIC patients who meet the IND criteria should contact Novartis at 888- 669-6682 or 800-QUI-NTILE. Those who do not qualify for the Zelnorm treatment protocol may contact FDA's Division for Drug Information about other options at 888-463-6332.

Read full release

Recall of Thoratec® TLC-ll® Portable Ventricular Assist Device (VAD) Driver
Source: Class I Recall: Thoratec® TLC-ll® Portable Ventricular Assist Device (VAD) Driver, FDA Medical Device Recall Alert, July 26, 2007.

Thoratec® Corporation has recalled Thoratec® TLC-II® Portable Ventricular Assist Device (VAD) Driver, Catalog Number 20010-0000-032.

A ventricular assist device is a mechanical pump that helps a person’s heart that is too weak to pump blood through the body. VAD support for the patient’s circulatory system may fail. The VAD driver may stop due to earlier than expected wear-out of the compressor motor (much less than the expected 3000 hours). The compressor motor can stop without warning. When the motor fails, there is a loss of VAD support for the patient. This results in inadequate blood flow to and from the heart.
There is a risk of the driver to fail between 1500 and 3000 hours. When the 1500 hour limit has been reached, patients must stop using the device and then send it to the manufacturer for servicing. Patients should replace all drivers at 1500 hours and go back to the hospital for a new backup replacement. A patient must have a back-up or hand pump in their possession at all times. If the switch does not take place fast enough (within a minute), the patient may suffer a stroke or brain damage.

Patients may call the company at 1-925-847-8600. If patients have any questions, they should contact their doctor.

Read full notice

Recall of Thoratec® Paracorporeal Ventricular Assist System (PVAD) Source: Class I Recall: Thoratec® Paracorporeal Ventricular Assist System (PVAD), FDA Medical Device Recall Alert, July 26, 2007.

Thoratec® Corporation has recalled Thoratec® Paracorporeal Ventricular Assist System, (PVAD) Model TLC-II®, Catalog No. 14086-2550-000, manufactured from January 1, 2004 through October 2, 2006, and with expiration dates of January, 2007 to October, 2009.

The PVAD is a part of the Vascular Assist Device. A ventricular assist device is a mechanical pump that helps a person’s heart that is too weak to pump blood through the body. The PVAD may contain a black collet (circular rim) that holds a rod-like piece in place (nut). This black collet and nut was intended to be used with a cannula (a small tube) of an older design that had a larger diameter. If this black collet and nut is used with the current design of cannula that has a smaller diameter, it can disconnect during use.

The company has issued an “urgent medical device correction” notice to all VAD customers. The letter informs the customers to dispose of any expired original design cannula and not use the black collet and nut with any design VAD. Make sure that all current patients using PVADs are using the white collet nut that is packaged with the cannula.

Patients may call the company at 1-925-847-8600.

Read full notice

Shelhigh Enters Consent Order with FDA Source: Shelhigh Enters Consent Order with FDA - Agrees to Halt Distribution Until Manufacturing Deficiencies Have Been Corrected, FDA Press Release, June 22, 2007.

Shelhigh, Inc., of Union, N.J., agreed to stop distributing its implantable medical devices, used in heart surgery and other procedures, until the company brings its production processes in line with FDA standards.

The United States District Court for the District of New Jersey entered the consent order of injunction agreed to by Shelhigh. The consent order forbids Shelhigh from distributing all devices until its manufacturing methods, facilities, and controls are in compliance with FDA's current good manufacturing practice (CGMP) and Quality Systems (QS) regulation for medical devices and the medical device reporting (MDR) requirements.

Read full release

Recall of “Long Weekend” Dietary Supplement
Source: Confidence, Inc. Issues a Voluntary Nationwide Recall of all lots of Long Weekend, a Product Marketed as a Dietary Supplement, Firm Press Release, June 14, 2007.

Confidence, Inc. is conducting a voluntary nationwide recall of the product sold under the name Long Weekend. Lab analysis of Long Weekend samples found that the product contains undeclared tadalafil. FDA advises that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Consumers should discontinue use of Long Weekend and consult their health care professional. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Read full release

FDA Approves New Drug for Treatment of Pulmonary Arterial Hypertension
Source: FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension, FDA Press Release, June 15, 2007.

The U.S. Food and Drug Administration (FDA) approved Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension, a rare, life-threatening condition characterized by continuous high blood pressure within the arteries of the lungs.

Letairis, a new drug not previously approved in the United States, was granted a priority review by FDA. A priority review designation is intended for those products that address unmet medical needs. Letairis was granted orphan drug status by FDA because it treats a rare disease and meets other criteria.

Read full release

FDA Issues Safety Alert on Avandia
Source: FDA Issues Safety Alert on Avandia, FDA Press Release, May 21, 2007.

The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.

Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

Read full release

Health Risk Alert for 'True Man' and 'Energy Max' Products
Source: FDA Issues Health Risk Alert for 'True Man' and 'Energy Max' Products, FDA Press Release, May 10, 2007.

The Food and Drug Administration (FDA) is advising consumers not to purchase or use "True Man" or "Energy Max" products promoted and sold as dietary supplements throughout the United States. Both products are illegal drug products that contain potentially harmful, undeclared ingredients.

The undeclared analog ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers should discontinue use of True Man and Energy Max and consult their health care professional.

Consumers should report adverse events related to these products to MedWatch, the FDA's voluntary reporting program.

Read full release

FDA Requests Recall of All Shelhigh Medical Devices
Source: FDA Requests Recall of All Shelhigh Medical Devices, FDA Press Release, May 2, 2007.

The U.S. Food and Drug Administration (FDA) issued a formal written request to Shelhigh, Inc. to recall all of its medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns.

FDA recommends that doctors and hospitals consider using alternative products. Physicians and patients concerned about Shelhigh devices can visit www.fda.gov/cdrh/safety/041907-shelhigh.html and www.fda.gov/cdrh/medicaldevicesafety/atp/041907-shelhigh.html for more information, including a list of the company's products.

Adverse reactions or quality problems experienced with the use of these products may be reported to FDA's MedWatch Adverse Event Reporting program either online, fax, or regular mail.

Read full release

Read questions and answers

FDA Seizes All Medical Products From N.J. Device Manufacturer
Source: FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations, FDA Press Release, April 17, 2007.

U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies.

The products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts.

Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information. Physicians should consider using alternative devices. Physicians should also monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device.

Medical devices manufactured by Shelhigh include:

• Shelhigh Pericardial Patch
• Shelhigh No-React Pericardial Patch
• Shelhigh No-React PneumoPledgets
• Shelhigh No-React VascuPatch
• Shelhigh No-React Tissue Repair Patch/UroPatch
• Shelhigh Pulmonic Valve Conduit No-React Treated
• Shelhigh No-React Dura Shield
• Shelhigh BioRing (annuloplasty ring)
• Shelhigh No-React EnCuff Patch
• Shelhigh No-React Stentless Valve Conduit
• Shelhigh Internal Mammary Artery
• Shelhigh Gold perforated patches
• Shelhigh Pre Curved Aortic Patch (Open)
• Shelhigh NR2000 SemiStented aortic tricuspid valve
• Shelhigh BioConduit stentless valve
• Shelhigh NR900A tricuspid valve
• Shelhigh MitroFast Mitral Valve Repair System
• Shelhigh BioMitral tricuspid valve
• Shelhigh Injectable Pulmonic Valve System

Read full release

Read Public Health Notification and Advice of Patients

Recall of Certain Guidant Defibrillators
Source: Boston Scientific/Guidant Recall: Questions & Answers, FDA Questions and Answers, April 10, 2007.

Boston Scientific/Guidant is recalling certain Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). A faulty capacitor in these devices can cause the batteries to deplete sooner than expected.

The affected devices distributed in the US include the Contak Renewal 3 HE CRT-Ds (Models H177 and H179); Contak Renewal 3 CRT-Ds (Models H170 and H175); Vitality 2 DR ICDs (T165); Vitality 2 VR ICDs (T175); Vitality AVT ICDs (A155); Vitality DS DR ICDs (T125); and Vitality EL DR ICDs (T135).

Patients with one of the recalled devices should contact their physicians about what steps to take next.

Read full questions and answers

FDA Approves First Biologic to Treat Rare Clotting Disorder
Source: FDA Approves First Biologic to Treat Rare Clotting Disorder, FDA Press Release, March 30, 2007.

The U.S. Food and Drug Administration (FDA) licensed Ceprotin, the first biologic treatment for patients with a rare genetic defect that can cause a potentially life-threatening clotting disorder.

Ceprotin is made from the plasma of healthy human blood donors. It is a concentrated form of Protein C, a substance normally manufactured in the liver. Protein C plays an important role in controlling blood coagulation by preventing the formation and growth of blood clots.

Severe congenital Protein C deficiency is a rare genetic defect found in one to two newborns for every million births. Ceprotin is intended to treat patients when they are faced with a life-threatening situation from blood clots in the veins, or a severe skin and systemic blood clotting disorder known as Purpura fulminans.

Read full release

Discontinued Marketing of Zelnorm for Safety Reasons
Source: FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons, FDA Press Release, March 30, 2007.

The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States.

FDA is currently advising patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke.

Read full release

Read Public Health Advisory

FDA Announces Withdrawal of Pergolide Products
Source: FDA Announces Voluntary Withdrawal of Pergolide Products - Agency Working with Product Manufacturers, FDA Press Release, March 29, 2007.

The U.S. Food and Drug Administration (FDA) announced that manufacturers of pergolide drug products, which are used to treat Parkinson’s disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients’ heart valves.

The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva.

Patients taking pergolide should contact their doctors to discuss alternate treatments. Patients should not stop taking the medication, as stopping pergolide abruptly can be dangerous.

Read full release

Read Public Health Advisory

First-of-its-Kind Drug to Treat Rare Blood Disorder
Source: FDA Approves First-of-its-Kind Drug to Treat Rare Blood Disorder, FDA Press Release, March 16, 2007.

The U.S. Food and Drug Administration (FDA) approved Soliris (eculizumab), the first product for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare type of blood disorder that can lead to disability and premature death. Soliris is a new molecular entity containing an ingredient not previously marketed in the United States.

Soliris treats the breakdown of red blood cells. Soliris-treated patients required significantly fewer blood transfusions. A special risk management plan for Soliris has been developed to address the risk of serious meningococcal infection.

Read full release

Recall of Rhino Max (Rhino V Max) Dietary Supplement
Source: Cosmos Trading, Inc. Issues Voluntary Nationwide Recall of Rhino Max (Rhino V Max), a Product Marketed as a Dietary Supplement, Firm Press Release, March 16, 2007.

Cosmos Trading, Inc., announced that it is conducting a nationwide recall of the supplement product sold under the name Rhino Max (Rhino V Max). Lab analysis by FDA of Rhino Max (Rhino V Max) samples found the product contains Aminotadalafil, an analogue of Tadalafil. FDA advised that this poses a threat to consumers because Aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Consumers who have Rhino Max (Rhino V Max) in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.

Read full release

FDA Approves New Drug Treatment for High Blood Pressure
Source: FDA Approves New Drug Treatment for High Blood Pressure, FDA Press Release, March 6, 2007.

The U.S. Food and Drug Administration (FDA) today announced the approval of Tekturna (aliskiren) tablets for the treatment of high blood pressure, or hypertension, which affects an estimated 25 percent of Americans and causes increased risk of stroke, heart attack, kidney failure, heart failure and death.

Tekturna, a new molecular entity (NME), is the first high blood pressure drug approved by FDA that inhibits renin, a kidney enzyme associated with the regulation of blood pressure. Tekturna acts at the beginning of the blood pressure regulation process, while other available high blood pressure medications act at later stages.

Read full release

Recall of Defibtech Lifeline and ReviveR Automated External Defibrillators
Source: Defibtech Announces a Worldwide Voluntary Recall of Lifeline and ReviveR Automated External Defibrillators, Firm Press Release, March 6, 2007.

Defibtech, LLC, is initiating a recall of Lifeline AED® and ReviveR AEDTM (semi-automatic external defibrillators) with software versions 2.002 and earlier. The self-test software for these devices may allow a self-test to clear a previously detected low battery condition. If this situation occurs, the operator may be unaware of the low battery, and the device may be unable to deliver a defibrillation shock, which could result in failure to resuscitate a patient.

The company has provided a maintenance procedure that can be used to verify functionality of the device until the software upgrade has been installed, allowing the device to remain in service. This procedure, as well as instructions on determining the software version of a unit, can be found on the www.defibtech.com/fa2007 web page.

Defibtech will provide customers with a free software upgrade to address this issue for all affected AEDs. The software upgrade is expected to be available within the next 10 weeks.

Read full release

Daylight Savings Time May Affect Your Medical Equipment
Source: Advice for Patients: Change in Daylight Savings Time May Affect Your Medical Equipment in an Unpredictable Way, Medical Device Safety Alert, March 1, 2007.

Medical equipment that uses, creates or records time information about your diagnosis or treatment may not work properly when the new Daylight Savings Time (DST) starts and ends this year and in future years. If you experience a problem, it's most likely to occur on the following dates:

• March 11 (New date for start of DST)
• April 1 (Old date for start of DST)
• October 28 (Old date for end of DST)
• November 4 (New date for end of DST)

If you are a patient or caregiver, look at your medical equipment and its instructions to see whether it uses or displays time. If so, contact the manufacturer of the equipment and find out if it needs any software or other patch or fix so it will continue to operate correctly when daylight savings time becomes effective on March 11, 2007.

Check your medical equipment after 2:00 AM on March 11, 2007, and after 2:00 AM on April 1, 2007, to make sure it displays the correct time before you rely on it. If your medical equipment displays or uses the incorrect time, tell the manufacturer about your equipment and ask your doctor before you use it.

Remember to check the time your equipment is displaying on October 28, 2007, and on November 4, 2007, to assure that it’s correct.

Read full release

Update on Coronary Drug-Eluting Stents
Source: Update to FDA Statement on Coronary Drug-Eluting Stents, CDRH News & Events, FDA Statement, January 4, 2007.

On September 14, 2006 (updated December 7, 2006), FDA issued an initial statement related to concerns about adverse events related to coronary drug-eluting stents (DES). The statement noted that new data suggested a small but significant increased risk of stent thrombosis in patients who have been treated with the currently approved DES (the CYPHER stent and the TAXUS stent).

On December 7 and 8, 2006, the Circulatory System Devices Advisory Panel met in an effort to fully characterize the risks, timing and incidence of DES thrombosis. The purpose of this meeting were: (1) to provide a forum for the presentation of clinical data relevant to the issue of DES thrombosis (both when DES are used according to their label and in more complex patients beyond their labeled indication) and (2) to address the appropriate duration of antiplatelet therapy (aspirin plus clopidogrel) in DES patients.

Following this meeting, FDA has been carefully considering the new data presented at the meeting, the opinions from public speakers, and the Panel's deliberations an recommendations. FDA will work closely with the manufacturers of both approved DES and other DES still under study to incorporate appropriate modifications to labeling and changes to pre- and post-approval studies.

Read full release

ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events
Source: FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events, FDA Press Release, February 21, 2007.

The U.S. Food and Drug Administration (FDA) has directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks associated with the medicines, and to advise them of precautions that can be taken.

Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

The medicines that are the focus of the revised labeling and new Patient Medication Guides include the following 15 products:

• Adderall (mixed salts of a single entity amphetamine product) Tablets
• Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
• Concerta (methylphenidate hydrochloride) Extended-Release Tablets
• Daytrana (methylphenidate) Transdermal System
• Desoxyn (methamphetamine HCl) Tablets
• Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
• Focalin (dexmethylphenidate hydrochloride) Tablets
• Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
• Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
• Methylin (methylphenidate hydrochloride) Oral Solution
• Methylin (methylphenidate hydrochloride) Chewable Tablets
• Ritalin (methylphenidate hydrochloride) Tablets
• Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
• Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
• Strattera (atomoxetine HCl) Capsules

Read full release

FDA Convenes Panel to Evaluate Drug-Eluting Stents
Source: FDA Statement on Coronary Drug-Eluting Stents, CDRH News & Events, FDA Statement, December 7, 2006.

Stents are metal tubes that keep coronary arteries open to prevent heart attacks. Drug-Eluting Stents are coated with small amounts of drugs released over time to help keep the arteries from being blocked again. Recent studies suggest that the drug-coated stents are linked to a higher rate of blood clots than the bare-metal stents. FDA has been closely monitoring this information and convened a panel of independent experts in the clinical community on Dec. 7 and 8, 2006 to help FDA better assess the risk of stent thrombosis (clotting) in coronary drug-eluting stents, and make any necessary recommendations about what actions may be appropriate.

For further information, please see Questions and Answers on Coronary Drug-Eluting Stents, and FDA Statement on Coronary Drug-Eluting Stents.

Clinical Trials of Cardiovascular Therapy Halted for Safety Reasons
Source: Pfizer Stops All Torcetrapib Clinical Trials in Interest of Patient Safety , FDA Statement, December 3, 2006.

FDA was notified that Pfizer will suspend a large, Phase 3 trial evaluating the investigational cardiovascular therapy torceptrapib/atorvastatin (T/A) due to an increased rate of mortality (death) in patients receiving the combination compared to those receiving atorvastatin alone. With the T/A development program, as it does with all such development programs, FDA assured that Pfizer had the appropriate protections in place for patients participating in the drug’s development, including informed consent, a Data Safety Monitoring Board (DSMB) for its outcome study, and that the development program was done in a careful, stepwise manner.

FDA fully supports Pfizer's decision to suspend this trial. The system of biomedical research monitoring was effective in this case, assuring that once a certain signal was seen, the trial was halted. FDA will continue to work with Pfizer and other sponsors developing molecules in this class of drugs to ensure that appropriate protections are in place to identify any safety signals as early in the development process as possible.

Read full release

FDA Statement on Recommendations to FDA From the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines
Source: FDA Statement on Recommendations to FDA From the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines , FDA Press Release, September 28, 2006.

The U.S. Food and Drug Administration (FDA) values the relationship it has with the Heart Rhythm Society (HRS) and regards it as a model for how the agency can work collaboratively with provider groups to improve the environment for safe and effective use of medical products. In particular, over the past year, FDA and HRS have worked together to improve the conditions for safe and effective use of cardiac rhythm management devices. That has resulted in a new set of recommendations from HRS regarding how the broader healthcare community -- including FDA -- can take additional steps to make more effective use of these products.

Read full release

FDA and Duke Clinical Research Institute Form Partnership to Collaborate on Cardiac Safety
Source: FDA and Duke Clinical Research Institute Form Partnership to Collaborate on Cardiac Safety, FDA Press Release, September 27, 2006.

The U.S. Food and Drug Administration (FDA) announced a partnership, under the agency's Critical Path Initiative, with Duke Clinical Research Institute (DCRI) to develop a new generation of tools to identify, as early as possible, the potential effects that drugs and devices may have on the heart.

The research will be conducted using a virtual electronic database of more than 200,000 electrocardiograms (ECGs) amassed by the agency from the clinical trial data submitted as part of new drug applications.

Under the framework of this consortium, Duke and FDA researchers, together with other industry and academic consortium partners, will use the database to identify early indicators for potentially life-threatening cardiac arrhythmias. Strategies will range from the systematic comparison of variants of existing risk-evaluation techniques (to select the most efficient methods) to searching for novel ECG waveform features capable of detecting small adverse drug effects.

Read full release

First Totally Implanted Permanent Artificial Heart Approved for Humanitarian Uses
Source: FDA Approves First Totally Implanted Permanent Artificial Heart for Humanitarian Uses, FDA Press Release, September 5, 2006.

The U.S. Food and Drug Administration approved the first totally implanted artificial heart for patients with advanced heart failure involving both pumping chambers of the heart under the Humanitarian Use Device (HUD) provisions of the Food, Drug and Cosmetic Act. The AbioCor Implantable Replacement Heart, made by Abiomed, Inc, is intended for people who are not eligible for a heart transplant and who are unlikely to live more than a month without intervention. In clinical studies, this product was shown to prolong the life and improve the quality of life for critically ill patients.

Read full release

FDA Warns Consumers Not to Buy or Use Prescription Drugs from Various Canadian Websites
Source: FDA Warns Consumers Not to Buy or Use Prescription Drugs from Various Canadian Websites that Apparently Sell Counterfeit Products, FDA Press Release, August 30, 2006.

The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase prescription drugs from websites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada following reports of counterfeit versions of prescription drug products being sold by these companies to U.S. consumers. FDA is investigating these reports and is coordinating with international law enforcement authorities on this matter.

FDA recommends that consumers who have purchased drugs from these websites not use the products because they may be unsafe. Laboratory analyses are underway for intercepted product that was destined for the U.S. market. Preliminary laboratory results to date have found counterfeits of the following drug products from these websites: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the United States), Crestor, Celebrex, Arimidex, and Propecia. All of these medications require a prescription from a licensed health care provider to be legally dispensed.

Read full release

FDA Approves New Use for Plavix
Source: FDA Approves New Medical Use for Plavix – Drug Benefits Patients with Common Form of Heart Attack, FDA Press Release, August 17, 2006.

The Food and Drug Administration has expanded the approval of Plavix (clopidogrel bisulfate) for patients who have had a type of heart attack called an acute ST-segment elevation myocardial infarction (STEMI), who are not going to have coronary artery repair (angioplasty).

A STEMI is a severe heart attack caused by the sudden, total blockage of an artery. Plavix decreases the tendency for sticky blood cells called platelets to clump together and form clots, which can block blood vessels.

Read full release

FDA Clarifies Information in JAMA Article on Defibrillator Recalls
Source: Journal of American Medical Association Article on Recalls and Safety Alerts Affecting Automated External Defibrillators, FDA Statement , August 10, 2006.

A recent article in the Journal of American Medical Association (JAMA) titled Recalls and Safety Alerts Affecting Automated External Defibrillators helps inform the public about the safety of AEDs. FDA supports the kind of research and most of the conclusions reached in the JAMA article are consistent with FDA's own findings. However, there are a few points on which the agency differs.

First, the authors assert that manufacturers are unable to track AED units, making it impossible to know how many AED units were actually fixed or taken out of service. However, under FDA regulations, manufacturers are required to track AEDs and are doing so with processes in place to identify the location of a device in the event of a recall. Our records show that these devices are being tracked with a high level of accuracy.

Second, the authors state that there has been an increase in the number of AEDs affected by advisories during the study period. This is true, however, FDA believes that improvements in the devices' ability to self-diagnose hardware and software problems may contribute to this trend. This capability may result in users reporting problems before a device is ever used on a patient. Also, while more than 21 percent of AEDs were affected by an advisory, it does not necessarily mean that they malfunctioned. A device advisory is issued when a medical device has the potential to exhibit a certain failure mode, not only when a device has, in fact, failed.

Read full statement

FDA Update Statement on Boston Scientific/Guidant Pacemakers and Defibrillators
Source: FDA Update Statement on Boston Scientific/Guidant Pacemakers and Defibrillators, FDA Statement, July 11, 2006.

FDA met with Boston Scientific/Guidant to discuss the firm's announcement that several models of pacemakers and implantable defibrillators should be removed from hospital inventories because they have the potential to malfunction due to failure of the capacitor, which controls how the device holds its power supply. FDA fully supports the company's recommendation that physicians perform follow-up exams of patients with devices that may be susceptible to this malfunction. FDA is closely monitoring the situation and met with Boston Scientific/Guidant to discuss their plans to investigation the problem, inform physicians and resolve the problem as quickly as possible.

Read full statement

Recall of Welch Allyn PIC 50™ Automated External Defibrillators
Source: Class 1 Medical Device Recalls - Welch Allyn PIC 50™ Automated External Defibrillators, FDA Medical Device Recall Alert, June 30, 2006.

MRL, Inc. has recalled Welch Allyn PIC 50™ Automated External Defibrillators catalog #97108X manufactured from March 2002 through October 2004. An electrical contact problem may result in the device’s failure to provide a defibrillation shock, which could result in delay or failure to resuscitate the patient.

MRL, Inc. will provide PIC 50 owners with a loaner PIC 50 while their unit is being serviced, with instructions on how to return their unit for correction. Consumers with questions may contact the company at (800) 462-0777 or (847) 520-0300 for more information.

Read full notice

First Generic Version of Cholesterol Drug Zocor Approved
Source: FDA Approves First Generic Simvastatin, FDA Press Release, June 23, 2006.

The Food and Drug Administration approved the first generic version of Zocor® (simvastatin), an important step in the agency's effort to increase the availability of lower-cost generic medications.

Simvastatin is recommended for use along with a diet restricted in saturated fat and cholesterol to treat hypercholesterolemia (high cholesterol) and to reduce the amount of certain fatty substances in the blood such as triglycerides and other lipids.

Simvastatin Tablets (5 mg, 10 mg, 20 mg and 40 mg) are manufactured by IVAX Pharmaceuticals, Inc. (IVAX) of Northvale, New Jersey and simvastatin tablets (80 mg) are manufactured by Ranbaxy Pharmaceuticals, Inc. of Princeton, New Jersey.

Read full release

Recall of Welch Allyn AED20 Automatic External Defibrillators
Source: MRL, Inc. a Welch Allyn Company, Issues a Voluntary Worldwide Recall of Selected AED20 Automatic External Defibrillators, Firm Press Release, June 15, 2006.

MRL, Inc., a Welch Allyn company, announced it is initiating a voluntary worldwide Class I recall of 580 AED20 Automatic External Defibrillators manufactured in Buffalo Grove, IL between April and October of 2003, with serial numbers 205199 through 205786. These 580 AED20's may experience failure or unacceptable delay in analyzing the patient's ECG and may fail to deliver appropriate therapy, which possibly could result in failure to resuscitate the patient. This will occur in combination with an error message on the device display reading "DEFIB COMM FAIL SELF TEST FAILED."

Customers with questions may contact the company at 1.800.462.0777 or 1.847.520.0300 for more information. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program.

Read full release

FDA Will Allow Health Claim on Barley Products
Source: FDA Finalizes Health Claim Associating Consumption of Barley Products with Reduction of Risk of Coronary Heart Disease, FDA Press Release, May 19, 2006.

The Food and Drug Administration announced that it has finalized a rule that allows foods containing barley to claim that they reduce the risk of coronary heart disease. Specifically, whole grain barley and dry milled barley products such as flakes, grits, flour, and pearled barley, which provide at least 0.75 grams of soluble fiber per serving, may bear the following claim:

"Soluble fiber from foods such as [name of food], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies [x] grams of the soluble fiber necessary per day to have this effect."

Read full release

FDA Approves Generic Version of Cholesterol Drug Pravachol
Source: FDA Approves First Generic Pravastatin, FDA Press Release, April 24, 2006.

The Food and Drug Administration approved the first generic version of Bristol-Myers Squibb's Pravachol (Pravastatin Sodium Tablets), an important step in the agency's effort to increase the availability of lower-cost generic medications.

Pravastatin is indicated for the treatment of individuals with high cholesterol levels (hyperlipidemia) or who are at increased risk for atherosclerosis-related cardiac and cardiovascular events, such as heart attack and stroke in which high cholesterol levels are a factor.

The Bristol-Myers Squibb's patent for the drug expired on April 20. Pravastatin Sodium Tablets (10mg, 20mg and 40mg) are manufactured by TEVA Pharmaceuticals in Kfar Sava, Israel.

Read full release

FDA Issues Public Health Advisory for Heart Bypass Drug
Source: FDA Issues Public Health Advisory for Trasylol, FDA Press Release, February 8, 2006.

The Food and Drug Administration issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that Trasylol (aprotinin injection), a drug used to prevent blood loss during surgery, has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery.

FDA advises health care providers to be aware of the following:

• Physicians who use Trasylol should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart or central nervous system and promptly report adverse event information to Bayer, the drug manufacturer, or through the FDA Medwatch program.
• Physicians should consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.
• FDA is working with the manufacturer to examine the safety and benefits of Trasylol in light of the recent data and the evolving practice of medicine.
• Patients should discuss all major risks for heart bypass surgery with their healthcare providers. These include the risks for bleeding and the available ways to lessen the risk for bleeding.

Read full release

FDA Approves New Treatment for Chest Pain
Source: FDA Approves New Treatment for Chest Pain, FDA News Release, January 31, 2006

The Food and Drug Administration (FDA) announced the approval of Ranexa (ranolazine), a new drug for the treatment of chronic angina. Ranexa, a new molecular entity (NME), is the first drug approved to treat chronic angina in over ten years. Although several pharmacological activities of ranolazine have been described, the precise way the drug works is not fully understood. Because Ranexa affects electrical conduction in the heart (prolong the QT interval), it should only be used by patients who have not responded to other anti-anginal (long-acting nitrates, calcium channel blockers and beta blockers) drugs.

Read full release

Class 1 Recall: Boston Scientific Flextome® Cutting Balloon Systems
Source:Class 1 Recall: Boston Scientific Flextome® Cutting Balloon Systems, FDA Medical Device Recalls, December 7, 2005

Boston Scientific Corporation is recalling all Flextome Cutting Balloon® Device Monorail® Delivery Systems. The catheter shaft used to place the balloon in the artery may separate during withdrawal of the device from the patient. If that happens, the procedure may be prolonged, or more in-depth surgery may be required to remove the broken-off piece.

This product should no longer be used on patients and should be returned to Boston Scientific. This action does not affect patients who have already received treatment because the potential problem occurs during the procedure.

Read full notification

Novartis Nutrition Corporation Issues Nationwide Recall of Diabetisource® AC Product
Source: Novartis Nutrition Corporation Issues Nationwide Recall of One Lot of its Diabetisource® AC Product, Firm Press Release, November 16, 2005.

Novartis Nutrition Corporation is recalling 2,712 bottles of an enteral feeding formula which was incorrectly labeled as Diabetisource® AC 1.5 Liter bottles lot 2135L. The product contained in these bottles is Resource Diabetic® TF a tube feeding formulated for diabetes which contains sodium and calcium caseinate, components of milk. People with an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume this product. In addition the two products are not nutritionally equivalent.

Healthcare professionals administering to patients who have an allergy or sensitivity to milk should immediately stop using this product. Healthcare institutions that have received shipping cartons labeled Resource Diabetic® TF lot number 2135L or bottles labeled Diabetisource® AC 1.5 Liter bottles lot 2135L should contact Novartis Customer Services at 1-800-333-3785. Consumers who have questions can contact this same 800 number.

Read full release

FDA Updates Preliminary Public Health Notification on Certain Guidant Implantable Defibrillators
Source: Update of FDA Preliminary Public Health Notification: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators, October 13, 2005

FDA has issued an update to its July 14, 2005 Preliminary Public Health Notification about malfunctions occurring with Guidant’s PRIZM® 2 and CONTAK RENEWAL® implantable cardioverter defibrillator devices, which were the subjects of a Class I recall announced by the Food and Drug Administration (FDA) on July 1, 2005.

The affected devices are:

• VENTAK PRIZM® 2 DR, Model 1861, manufactured on or before April 16, 2002
• CONTAK RENEWAL®, Model H135, manufactured on or before August 26, 2004
• CONTAK RENEWAL® 2, Model H155, manufactured on or before August 26, 2004.

Read full Notification

Drug Use and Safety in the Aftermath of Hurricane Katrina
Source: FDA Offers Valuable Information about Drug Use and Safety in the Aftermath of Hurricane Katrina, August 30, 2005

Drugs that have been exposed to flood or unsafe municipal water may become contaminated. This contamination may lead to diseases that can cause serious health effects.

Ideally, these exposed products – even in their original containers – should be discarded. But in many situations, these drugs may be lifesaving and replacements may not be readily available. For life-saving drugs, if the container is contaminated but the contents appear unaffected – for instance, if the pills are dry -- the pills may be used until they can be replaced. If they are wet, they are contaminated and should be discarded.

If a contaminated product is medically necessary and can’t be replaced quickly, contact a healthcare provider – for example, the Red Cross, a hospital, or an emergency medical facility – for guidance.

Read full announcement

FDA Alerts U.S. Residents to Recall of Counterfeit "Lipitor" Sold in the U. K.
Source: FDA Alerts U.S. Residents to Recall of Counterfeit "Lipitor" Sold in the United Kingdom , FDA Press Release, July 29, 2005

The Food and Drug Administration (FDA) is alerting U.S. residents to the recent recall of a batch of counterfeit "Lipitor" (atorvastatin) sold in the United Kingdom (U.K.).

The affected product is 20 mg. "Lipitor" and is sold in packages of 28 tablets.  The drug packages are marked with batch number 004405K1 and an expiration date of "11 2007."  The batch number can be found on the end of the box next to the expiration date and on the foil backing of the drug's blister pack.  Legitimate U.K. Lipitor also has this same batch number.

Read full Press Release

FDA Announces Guidant’s Class I Pacemaker Recall
Source: FDA News, July 22, 2005

FDA is notifying health care providers and patients that Guidant Corporation is voluntarily recalling certain pacemakers.

Only the following models are affected by this recall. All were manufactured between November 25, 1997 and October 26, 2000.

• PULSAR® MAX Models 1170, 1171, 1270
• PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
• DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
• MERIDIAN® Models 0476, 0976, 1176, 1276
• PULSAR MAX II Models 1180, 1181, 1280
• DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
• CONTAK TR® Model 1241
• VIRTUS PLUS® II* Models 1380, 1480
• INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

The FDA has this action as a Class I recall. Recall classifications can fall into one of three categories, with Class I being the most serious. FDA is not making a recommendation about whether a patient who has one of the Guidant pacemakers affected by this recall should have it replaced. This is a decision that should be made by the patient in consultation with his or her physician,

Read Full Press Release

Guidant Contacts Doctors about Certain Pacemakers
Source: Guidant Initiates Worldwide Physician Communications Regarding Important Safety Information and Corrective Action about Certain Pacemakers, Firm Press Release, July 18, 2005

Guidant Corporation announced that it is voluntarily advising physicians about important safety information regarding certain devices. Guidant apprised FDA of this action, and FDA may classify this action as a recall. This communication advises physicians and their patients of safety information and is intended to limit adverse events. Physicians should use this information to decide how best to treat their patients.

A subset of the following devices manufactured between November 25, 1997 and October 26, 2000 are impacted:

• PULSAR(R) MAX
• PULSAR
• DISCOVERY(R)
• MERIDIAN(R)
• PULSAR MAX II
• DISCOVERY II
• VIRTUS PLUS(R) II
• INTELIS II
• CONTAK(R) TR

These products, which are of an earlier generation design, have not been sold or implanted for the last four years.

Read full Press Release

Advice for Patients with VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators
Source: Advice for Patients with VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators, CDRH, July 15, 2005

FDA has issued a document providing advice for patients with certain recalled Guidant implantable defibrillators.

The devices involved are:

• PRIZM® 2 DR, Model 1861, manufactured before April 16, 2002
• CONTAK RENEWAL®, Model H135, manufactured before August 26, 2004
• CONTAK RENEWAL® 2, Model H155, manufactured before August 26, 2004

Read full document

FDA issues Preliminary Public Health Notification on Certain Guidant Implantable Defibrillators
Source: FDA Preliminary Public Health Notification: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators, July 14, 2005

FDA has issued a Public Health Notification which provides clinicians with current information and guidance concerning malfunctions occurring with Guidant’s PRIZM® 2 and CONTAK RENEWAL® implantable cardioverter defibrillator (ICD) devices, which were the subjects of a Class I recall announced by FDA on July 1, 2005.

The affected devices are:

• VENTAK PRIZM® 2 DR, Model 1861, manufactured on or before April 16, 2002
• CONTAK RENEWAL®, Model H135, manufactured on or before August 26, 2004
• CONTAK RENEWAL® 2, Model H155, manufactured on or before August 26, 2004.

Read full Notification

FDA Updates Consumers on Guidant Corporation’s Implantable Defibrillators
Source: FDA Updates Consumers on Guidant Corporation’s Implantable Defibrillators, FDA Press Release, July 1, 2005

As the Food and Drug Administration (FDA) continues to evaluate the safety and performance of certain implantable defibrillators manufactured by Guidant Corporation, the Agency has now classified the recalled devices. This additional information on the relative health risks of the devices will help patients and doctors take appropriate action, if necessary.

Classifications can fall into three categories, with Class I being the most serious. These numerical classifications are based on the probability that the device failure could lead to adverse health effects.

The affected devices are:

• PRIZM 2 DR, CONTAK RENEWAL, and CONTAK RENEWAL 2 Devices- Class I
• VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL AVT Devices- Class II
• CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF Devices- Class II

Read full press release

Boston Scientific Announces Recall of Certain Vascular Grafts
Source: Boston Scientific Announces Worldwide Recall of Hemashield® Vantage™ Peripheral Vascular Grafts, Firm Pre