-
- Fraudulent Avian Flu Therapies
- Audience: Consumers and all healthcare professionals
[Posted 12/29/2005] FDA notified healthcare professionals and patients that it issued warning letters to nine companies marketing bogus flu products behind claims that their products could be effective against preventing the avian flu or other forms of influenza. FDA is not aware of any scientific evidence that demonstrates the safety or effectiveness of these products for treating or preventing avian flu and the agency is concerned that the use of these products could harm consumers or interfere with conventional treatments.
[December 13, 2005 - Press Release - FDA]
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-
- Endologix Powerlink System Delivery Catheters
- Audience: Vascular surgery healthcare professionals, OR managers, and hospital risk managers
[Posted 12/20/2005]
Endologix and FDA notified healthcare professionals of the voluntary product recall of selected Powerlink System delivery catheters marketed in the U.S., used to deliver minimally invasive treatment for abdominal aortic aneurysms. Endologix initiated the recall as a result of an analysis of three recent reports of tip separation from the catheter sheath inner core during procedures. This action does not include the Powerlink stent grafts that have been implanted in patients or the large diameter 34 mm Powerlink System being evaluated under an investigational device exemption or Powerlink Systems sold outside of the U.S.
[December 14, 2005 - Press Release - Endologix]
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- Baxter Meridian Hemodialyis (HD) Instrument
- Audience: Hemodialysis administrators, nephrologists and other healthcare professionals
[Posted 12/14/2005]
The FDA has classified Baxter Healthcare Corporation's Meridian Hemodialyis (HD) Instrument (Product Codes 5M5576 and 5M5576R) as a Class I recall. There have been reports of hemolysis related to kinks in the blood tubing sets used with the Meridian. To date, there have been reports of one death and at least one serious injury, associated with kinking of blood tubing sets routed through both channels of the clips mounted on the front of the Meridian.
This classification does not require the return of Meridian instruments currently in the market. In the September 28, 2005 letter, Baxter directs customers to route blood tubing through only one channel of the two channel clips mounted on the front of the Meridian to reduce the risk of blood tubing kinks.
Baxter also provided labels with the September 28, 2005, customer letter to be affixed to Meridian instruments. The labels clearly display the proper routing of the blood tubing sets. Further, Baxter asks that all care providers be trained on this procedure. In addition, Baxter will be providing modified tubing clips to eliminate related safety issues as soon as possible.
[December 13, 2005 - Press Release - Baxter Healthcare]
[December 19, 2005 - Recall Notice - FDA]
[September 28, 2005 - Firm Recall Notice - Baxter Healthcare] ![Adobe Acrobat [pdf] file](../../IMAGES/PDF.GIF)
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- Methotrexate for Injection (preservative free)
- Audience: Oncologists, dermatologists, rheumatologists, and other healthcare professionals
[Posted 12/13/2005]
FDA and Bedford Laboratories, a division of Ben Venue Laboratories, Inc., Bedford, Ohio, announced that it is voluntarily recalling one lot of Methotrexate for Injection (preservative free), USP 1 gram per vial (NDC 55390-143-01), Lot # 859142, exp 09/07, because the active drug substance (“ADS”) used to manufacture Lot # 859142, contained low levels of ethylene glycol. Preservative-free methotrexate is the only formulation that is acceptable for intrathecal administration. Healthcare professionals and suppliers should not distribute these vials and should contact Bedford Laboratories for return instructions. Consumers that have received this product and have questions should contact their physicians.
[December 8, 2005 - Press Release - Bedford Laboratories]
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- Paroxetine HCl - Paxil and generic paroxetine
- Audience: Neuropsychiatric and other healthcare professionals
[Posted 12/08/2005]
The FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA’s request, the manufacturer has changed paroxetine’s pregnancy category from C to D and added new data and recommendations to the WARNINGS section of paroxetine’s prescribing information. FDA is awaiting the final results of the recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine.
Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it. Women should not stop the drug without discussing the best way to do that with their physician.
[December 8, 2005 - Public Health Advisory - FDA]
[December 7, 2005 - Healthcare Professional Information Sheet [PDF] [HTML] - FDA]
[December 7, 2005 - Patient Information Sheet [PDF] [HTML] - FDA]
[December 2005 - Dear Healthcare Professional Letter - GSK]
[December 2005 - Paxil Label - GSK]
[December 2005 - Paxil CR Label - GSK]
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- Miracle II Neutralizer and Miracle II Neutralizer Gel by Tedco Inc.
- Audience: Healthcare professionals and consumers
[Posted 12/06/2005]
The FDA advised consumers not to use Miracle II Neutralizer and Miracle II Neutralizer Gel products manufactured by Tedco, Inc., in West Monroe, Louisiana because the products are bacterially contaminated and have not been proven to be safe and effective. Use of these products could pose a risk of serious adverse events such as infections, particularly in children, the elderly, and individuals with weakened immune systems who are particularly susceptible to illness.
A number of stores sell Miracle II Neutralizer and Miracle II Neutralizer Gel, and the products are distributed and sold worldwide and sold via the Internet. The products are packaged in 8 oz, 22 oz, and one-gallon size containers.
[December 06, 2005 - News Release - FDA]
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- Boston Scientific Stainless Steel Greenfield Vena Cava Filters
- Audience: Cardiologists and other healthcare professionals
[UPDATE 01/13/2006] Recall classified as Class 1 recall by FDA.
[Posted 12/06/2005]
Boston Scientific Corporation announced that it is voluntarily recalling all Stainless Steel Greenfield Vena Cava Filters with 12Fr Femoral Introducer Systems manufactured before March 10, 2004. All unused devices with a "use before date" prior to March 2007 are to be returned to Boston Scientific (product code M001505010). The total number of devices involved in this recall is estimated at 18,000. There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the filter's delivery system during the implant procedure. If the carrier capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization. Potential adverse events include serious patient injury or death. This recall does not affect vena cava filters that have been implanted in patients.
UPDATE: January 13, 2005 - Recall Notice - FDA
[December 02, 2005 - Press Release - Boston Scientific Corporation]
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- NeutroSpec (Technetium [99m Tc] fanolesomab)
- Audience: Medical imaging specialists, hospital administrators and risk managers
[UPDATE Posted 12/19/2005]
FDA issued a Public Health Advisory to alert patients and health care providers that Palatin Technologies Inc. and Mallinckrodt have agreed to implement an immediate voluntary market suspension due to serious safety concerns, making NeutroSpec unavailable for approved or investigational uses. FDA urges health care providers to discontinue use of existing stocks of NeutroSpec and to contact Palatin Technologies regarding their return. FDA is conducting further investigation into the deaths and adverse events associated with NeutroSpec and is working closely with the manufacturers of the product to evaluate the risks and benefits associated with its use.
[Posted 12/02/2005]
Mallinckrodt, Palatin Technologies and FDA notified healthcare professionals of postmarketing reports of serious and life-threatening cardiopulmonary events following the administration of NeutroSpec [Technetium (99m Tc) fanolesomab], a radiodiagnostic agent consisting of a murine IgM monoclonal antibody formulated to be labeled with technetium, indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older.
Onset of these events generally occurred within minutes of injection and included two deaths attributed to cardiopulmonary failure within 30 minutes of injection. Additional cases of serious cardiopulmonary events including cardiac arrest, hypoxia, dyspnea and hypotension required resuscitation with fluids, vasopressors, and oxygen.
Any patient who receives NeutroSpec should be closely monitored for at least one hour following product administration. Resuscitation equipment and appropriately trained personnel must be readily available during this time. Patients with underlying cardiopulmonary conditions may be
at higher risk for serious complication. NeutroSpec administration to these patients should only follow careful consideration of the known and potential risks and benefits, including the possibly higher risks.
[December 19, 2005 - Public Health Advisory - FDA]
[December 19, 2005 - Drug Information Page - FDA]
[November 30, 2005 - Letter - Mallinckrodt/Palatin]
[July 2004 - Label - Mallinckrodt/Palatin]
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- Aranesp (darbepoetin alfa)
- Audience: Hematology/Oncology, Nephrology and other healthcare professionals
[Posted 12/01/2005]
Amgen and FDA notified healthcare professionals of revision to the WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Aranesp. The revised labeling provides updated safety information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with Aranesp. This has been reported predominantly in patients with CRF receiving Aranesp by subcutaneous administration. Recommendations for evaluation and treatment are provided in the new prescribing information.
[November 2005 - Aranesp Letter - Amgen]
[October 2005 - Aranesp Label - Amgen]
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- Epogen (epoetin alfa)
Procrit (epoetin alfa)
- Audience: Hematology/Oncology, Nephrology and other healthcare professionals
[Posted 12/01/2005]
Amgen, Ortho Biotech and FDA notified healthcare professionals of revision to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Epogen and Procrit. The revised labeling provides updated safety information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with these products. This has been reported predominantly in patients with CRF receiving these products by subcutaneous administration. Recommendations for evaluation and treatment are provided in the new prescribing information.
[November 2005 - Epogen Letter - Amgen]
[October 2005 - Epogen Label - Amgen]
[November 2005 - Procrit Letter - Ortho Biotech]
[October 2005 - Procrit Label - Ortho Biotech]
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- NovoSeven Coagulation Factor VIIa (Recombinant)
- Audience: Hematological and other healthcare professionals
[Posted 12/01/2005]
Novo Nordisk and FDA notified healthcare professionals of revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for NovoSeven, to provide updated safety information on thrombotic and thromboembolic adverse events, based on clinical studies in non-hemophilia patients and on post-marketing safety surveillance. A clinical study in elderly, non-hemophiliac, intracerebral hemorrhage patients indicated a potential increased risk of arterial thromboembolic adverse events with use of NovoSeven, including myocardial ischemia, myocardial infarction, cerebral ischemia and/or infarction.
[November 23, 2005 - Letter - Novo Nordisk]
[October 2005 - Label - Novo Nordisk]
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- MBI Distributing, Inc. [Molecular Biologics] Over-The-Counter Eye Drops and Pain-Relieving Drugs
- Audience: Consumers, caregivers and healthcare professionals
[Posted 11/30/2005]
FDA notified consumers, caregivers, and healthcare professionals that MBI Distributing, Inc. (MBI), also known as Molecular Biologics, an over-the-counter [OTC] drug manufacturer of eye drops and other products will cease manufacturing and distributing drugs until it corrects manufacturing deficiencies and other violations. MBI's product line includes eye drops sold under the brand names Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C, as well as several OTC pain relieving drugs. These products are sold by retailers nationwide.
FDA determined that the firm lacked manufacturing controls to ensure that its eye drops were sterile. FDA has also determined that two of the firm's eye drop brands, Visitein and Clarity Vision for Life, are unapproved drugs. In addition, three of the firm's OTC pain relieving drugs, Biogesic, Bio-Ice, and Bio-Heat, do not provide adequate warnings for their safe use. FDA recommends that consumers, health care providers, and caregivers dispose of the Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C brands of eye drops and the Biogesic, Bio-Ice, and Bio-Heat pain relieving drugs.
[November 29, 2005 - News Release - FDA]
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- Flomax (tamsulosin HCl)
- Audience: Ophthalmologists, Urologists, and other healthcare professionals
[Posted 11/22/2005]
Boehringer Ingelheim and FDA notified healthcare professionals of revisions to PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information for Flomax, indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). A surgical condition termed Intraoperative Floppy Iris Syndrome (IFIS) has been observed during phacoemulsification cataract surgery in some patients treated with alpha-1 blockers including Flomax. Most of these reports were in patients taking the alpha-1 blocker when IFIS occurred, but in some cases alpha-1 blocker had been stopped prior to surgery. It is recommended that male patients being considered for cataract surgery, as part of their medical history, be specifically questioned to ascertain whether they have taken Flomax or other alpha-1 blockers. If so, the patient's ophthalmologist should be prepared for possible modifications to their surgical technique that may be warranted should IFIS be observed during the procedure.
[November 2005 - Letter - Boehringer Ingelheim]
[October 5, 2005 - Label - Boehringer Ingelheim]
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- GenTeal Gel and GenTeal GelDrops
- Audience: Ophthalmologists, other healthcare professionals and consumers
[Posted 11/22/2005]
Novartis Ophthalmics and FDA notified healthcare professionals and patients of a voluntary recall due to a lack of sterility assurance of seven lots of two products, GenTeal Gel and GenTeal GelDrops, intended for use to relieve dryness of the eye. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people.
The five lots of GenTeal Gel include about 142,500 tubes that were distributed nationwide from March to November 2004.
The two lots of GenTeal GelDrops include about 12,000 dropper bottles that were distributed nationwide in October 2005.
Test results for GenTeal Gel indicated the presence of mold in a small number of samples, leading Novartis to initiate a recall of the five lots. The species of mold that is suspected is generally not harmful, but has the potential to cause an eye infection in susceptible people, especially in those with compromised immune systems.
[November 16, 2005 - Press Release - Novartis]
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- Long-acting Beta2-Adrenergic Agonists:
Advair Diskus (fluticasone propionate & salmeterol inhalation powder)
Foradil Aerolizer (formoterol fumarate inhalation powder)
Serevent Diskus (salmeterol xinafoate inhalation powder)
- Audience: Pulmonologists, other healthcare professionals and consumers
[Posted 11/18/2005] FDA notified manufacturers of Advair Diskus, Foradil Aerolizer, and Serevent Diskus to update their existing product labels with new warnings and a Medication Guide for patients to alert health care professionals and patients that these medicines may increase the chance of severe asthma episodes, and death when those episodes occur. All of these products contain long-acting beta2-adrenergic agonists (LABA). Even though LABAs decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur. A Medication Guide with information about these risks will be given to patients when a prescription for a LABA is filled or refilled.
[November 18, 2005 - Public Health Advisory - FDA]
[November 18, 2005 - Drug Information Page - FDA]
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- Diabetisource AC
- Audience: Healthcare institutional administrators, healthcare professionals and consumers
[Posted 11/17/2005] FDA and Novartis Nutrition Corporation notified healthcare professionals of a recall of 2,712 bottles of an enteral feeding formula that was incorrectly labeled as Diabetisource AC 1.5 Liter bottles lot 2135L. The affected product was shipped nationwide and is only distributed to healthcare institutional facilities. The bottles contain sodium and calcium caseinate, components of milk. People with an allergy or severe sensitivity to milk may run the risk of a serious or life threatening allergic reaction if they consume this product. Healthcare professionals administering Diabetisource AC to patients who have an allergy or sensitivity to milk should immediately stop using this product.
[November 17, 2005 - Recall Notice - Novartis]
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- Risk of Electromagnetic Interference with Medical Telemetry Systems Operating in the 460-470 MHz Frequency Bands
- Audience: Healthcare risk managers and healthcare professionals
[Posted 11/16/2005]
FDA issued a Public Health Notification regarding increased risk for electromagnetic interference in any medical telemetry systems operating in the
460-470 MHz frequency bands after December 31, 2005. This interference could compromise
patient safety. In January 2006 the Federal Communications Commission will begin issuing
new licenses for mobile radio transmitters to operate in the 460-470 MHz band.
According to tests conducted by the FDA, the transmitters operating under new licenses in
this frequency band can interfere with medical telemetry systems. This could lead to lapses in patient monitoring and missed alarm events, putting patients at risk. The anticipated interference will not be limited to urban areas. Any medical facility in the vicinity of a mobile radio could be affected.
[November 16, 2005 - Public Health Notification - FDA]
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- Ortho Evra (norelgestromin/ethinyl estradiol transdermal system)
- Audience: Reproductive and other healthcare professionals, and consumers
[Posted 11/14/2005]
FDA notified healthcare professionals and patients of revisions to the label for Ortho Evra, a skin patch approved for birth control, that includes a bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 micrograms of estrogen. A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.
[November 10, 2005 - News Release - FDA]
[November 10, 2005 - Drug Information Page - FDA]
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- Amevive (alefacept)
- Audience: Dermatologists and other healthcare professionals
[Posted 11/10/2005]
Biogen Idec and FDA notified healthcare professionals of revisions to CONTRAINDICATIONS section of the prescribing information for Amevive, indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Amevive should not be administered to patients infected with HIV. Amevive reduces CD4+ T lymphocyte counts, which might accelerate disease progression or increase complications of disease in these patients. In addition, other sections of the product labeling were revised to reflect additional safety information.
[October 2005 - Letter - Biogen Idec]
[September 2005 - Label - Biogen Idec]
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- Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products
- Audience: Endocrinologists and other healthcare professionals, clinical laboratory managers, risk managers and patients
[UPDATE 04/22/2008] Fatal Iatrogenic Hypoglycemia: falsely elevated blood glucose readings with a point-of-care meter due to a maltose-containing intravenous immune globulin product. Following receipt of the index case, FDA conducted an investigation. This review represents the final report of that investigation.
[Posted 11/10/2005] FDA notified physicians, nurses, medical technologists, pharmacists and other healthcare professionals of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose, and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. There have been reports of the inappropriate administration of insulin and consequent life-threatening/fatal hypoglycemia in response to erroneous test results obtained from patients receiving parenteral products containing maltose. Cases of true hypoglycemia can go untreated if the hypoglycemic state is masked by false elevation of glucose readings. A preliminary listing of U.S. products that may cause glucose test interference is provided.
[April 17, 2008 - Final Report - FDA/CBER/CDRH]
[November 09, 2005 -
Important Safety Information
- FDA/CBER]
[November 09, 2005 -
Reminder Notice - FDA/CDRH]
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- Avinza
(morphine sulfate extended-release capsules)
- Audience: Pain specialists, other healthcare professionals and
consumers
[Posted 11/03/2005] Ligand Pharmaceuticals Inc. and FDA notified healthcare professionals of revisions to
BOXED WARNING, WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY, and DOSAGE AND ADMINISTRATION sections
of the prescribing information to highlight and strengthen the warning that patients should not
consume alcohol while taking Avinza. Additionally, patients must not use prescription or
non-prescription medications containing alcohol while on Avinza therapy.
[October 2005 -
Letter - Ligand Pharmaceuticals Inc.]
[October 2005 -
Label - Ligand
Pharmaceuticals Inc.]
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-
- Omron 3-Way Instant Thermometers
- Audience: Consumers and Pharmacists
[Posted 11/02/2005] Omron Healthcare Inc. initiated a voluntary recall of certain Omron® 3-Way Instant Thermometers – model numbers MC-600 and MC-600CAN – due to overheating of the tip. Omron had received consumer complaints indicating discomfort during and following use of the thermometers. Consumers who continue using the affected thermometers are at risk of discomfort during use, potentially resulting in redness or even a blister on the skin. Very young children using this device are at an increased risk due to the inability to express themselves and to their difficulty in pulling away from the device held by an adult. The battery-operated, digital thermometers, available through drug stores, the pharmacy sections of food stores and mass merchandise chains, and internet retailers were sold in the United States and Canada between Sept. 19, 2001, and October 21, 2005.
[October 24, 2005 - Press Release - Omron Healthcare Inc.]
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-
- Salus Corporation Shampoo Caps
- Audience: Hospital and Extended Care Facility Risk Managers and supervisory personnel
[Posted 11/01/2005] Salus Corporation dba ICP Medical of Olivette, Missouri, has voluntarily initiated a nationwide recall of all lot numbers of shampoo caps with conditioner because some of the product is contaminated with the bacteria Serratia marcescens. Serratia marcescens has the potential to cause severe and life-threatening illness, especially in those with a compromised immune system. The shampoo caps were manufactured under three brand names: (1) The Salus Corporation dba ICP Medical brand name of CompleteBath (Reorder No. ICP095230); the brand name of ReadyBath, manufactured for Medline Industries, Inc., Mundelein, IL (Reorder No. MSC095230); and the brand name of No-Rinse, manufactured for No Rinse Laboratories, LLC, Centerville, OH (Reorder No. 02000). The shampoo caps were distributed to health care facilities and institutions nationwide through Salus Corporation, Medline Industries, and No Rinse Laboratories. The product can also be purchased through the internet.
[October 31, 2005 - Press Release - Salus Corporation]
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-
- Zevalin (ibritumomab tiuxetan)
- Audience: Hemato-oncologists and other healthcare professionals
[Posted 10/28/2005] Biogen Idec and FDA notified healthcare professionals of revision to BOXED WARNINGS, WARNINGS, and ADVERSE REACTIONS sections of the Prescribing Information to describe severe cutaneous or mucocutaneous reactions, some with fatal outcome, that have been reported in association with the Zevalin therapeutic regimen in the post-marketing experience. Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the Zevalin therapeutic regimen and should seek prompt medical evaluation.
[October 2005 - Letter - Biogen]
[September 2005 - Label - Biogen]
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-
- Vapotherm 2000i Respiratory Gas Administration Device
- Audience: Neonatologists, Respiratory healthcare professionals and hospital clinical managers
[UPDATE posted 12/20/2005] See update of safety information about Ralstonia spp. associated with Vapotherm Respiratory Gas Administration Device. The FDA continues to collaborate with the CDC to determine the scope of the contamination with Ralstonia spp., and other opportunistic pathogens. Further information is proved in the updated MMWR from CDC.
[Posted 10/27/2005]
FDA issued a Preliminary Public Health Notification to inform healthcare professionals of new information about a possible association between the Vapotherm 2000i Respiratory Gas Administration device, used to add moisture and warm breathing gases through a nasal canula in patients receiving supplemental oxygen, and the occurrence of positive Ralstonia spp. cultures. The association was first reported in a MMWR article issued by CDC on October 21, 2005. The new information is described in the web notice at the link below. FDA recommends that providers consider this new information in deciding whether and when to use the Vapotherm device with patients.
[December 20, 2005 - Update: Preliminary Public Health Notification - FDA]
[December 20, 2005 - Morbidity and Mortality Weekly Report - CDC]
[October 27, 2005 - Preliminary Public Health Notification - FDA]
[October 19, 2005 - Morbidity and Mortality Weekly Report - CDC]
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-
- Abbott Diabetes Care Blood Glucose Meters
- Audience: All healthcare professionals and consumers
[UPDATE 11/04/2005] Class I recall posted.
[Posted 10/27/2005] FDA notified health care providers and patients of a problem with blood glucose meters made by Abbott Diabetes Care, Alameda, Calif. The meters can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate blood glucose interpretation by the user. Users in the United States should make sure that their meter reading is displayed as mg/dL because an inaccurate reading can lead to taking the wrong dose of insulin or dietary changes, resulting in higher levels of sugar in the blood or hyperglycemia. Hyperglycemia can be a serious and even life-threatening condition and several cases of hyperglycemia have been reported to FDA.
[November 04, 2005 - Recall Notice - FDA]
[October 26, 2005 - News Release - FDA]
Previous Related MedWatch alerts:
May 17, 2005 - LifeScan, Inc. OneTouch Ultra, InDuo and OneTouch FastTake Blood Glucose Meters
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-
- Cylert and generic pemoline products
- Audience: Neuropsychiatric healthcare professionals, Pediatricians, Pharmacists and consumers
[Posted 10/24/2005] FDA has concluded that the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug. In May 2005, Abbott chose to stop sales and marketing of Cylert in the U.S. All generic companies have also agreed to stop sales and marketing of this product. Cylert, a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), is considered second line therapy for ADHD because of its association with life threatening hepatic failure. Health care professionals who prescribe Cylert, or any of its generics, should transition their patients to an alternative therapy. Cylert will remain available through pharmacies and wholesalers until supplies are exhausted. No additional product will be available.
[October 24, 2005 - Drug Information page - FDA]
[December 2002 - Label - FDA]
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-
- Cymbalta (duloxetine hydrochloride)
- Audience: Neuropsychiatric and other healthcare professionals
[Posted 10/17/2005] Eli Lilly and FDA notified healthcare professionals of revision to the PRECAUTIONS/Hepatotoxicity section of the prescribing information for Cymbalta (duloxetine hydrochloride), indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain. Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with preexisting liver disease who take
duloxetine may have an increased risk for further liver damage. The new labeling
extends the Precaution against using Cymbalta in patients with substantial alcohol use to
include those patients with chronic liver disease.
It is recommended that Cymbalta not be administered to patients with any hepatic insufficiency.
[October 05, 2005 - Letter - Eli Lilly]
[September 2005 - Label - Eli Lilly]
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-
- Boston Scientific ENTERYX Procedure Kits and Injector Single Packs
- Audience: Surgeons, Gastroenterologists, other healthcare professionals, and patients
[Posted 10/17/2005] FDA and Boston Scientific notified healthcare professionals and patients about serious adverse events, including death, occurring in patients treated with ENTERYX, a liquid chemical polymer which is intended to be injected into the lower esophageal sphincter for treatment of gastroesophageal reflux disease. The serious adverse events involve unrecognized transmural injections of ENTERYX into structures surrounding the esophagus. On September 23, 2005, Boston Scientific issued a recall of all ENTERYX Procedure Kits and ENTERYX Injector Single Packs from commercial distribution. Physicians should stop injecting ENTERYX immediately and follow the manufacturer’s procedures for returning unused product. FDA also provided recommendations on avoiding future occurrences and advice for patients.
[October 14, 2005 - Preliminary Public Health Notification - FDA]
[October 17, 2005 - Advice for Patients - FDA]
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-
- Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135)
- Audience: Neurological and other Healthcare Professionals, and Consumers
[Posted 10/03/2005] FDA and CDC notified consumers and health care providers of five reports of Guillain Barre Syndrome following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra), manufactured by Sanofi Pasteur. It is not known yet whether these cases were caused by the vaccine or are coincidental. FDA and CDC are sharing this information with the public now and actively investigating the situation because of its potentially serious nature. Guillain Barre Syndrome (GBS) is a serious neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in the legs and arms that can be severe and require hospitalization. Because of the potentially serious nature of this matter, FDA and CDC are asking any persons with knowledge of any possible cases of GBS occurring after Menactra to report them to the Vaccine Adverse Event Reporting System (VAERS) to help the agencies further evaluate the matter.
[September 30, 2005 - News Release - FDA]
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-
- Strattera (atomoxetine)
- Audience: Neuropsychiatric and other Healthcare Professionals, and Consumers
[Posted 09/29/2005] The FDA directed Eli Lilly and Company (Lilly), the manufacturer of Strattera (atomoxetine), to revise the prescribing information to include a boxed warning and additional warning statements that alert health care providers of an increased risk of suicidal thinking in children and adolescents being treated with this medication. FDA also informed Lilly that a Patient Medication Guide (MedGuide) should be provided to patients when Strattera is dispensed. The MedGuide advises patients of the risks associated with and precautions that can be taken when Strattera is dispensed. Further, pediatric patients being treated with Strattera should be closely observed for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
[September 29, 2005 - Public Health Advisory - FDA]
[September 29, 2005 - Press Release - FDA]
[September 29, 2005 - Drug Information Page - FDA]
[September 29, 2005 - Healthcare Professional Information Sheet [PDF] [HTML] - FDA]
[September 29, 2005 - Patient Information Sheet [PDF] [HTML] - FDA]
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- Fluorouracil Injection 50mg/mL, (500 mg/10mL Single Dose Vial)
- Audience: Oncologists, pharmacists, and other healthcare professionals
[Posted 09/27/2005] American Pharmaceutical Partners, Inc. and FDA notified healthcare professionals about a nationwide recall of Fluorouracil Injection 50 mg/mL (500 mg/10ml Single Dose Vial) because of the potential for invisible glass particles containing silica and aluminum in vials of the product. The company states that only Product code 101710 is susceptible to this type of glass breakdown.
[September 2005 - Recall Notice - FDA]
[September 2005 - Product Recall - American Pharmaceutical Partners, Inc.]
[September 2005 - Dear Healthcare Professional Letter - American Pharmaceutical Partners, Inc.]
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- Paxil (paroxetine HCL)
Paxil CR Controlled-Release Tablets
- Audience: Neuropsychiatric and other healthcare professionals
[Posted 09/27/2005] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Pregnancy/PRECAUTIONS section of the Prescribing Information for Paxil and Paxil CR Controlled-Release Tablets to describe the results of a GSK retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. This study suggested an increase in the risk of overall major congenital malformations for paroxetine as compared to other antidepressants [OR 2.2; 95% confidence interval, 1.34-3.63]. Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients.
[September 2005 - Dear Healthcare Professional letter - GlaxoSmithKline]
[September 2005 - Paxil Label - GlaxoSmithKline]
[September 2005 - Paxil CR Label - GlaxoSmithKline]
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Toprol-XL (metoprolol succinate) extended release tablets
Topamax (topiramate) tablets
Tegretol (carbamazepine)
Tegretol-XR (carbamazepine extended-release)
- Audience: All healthcare professionals
[UPDATE November 10, 2005] Letters from Novartis Pharmaceuticals Corporation added below
[UPDATE September 30, 2005] Letters from Ortho-McNeil Neurologics, Inc. added below
[Posted 09/26/2005] AstraZeneca and FDA notified healthcare professionals reports of medication dispensing or prescribing errors between Toprol-XL (metoprolol succinate) extended release tablets, indicated for the treatment of hypertension, long-term treatment of angina pectoris, and heart failure NYHA Class II or III, and Topamax (topiramate), a product of Ortho-McNeil Neurologics, Inc, indicated for the treatment of epilepsy and migraine prophylaxis. There have also been reports of medication errors involving confusion between Toprol-XL and Tegretol or Tegretol-XR (carbamazepine), products of Novartis Pharmaceuticals Corporation, indicated for the treatment of complex partial seizures, generalized tonic-clonic seizures, and trigeminal neuralgia. These reports include instances where Toprol-XL was incorrectly administered to patients instead of Topamax, Tegretol, or Tegretol-XR, and vice versa, some of them leading to adverse events.
[October 2005 - Dear Healthcare Professional Letter - Novartis]
[October 2005 - Dear Pharmacist Letter - Novartis]
[September 2005 - Dear Healthcare Professional Letter - Ortho-McNeil Neurologics, Inc.]
[September 2005 - Dear Pharmacist Letter - Ortho-McNeil Neurologics, Inc.]
[September 22, 2005 - Dear Healthcare Professional Letter - AstraZeneca]
[September 22, 2005 - Dear Pharmacist Letter - AstraZeneca]
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- Injectable Products made by Central Admixture Pharmacy Service
(CAPS) of Lanham, Maryland
- Audience: Audience - Hospital Risk Managers, Pharmacists and Nursing Supervisory Staff
FDA is notifying healthcare professionals and hospitals about a product recall involving all injectable products manufactured by Central Admixture Pharmacy Services, Inc. of Lanham, Maryland (CAPS) due to concerns regarding the sterility of these
injectable products. CAPS distributed the affected injectable products to hospitals in Maryland,
Delaware, Washington, D.C., and Virginia. Gram negative rods have been identified in two lots of
Cardioplegia solution manufactured by CAPS. Non-sterility of injectable products could represent
a serious hazard to health that could lead to life-threatening injuries and death.
The following products distributed up to September 16, 2005, are affected by this action:
- Cardioplegia solutions including: Cardioplegia,
Cold Cardioplegia, Warm Cardioplegia, Blood
Cardioplegia 1, Blood Cardioplegia 2, Cardioplegia
Base 1, Cardioplegia Base 2, Cardioplegia Base,
Cardioplegia Reperfusion, Cardioplegia High
Potassium, Cardioplegia Low Potassium, Cardioplegia
#1, Cardioplegia #2 Cardioplegia #3; Maintenance
Cardioplegia, Enriched Cardioplegia, Cardioplegia
Hot Shot, Cardioplegia Base Enriched
- Oxytocin injectable products including:
Oxytocin Infusion, Oxytocin 20 units, Oxytocin 30
units, Oxytocin D5 ½ NS, Oxytocin in Lactated
Ringers
- Promethazine
- Magnesium-containing injectable products
including: Magnesium 1 GM, Magnesium 2 GM,
Magnesium Sulfate 2 GM, Magnesium 4 GM,
Hydration-Magnesium in D5W, Magnesium Infusion,
Magnesium in Lactated Ringers
- Heparin Replacement
- Antibiotic Irrigation Bag and Bottle
- Bupivicaine 0.25 % and 0.5%, Pain Bags (Bupivicaine
0.25 %)
- Dialysate solutions including: Citrate
Dialysate, Heparin Dialysate, Pediatric Dialysate,
Hydration Dialysate #1, Hydration Dialysate #2,
CRRT Dialysate, CVVHD (Dialysate) 300, CVVHD (Dialysate)
342, CVVHD Pediatric Formula (Normocarb), CVVHD
Formalin #1, CVVHD Formalin #2, CVVHD Formalin #3,
CVVHD Non-Standard, CVVHD D5W, CVVHD ½ NS, CVVHD NS
- Total Parenteral Nutrition (TPN) products
including: TPN-Day, TPN-Day 1 Neonatal Stock
Solution
- Diltiazem (Cardizem)
- Norepinephrine (Levophed)
- Cefazolin
Although CAPS has directly notified known hospital customers of the recall, hospitals, physicians, and
health care workers are urged to examine their supplies for any CAPS of Lanham, MD injectable
products and immediately discontinue their use and quarantine the products.
[September 17, 2005 -
Recall Notice - CAPS of
Lanham, MD]
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- BioMerieux VeriCal Calibrator Set
- Audience: Laboratory supervisory personnel and healthcare professionals
[UPDATE 10/14/2005] Class I recall notice added below
[Posted 09/16/2005]
BioMerieux and FDA notified healthcare professionals of a recall of VeriCal Calibrator Set, used to calibrate the Prothrombin Time (PT) and Activated Partial Thromboplastin Times (APTT) on bioMerieux instrument platforms. This recall only impacts INR determinations derived from Prothrombin Tim (PT) results on the following instrument platforms: MDA Coag-A-Mate MTX and Coag-A-Mate MAX. The recall is due to the mis-assignment of ISI values associated with VeriCal use. These calibrated ISI values are currently provided on Simplastin HFT and Simplastin L product labeling. The VeriCal labeling currently contains PT time in seconds and is being revised to include ISI assignment for specified reagents. The product recall notice offers detailed recommendations for action by laboratory personnel using these products.
[November 14, 2005 - Recall Notice - FDA]
[August 31, 2005 - Recall Notice - BioMerieux Inc.]
Related MedWatch safety alert:
[May 16, 2005]
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- NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin])
NovoLog (insulin aspart [rDNA origin] injection)
- Audience: Pharmacists and other healthcare professionals
[Posted 09/14/2005] Novo Nordisk Incorporated and FDA notified pharmacists of an initiative implemented to help prevent dispensing errors. To facilitate the dispensing of the correct product, color branded labeling has been introduced for NovoLog Mix 70/30, a premixed insulin analog, and NovoLog, a rapid-acting insulin analog. The previous box for NovoLog Mix 70/30 was white with a blue band. The current packaging for NovoLog Mix 70/30 is very similar and remains white with a blue band. The packaging for NovoLog previously was also white with a blue band. The current packaging is now white with an orange band. It is important that all pharmacists carefully distinguish insulin formulations by name and NDC number when dispensing.
[August 26, 2005 - Letter - Novo Nordisk Inc.]
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- Erbitux (cetuximab)
- Audience: Oncologists and other healthcare professionals
[Posted 09/14/2005] ImClone Systems Incorporated, Bristol-Myers Squibb Company and the FDA notified healthcare professionals of changes to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Erbitux, indicated for the treatment of epidermal growth factor receptor (EGFR) expressing metastatic colorectal carcinoma. The WARNINGS and DOSAGE AND ADMINISTRATION sections have been revised to notify healthcare providers about specific recommendations on observation periods following Erbitux infusion. In addition, the PRECAUTIONS and ADVERSE REACTIONS sections have been revised to discuss results seen in Erbitux clinical trials regarding an increased incidence of hypomagnesemia and recommendations for electrolyte monitoring.
[September 13, 2005 - Letter - ImClone Systems Incorporated and Bristol-Myers Squibb Company]
[August 2005 - Label - ImClone Systems Incorporated and Bristol-Myers Squibb Company]
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- Herceptin (trastuzumab)
- Audience: Oncologists, cardiologists, and other healthcare professionals
[Posted 08/31/2005] Genentech and FDA notified healthcare professionals of updated cardiotoxicity information related to the use of Herceptin (trastuzumab), obtained from the National Surgical Adjuvant Breast and Bowel Project (NSABP) study (B-31), a randomized, Phase III trial that was conducted in 2043 women with operable, HER2 overexpressing breast cancer (IHC 3+ or FISH+). This study demonstrated a significant increase in cardiotoxicity in patients who were randomized to the Herceptin-containing arm as compared to patients who received chemotherapy alone.
Preliminary analysis of safety data from Study NSABP B-31 and the North Central Cancer Treatment Group (NCCTG) study (N9831) revealed a statistically significant increase in the 3-year cumulative incidence of New York Heart Association Class III and IV congestive heart failure and cardiac death observed in patients who received the Herceptin-containing regimen (4.1%) compared with control (0.8%). There were no cardiac deaths observed in patients who received the Herceptin-containing regimen and one cardiac death was observed in the control arm. Final analysis of the cardiac safety data collected in Studies NSABP B-31 and NCCTG N9831 is ongoing.
[August 2005 - Letter - Genentech]
[February 2005 - Label - Genentech]
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- Alcohol-Free Mouthwash and Hygiene Kits by Medline
- Audience: Risk managers and hospital and long term care nursing supervisory staff
[Posted 08/29/2005] Medline and FDA notified healthcare professionals about a nationwide recall of Alcohol-Free Mouthwash and Hygiene Kits containing mouthwash because of potential contamination with Burkholderia cepacia. People who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. The product was distributed to hospitals, medical centers, and long term care facilities nationwide. There is no known distribution through retail sales. The CDC has confirmed hospital illness associated with the use of the affected mouthwash in Texas and Florida.
[August 29, 2005 - Notice - FDA]
[August 29, 2005 - Firm Press Release - Medline]
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- Trypan Blue 0.06% Ophthalmic Solution
- Audience: Ophthalmologists, other healthcare professionals, and consumers
[Posted 08/29/2005] Custom RX Compounding Pharmacy and FDA notified ophthalmologists, other healthcare professionals, and consumers about a nationwide recall of Trypan Blue 0.06% Ophthalmic Solution, intended for use in the eyes during cataract surgery, because it may be contaminated with Pseudomonas aeruginosa, a bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. Custom Rx Pharmacy is asking that all unexpired syringes be collected and returned to the pharmacy. The product was distributed to hospitals and clinics in Maryland, Minnesota, Illinois, Nebraska, North Dakota, Michigan, the District of Columbia, and Pennsylvania. The recall includes, but may not be limited to the following lot numbers: 05042005:86@17, 05252005:36@13, 06282005:91@27, 08012005:63@24, and 08182005:43@17.
[August 26, 2005 - Press Release - FDA]
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- Prisma Continuous Renal Replacement System
- Audience: Nephrologists, other healthcare professionals and consumers
[UPDATE Posted 03/01/2006] The August 2005 Preliminary Public Health Notification was updated with additional safety information.
[Posted 08/19/2005] Gambro Dasco S.p.A notified healthcare professionals and consumers of a safety alert for the Prisma continuous renal replacement system (all catalog numbers). Gambro Dasco has become aware of several serious injuries and deaths resulting from excessive ultrafiltration (fluid being removed from the patient’s body). This problem can occur when the user does not address the cause of the “Incorrect Weight Change Detected” alarm. This alarm should never be overridden without first identifying and removing the cause of the alarm. The device remains appropriate for use when these directions are followed.
[February 27, 2006 - FDA Updated Public Health Notification - FDA]
[August 23, 2005 - Preliminary Public Health Notification - FDA]
[August 16, 2005 - Press Release - Gambro Dasco S.p.A.]
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- Isotretinoin - Accutane and generic isotretinoin
- Audience: Dermatological, other healthcare professionals and patients
[Posted 08/12/2005] FDA notified healthcare professionals and patients | |
