FDA MedWatch - 2008 Safety Alerts for Human Medical Products

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2008 Safety Alerts for Human Medical Products
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2008 Medical Product Safety Alerts, listed in reverse chronological order (most recent first). For an alphabetical listing, return to the categories on this page. You may also search the entire MedWatch site by keyword at the top of this Safety Information page.

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Innohep (tinzaparin sodium injection): Audience: Hematological and Nephrological healthcare professionals, hospital risk managers
[Posted 12/02/2008] FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed.

In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older. Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both. This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep.

[December 02, 2008 - Communication about an Ongoing Safety Review - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Starcaps Dietary Supplement Capsules: Audience: Consumers, healthcare professionals
[Posted 11/26/2008] Balanced Health Products, Inc. announced a recall of STARCAPS due to the presence of an undeclared drug ingredient, Bumetanide. Bumetanide is a diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including nephrotic syndrome. Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Consumers should not take Bumetanide if they are allergic to sulfonamides. Significant drug interactions with Bumetanide, such as with digoxin and lithium, may lead to an increase risk of toxicity. Patients may also be at an increased risk of hypotension (low blood pressure), fainting (syncope) and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication and take STARCAPS with undeclared Bumetanide. Consumers who have this product should immediately discontinue taking it and return the product to the manufacturer. See the company's press release for specific lot number information.

[November 24, 2008 - Press Release - Balanced Health Products, Inc.]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Zhen De Shou Fat Loss Capsules: Audience: Consumers, healthcare professionals
[Posted 11/26/2008] Fashion Sanctuary announced a recall of Zhen De Shou Fat Loss Capsules because FDA analysis found the product to contain undeclared sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. This poses a potential threat to consumers because 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. The product was primarily distributed in the U.S and sold via the Internet and the recall affects all lot codes and use by dates. Consumers who may have purchased product from this company should immediately discontinue using the product.

[November 23, 2008 - Press Release - Fashion Sanctuary]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Phenytoin (marketed as Dilantin, Phenytek and generics) and Fosphenytoin Sodium (marketed as Cerebyx and generics): Audience: Neurological healthcare professionals
[Posted 11/24/2008] FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed by FDA, and information for patients and healthcare professionals to consider, can be found in the links provided below.

[November 24, 2008 - Drug Information Page - FDA]
[November 24, 2008 - Information for Healthcare Professionals - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Animas Corporation Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump: Audience: Consumers, endocrinological healthcare professionals
[Posted 11/20/2008] Animas Corporation and FDA informed consumers and healthcare professionals of a nationwide recall of battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump. The battery caps used with the above infusion pumps were manufactured from June 1, 2008 through July 31, 2008, and were distributed from June 16, 2008 through August 1, 2008.

There may be an intermittent loss of contact between the battery cap and the battery compartment in the pump which may result in the device resetting. This can cause the device to stop administering insulin, which could result in an excess level of glucose in the blood (hyperglycemia). Additionally, this failure may lead to user confusion in the amount of insulin administered, contributing to errors in future doses, which may result in lower than normal level of glucose in the blood (hypoglycemia). Healthcare professionals are advised to ensure that their patients replace the battery cap on their insulin pump.

[November 20, 2008 - Recall Notice - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Benzoyl Peroxide Acne Cream 10% marked as: DG Maximum Strength Acne Medicated Gel Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication Equate: Medicated Acne Gel: Audience: Consumers, dermatologists, pharmacists, other healthcare professionals
[Posted 11/17/2008] CSI USA Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of all lots of 1 ounce tubes of 10% Benzoyl Peroxide Acne Cream. The products were recalled because samples of the products were found to contain bacteria, Burkholderia Cepacia, formerly known as Pseudomonas Cepacia. There may be an increased health risk of infections for individuals with cuts, scrapes, rashes or other compromised skin conditions; or those with weakened or suppressed immune systems. Consumers should discontinue using the product and should return it to the place of purchase. See the company's press release for photos of product packaging.

[November 13, 2008 - Press Release - CSI USA Inc.]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D) Etidronate (Didronel) Ibandronate (Boniva) Pamidronate (Aredia) Risedronate (Actonel, Actonel W/Calcium) Tiludronate (Skelid) Zoledronic acid (Reclast, Zometa): Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals
[Posted 11/12/2008] FDA issued an update to the Agency's review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer. FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years. The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events. Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Additionally, increasing dose or duration of bisphosphonate therapy was not associated with an increase rate of atrial fibrillation. Healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication.

[November 12, 2008 - Update to the October 1, 2007 Early Communication about the Ongoing Safety Review of Bisphosphonates - FDA]

Previous MedWatch alert:
[October 1, 2007]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas): Audience: Consumers, pediatricians, other healthcare professionals
[Posted 11/12/2008] Johnson & Johnson, Merck Consumer Pharmaceuticals Company and FDA notified consumers and healthcare professionals of a voluntary recall of Infants' Mylicon Gas Relief Dye Free Drops ( Lot No. SMF007 and SMF008) sold in 1 oz plastic bottles that were distributed after October 5, 2008, nationwide. The product was recalled because some bottles could include metal fragments that were generated during the manufacturing process. Parents who have given the product to their infant and are concerned should contact their healthcare professional.

[November 07, 2008 - Press Release - Johnson & Johnson • Merck Consumer Pharmaceuticals Company]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Propafenone HCl Tablets 150 mg, 225 mg, and 300 mg Isosorbide Mononitrate Extended Release Tablets 30 mg and 60 mg Morphine Sulfate Extended Release Tablets 15 mg Morphine Sulfate Immediate Release Tablets 15 mg and 30 mg Dextroamphetamine Sulfate Tablets 10 mg: Audience: Pharmacists, other healthcare professionals, patients
[Posted 11/10/2008] Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products (Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets, and Dextroamphetamine Sulfate Tablets). The products were recalled because they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient that could result in patients receiving as much as twice the expected dosage of these drugs, which could cause serious or life-threatening consequences.
Overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low blood pressure with Isosorbide Mononitrate; respiratory depression and low blood pressure with Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate. Patients who experience any adverse reactions to these drugs should contact their healthcare professional immediately. See the manufacturer's recall notice for specific lot numbers of the products affected by this recall.

[November 07, 2008 - Press Release - Ethex Corp]

Previous MedWatch Alert:

[October 16, 2008]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien): Audience: Patients with insulin-dependent diabetes; pharmacists
[Posted 11/06/2008] Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.

[November 06, 2008 - Recall Notice - FDA]
[November 05, 2008 - News Release - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator: Audience: Healthcare professionals
[Posted 10/31/2008] FDA notified healthcare professionals of a Class I Recall of the Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator. This device has not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices. The manufacturer has submitted no evidence to FDA to support any of their claims that the product could treat or cure such diseases as cancer, depression, infection and pain. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.

[October 31, 2008 - Recall Notice - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Thoratec HeartMate II Left Ventricular Assist System: Audience: Cardiologists, cardiovascular surgeons, hospital risk managers
[Posted 10/28/2008] Thoratec Corporation notified healthcare professionals of a worldwide correction of the HeartMate II Left Ventricular Assist System (HM II LVAS), of all serial numbers (having Catalogue No. 1355 or 102139), distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump, and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months, and 11.4% at 36 months. Healthcare professionals with patients supported by a HeartMate II LVAS should assess the wear and fatigue of the percutaneous lead and provide proper instruction to patients on the management and care of the lead.

[October 24, 2008 - Press Release - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Transvaginal Placement of Surgical Mesh: Audience: Hospital surgical staff, OB/GYN physicians, other healthcare professionals
[Posted 10/21/2008] FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA provided recommended actions for both physicians and patients to reduce the risks.

[October 21, 2008 - Public Health Notification - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Raptiva (efalizumab): Audience: Dermatological healthcare professionals, patients
[Posted 10/17/2008] FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections with the use of Raptiva. In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.

Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay. Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug.

Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

[October 16, 2008 - News Release - FDA]
[October 2008 - Prescribing Information - Genentech]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Dextroamphetamine Sulfate 5mg Tablets: Audience: Pharmacists, other healthcare professionals, patients
[Posted 10/16/2008] Ethex Corp and FDA notified healthcare professionals of a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. Taking a higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with any questions.

[October 15, 2008 - Press Release - Ethex]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Over The Counter Cough and Cold Medications: Audience: Pediatric and primary healthcare professionals, consumers
[Posted 10/09/2008] FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.

[October 09, 2008 - News Release - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Nebion HLX-8 Magnetic Resonance Device: Audience: Healthcare professionals, consumers
[Posted 10/03/2008] FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.

[October 03, 2008 - Recall Notice - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Medtronic INDURA 1P Intrathecal Catheter Sutureless Pump Connector Revision Kit Intrathecal Catheter Pump Segment Revision Kit: Audience: Physical medicine and rehabilitation specialists, anesthesia healthcare professionals, hospital surgical service managers
[Posted 10/02/2008] Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic intrathecal catheters and intrathecal catheter revision kits used with the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps that store and deliver parenteral drugs to the intrathecal space. The products were recalled because of potential misconnections of the Medtronic Sutureless Connector Catheters from the catheter port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector. See the FDA Recall Notice for recommendations for healthcare professionals.

[October 01, 2008 - Recall Notice - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Statin drugs and amyotrophic lateral sclerosis (ALS): Audience: Neurologists, cardiologists, consumers
[Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.

[September 29, 2008 - News Release - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Epoetin alfa - Early Communication about an Ongoing Safety Review: Audience: Neurological healthcare professionals
[Posted 09/23/2008] FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product. Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.

FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, FDA will communicate our conclusions and recommendations to the public. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.

[September 26, 2008 - Early Communication about an Ongoing Safety Review - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%: Audience: Hospital ER and ICU medical and nursing personnel, risk managers
[Posted 09/23/2008] Ucyclyd Pharma, Inc. informed healthcare professionals of the detection of particulate matter in the Ammonul Injection product. This particulate matter may impact the safe use of Ammonul. To ensure optimal patient care, healthcare providers are being instructed to use a MilIex Durapore GV 33 mm Sterile Syringe Filter (0.22 µm ) during the admixture process when injecting Ammonul into the 10% Dextrose IV bag. Since this particulate matter may not be readily seen on visual inspection, a filter must be employed in all cases regardless of whether particulate matter is seen in the vial. Testing has confirmed the removal of this specific particulate when using this filter to admix Ammonul. Contact Ucyclyd Pharma, 1-888-829-2593, or 1-800-900-6389 -- a representative is available 24 hours, seven days a week.

[September 15, 2008 - Letter - Ucyclyd Pharma, Inc.]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Tarceva (erlotinib): Audience: Oncological healthcare professionals
[Posted 09/23/2008] OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN. Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range. New information from a pharmacokinetic study in patients with moderate hepatic impairment associated with significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections.

[September 2008 - Letter - OSI Pharmaceuticals, Inc. and Genentech, Inc.]
[September 12, 2008 - Label - OSI Pharmaceuticals, Inc. and Genentech, Inc.]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Phosphocol P 32 (Chromic Phosphate P 32 Suspension): Audience: Oncologists, other healthcare professionals
[Posted 09/18/2008] Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease. Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). This drug is not indicated in the intra-articular treatment of hemarthroses. Additionally, post marketing experience identified radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity. Healthcare professionals should refer to the product's revised prescribing information for updated information regarding the appropriate use of Phosphocol P 32.

[August 29, 2008 - Letter – Covidien]
[August 2008 - Label – Covidien]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Infant Formula Manufactured in China: Audience: Consumers, pediatricians
[UPDATE 10/03/2008] FDA issued the results of its interim safety and risk assessment that evaluated the melamine exposure in infant formula and in other foods. FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns. FDA continues to advise consumers not to purchase infant formula manufactured in China from internet sites or from other sources and to contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status.

[UPDATE 09/22/2008] FDA contacted companies who manufacture infant formula for distribution in the United States and has learned that they are not importing formula or source materials from China. FDA, in conjunction with state and local officials, began a nation-wide investigation to check Asian markets for Chinese-manufactured infant formula and have not found Chinese infant formula present on shelves in these markets. FDA is advising consumers not to purchase infant formula manufactured in China from internet sites or from other sources.

[Posted 09/12/2008] FDA issued a Health Information Advisory to consumers and healthcare professionals regarding milk-based infant formula manufactured in China. The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can cause kidney diseases. Currently, no Chinese manufacturers of infant formula have fulfilled the requirements to sell this product in the United States. FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Caregivers should not feed infant formula manufactured in China to infants and should replace any product from China with an appropriate infant formula manufactured in the United States. Individuals should contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status.

[October 03, 2008 - News Release - FDA]
[September 20, 2008 - Statement - FDA]
[September 12, 2008 - News Release – FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

LifePak CR Plus Automated External Defibrillators: Audience: Emergency medical personnel, other healthcare professionals
[UPDATE 09/16/2008] Recall classified by FDA as Class I. See the Recall notice for product numbers affected by this recall.

[Posted 09/11/2008] Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), used by emergency or medical personnel to treat adults in cardiopulmonary arrest. The product was recalled because the AED instructs the responder by voice prompts to press the shock button which is not visible because it is covered, thereby making the responder unable to provide shock therapy. The AED device should be removed from service, or the manufacturer-provided diagram should be consulted to remove and discard the shock button cover.

[September 11, 2008 - Recall Notice – FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Rituxan (rituximab): Audience: Oncologists, rheumatologists, other healthcare professionals, consumers
[Posted 09/11/2008] Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan. Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated.

[September 2008 - Letter – Genentech]
[September 2008 - Label – Genentech, Biogen Idec]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Disposable Battery Operated Lavage System (BOLS): Audience: Operating room, outpatient and emergency room supervisory staff and physicians, risk managers
[Posted 09/08/2008] FDA notified healthcare professionals about the potential for sparks, fires, toxic fumes, and explosions when disposable battery operated lavage systems’ (BOLS) cables are cut. BOLS are used in the OR, ER, burn units, and nursing units. The cutting of the battery pack's cable can lead to a short circuit, causing the batteries to discharge rapidly, producing intense heat and flammable gases with a resulting explosion that expels flammable gases and toxic chemicals endangering both patients and staff. Recommendations for avoiding this risk are provided in the medical device safety alert.

[September 04, 2008 - Medical Device Safety (Reprinted Article) – FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab): Audience: Rheumatological, gastroenterological and infectious disease healthcare professionals
[Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses. For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified.

[September 4, 2008 - Information for Healthcare Professionals - FDA]
[September 4, 2008 - Press Release - FDA]

Previous MedWatch Alerts:

[June 3, 2008]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Pacific Consolidated brand Mobile Oxygen Storage Tank: Audience: Emergency healthcare professionals, military emergency/disaster/field hospital/aviation personnel
[Posted 08/28/2008] Pacific Consolidated Industries, LLC, and FDA notified healthcare professionals of the Class I Recall of the Mobile Oxygen Storage Tank manufactured and distributed between January - March 2007, because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. The mobile oxygen storage tank is used in military aircraft for treating wounded patients and in disaster areas to quickly supply oxygen to patients. Facilities with the Mobile Oxygen Storage Tank should keep the device in quarantine until arrangements are made to ship the device back to the manufacturer.

[August 28, 2008 - Recall Notice - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Tysabri (natalizumab): Audience: Neurologists, other healthcare professionals, patients
[Posted 08/25/2008] FDA informed healthcare professionals of two new cases of progressive multifocal leukoencephalopathy (PML) in European patients receiving Tysabri monotherapy for multiple sclerosis for more than one year. PML, which is usually fatal, is a known risk of Tysabri treatment, but previous cases in patients with multiple sclerosis were seen in combination with other immunomodulatory therapies. Approximately 39,000 patients have received treatment with Tysabri worldwide, with approximately 12,000 patients receiving treatment for a least one year. No new cases have been seen in the US, where about 7,500 patients have received the drug for greater than one year and approximately 3,300 patients have received the drug for at least one and one-half years. In the U.S., Tysabri is available only to patients with relapsing multiple sclerosis or Crohn's disease who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under this program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections. While the two patients who developed PML were on monotherapy, the FDA still believes that Tysabri monotherapy may confer a lower risk of PML than when Tysabri is used together with other immunomodulatory medications. Prescribing information for Tysabri will be revised to include information informing prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy. Healthcare professionals should continue to monitor patients for sign and symptoms of PML. Additionally, Tysabri should not be infused if PML is suspected.

[August 25, 2008 - Information for Healthcare Professionals - FDA]

Previous MedWatch Alert:

[February 27, 2008]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Ezetimibe/Simvastatin (marketed as Vytorin) Simvastatin (marketed as Zocor) Ezetimibe (marketed as Zetia): Audience: Endocrinologists, cardiologists, other healthcare professionals, patients
[Posted 08/21/2008] FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study.
FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency.

[August 21, 2008 - Early Communication about an Ongoing Safety Review - FDA]

Previous MedWatch Alerts:

[January 25, 2008]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Boston Scientific NexStent Monorail NexStent Carotid Stent and Monorail Delivery System: Audience: Cardiologists, hospital risk managers
[Posted 08/14/2008] Boston Scientific and FDA informed healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. This recall does not affect stents that have already been implanted. Patients should contact their healthcare professional if they have any questions.

[August 14, 2008 - Recall Notice - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Vivitrol (naltrexone): Audience: Primary healthcare physicians, internists, other healthcare professionals
[Posted 08/12/2008] FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone injection.

[August 12, 2008 - Drug Information Page - FDA]
[August 12, 2008 - Information for Healthcare Professionals - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Simvastatin Used With Amiodarone: Audience: Cardiologic healthcare professionals, pharmacists, other healthcare professionals
[Posted 08/08/2008] FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.

[August 08, 2008 - Drug Information Page - FDA]
[August 08, 2008 - Information for Healthcare Professionals - FDA]

[Labels - Simvastatin - DailyMed]
[Labels - Amiodarone - DailyMed]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software): Audience: Cardiothoracic healthcare professionals, perfusionists, hospital risk managers, biomedical engineers
[Posted 08/01/2008] Levitronix and FDA notified healthcare professionals of a Class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles manufactured by Levitronix, GmbH, Zurich, Switzerland and distributed from January, 2001 through March, 2008. The Blood Pumping System is used to provide short-term extracorporeal circulatory support during cardiac and other types of surgeries. This device temporarily replaces the function of the heart and lungs in order to maintain the appropriate circulation of blood and oxygen levels in the body during the surgical procedure. A July 24, 2008 Levitronix device correction letter informed physicians not to use Valleylab Force FX-C or SSE2L electrosurgery devices with the CentriMag Blood Pumping System because use may result in stoppage of the pump and may cause serious injury or death. This recall action is an interim fix while the firm further investigates the source of the problem.

[August 01, 2008 - Recall Notice - FDA]
[July 24, 2008 - Letter - Levitronix]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Viapro 375mg Capsules: Audience: Consumers, healthcare professionals
[Posted 07/31/2008] EG Labs, LLC, notified consumers and healthcare professionals not to buy or use Viapro 375mg Capsules because one lot of the product was found to contain a potentially harmful undeclared ingredient, thio-methisosildenafil, an analog of sildenafil, a FDA approved product used to treat erectile dysfunction in men to enhance sexual performance. The undeclared ingredient 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 products containing nitrates. Consumers who have this product should discontinue using it and consult their healthcare professional if they experience any problems that may be related to taking Viapro.

[July 23, 2008 - Press Release - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

Audience: Oncologists, other healthcare professionals
[UPDATE 12/02/2008] FDA issued Q&As for recently approved Medication Guides. The Medication Guides were developed to provide patients with important information about the risks of using ESAs. The information in the Medication Guides may affect a patient’s decision to take the drug and it gives patients a starting point for discussion with their healthcare provider about the medical decision to prescribe an ESA.

[UPDATE 08/08/2008] Amgen, Ortho Biotech letter added.

[Posted 07/31/2008] FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated. Additional revisions to prescribing information that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and when to initiate and discontinue ESA dosing will be forthcoming. FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.

[December 02, 2008 - Q&As on Medication Guides - FDA]
[November 2008 - Medication Guides: Aranesp, Epogen, Procrit]

[August 07, 2008 - Letter - Amgen, Ortho Biotech]

[July 30, 2008 - Follow Up to Ongoing Safety Review - FDA]
[July 30, 2008 - Label - Aranesp]

[July 30, 2008 - Label - Procrit]

[July 30, 2008 - Label - Epogen]

Previous MedWatch Alerts:

[03/12/2008]
[01/03/2008]

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Mitoxantrone Hydrochloride (marketed as Novantrone and generics)

Audience: Neurological and Oncological healthcare professionals, risk managers
[Posted 07/29/2008] FDA reminded health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. FDA offered additional recommendations for cardiac monitoring to detect late-occurring cardiac toxicity, and provided information for patients with multiple sclerosis who receive the drug.

These recommendations were established in 2005 in response to post-marketing reports and case reports in the medical literature that described decreases in LVEF or frank congestive heart failure in patients with MS who had received cumulative doses of mitoxantrone that were lower than 100 mg/m². Since that time, FDA has received information from a post-marketing safety study that demonstrated there is poor adherence to these recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to cardiac monitoring recommendations for patients with MS.

[July 29, 2008 - Information for Healthcare Professionals - FDA]
[March 2005 - Label - Novantrone - Serono, Inc.]

Previous MedWatch Alerts:

[05/24/2005]

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Abacavir (marketed as Ziagen) and Abacavir-containing Medications: Audience: Infectious disease and medical genetics healthcare professionals
[Posted 07/24/2008] FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. FDA reviewed data from two studies that support a recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects. Genetic tests for HLA-B*5701 are available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701.

[July 24, 2008 - Information for Healthcare Professionals - FDA]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)

Audience: Radiological healthcare professionals, cardiologists, hospital risk managers
[Posted 07/17/2008] FDA is updating healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents, a sterile suspension of perflutren gas microspheres, indicated for use in certain patients with suboptimal echocardiograms, to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.These changes reflect conclusions of FDA reviews of information received following the addition of new Contraindications and Warnings in October 2007. The revised Boxed Warning and Warnings highlight the risk of serious cardiopulmonary reactions during or within 30 minutes following the administration of these products and recommend that high risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes post administration of these contrast agents. In addition, several of the Contraindications that were added to the labeling in October, 2007 were removed because FDA determined that, in some patients, the benefits from the diagnostic information obtained through the use of Definity or Optison may outweigh the risk for serious cardiopulmonary reactions, even among some patients at particularly high risk for these reactions.

[July 17, 2008 - Information for Healthcare Professionals - FDA]
[June 2008 - Dear Healthcare Professional Letter - GE]
[May 2008 - Dear Healthcare Professional Letter - Lantheus Medical Imaging]

Previous MedWatch Alerts:

[10/12/2007]

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Electronic Medical Devices: Audience: Radiologists, surgeons, hospital risk managers, other healthcare professionals
[Posted 07/16/2008] FDA informed healthcare professionals of the possibility that x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. Most patients with electronic medical devices undergo CT scans without any adverse consequences. However, the Agency has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. FDA is continuing to investigate the issue and is working with the manufacturer to raise awareness in the healthcare community. See the FDA Public Health Notification for a description of adverse event reports and recommendations regarding reducing the potential risk to patients.

[July 14, 2008 - Public Health Notification - FDA]
: Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Sodium Polystyrene Sulfonate Suspension: Audience: Pharmacists, hospital risk managers, other healthcare professionals
[Posted 07/16/2008] Roxane Laboratories, Inc. informed healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; lot 856396A Exp April 2010, and lot 856693A Exp May 2010), a product used to treat hyperkalemia. A sample of one of the affected lots tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Symptoms of a yeast infection range from thrush, skin rash, and blood infections. If patients develop an infection they should consult their physician. Pharmacists should determine if any of the referenced product has been dispensed and retrieve it. Additionally, pharmacists and wholesalers of the product should discontinue distribution and use of the referenced lots immediately and contact the manufacturer regarding returning the product.

[July 14, 2008 - Recall - Roxane Laboratories, Inc.]; Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Avastin (bevacizumab): Audience: Oncologists, other healthcare professionals
[Posted 07/14/2008] Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. Avastin is not approved for use in combination with sunitinib malate and this combination is not recommended. Twenty-five patients were enrolled in a Phase I dose-escalation study combining Avastin and sunitinib malate. The study consisted of 3 cohorts using a fixed dose of Avastin at 10mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels, and severe hypertension, reversible posterior leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Healthcare professionals should report cases of MAHA or any serious adverse events suspected to be associated with the use of Avastin.

[July 11, 2008 - Dear Healthcare Pr

2008 Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics)

How to Find a Safety Summary

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Special Nutritional Products and Cosmetics:

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Medical Devices:

2008 Safety Alerts for Human Medical Products
(Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics)