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Insulin Glargine Potentially Associated With Increased Cancer Risk
The increased risk has been seen in 3 of 4 observational studies, but these findings warrant further follow-up studies to confirm an association, according to the FDA.
News, July 2009
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Chantix and Zyban to Receive Boxed Warnings for Serious Neuropsychiatric Symptoms
Varenicline and bupropion are receiving boxed warnings regarding the risks for changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.
News, July 2009
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Ongoing Analyses Suggest Cefepime Does Not Increase Death Risk
In contrast to previous findings, cefepime does not appear to increase the mortality risk compared with other similar antibiotics; manufacturer and FDA studies to investigate this issue are ongoing.
News, June 2009
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FDA Urges Caution in Interpreting Study Linking Stimulants to Increased Risk for Sudden Death in Children
A case-control study finds that methylphenidate is associated with a 6- to 7-times increased risk for sudden death in children; the FDA cautions that the study should not be used to stop these medications.
News, June 2009
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FDA Warns of Increased Mortality Risk for Sirolimus in Liver Transplantation
The FDA has issued a safety alert warning of an increased mortality risk in once-stable liver transplant patients who are converted from a CNI-based immunosuppressive regimen to sirolimus.
News, June 2009
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Propylthiouracil Linked With Risk for Serious Liver Damage, Death
The FDA has issued a safety alert about the risk for serious liver damage, including liver failure, or death with propylthiouracil compared with methimazole.
News, June 2009
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FDA Issues Reminder on Risk for Serious Fungal Infections With TNF-alpha Blockers, Including Simponi
The FDA has released a safety warning on the risk of serious fungal infections associated with golimumab and other tumor necrosis factor-alpha inhibitors.
News, May 2009
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FDA Recalls Respironics Infant Apnea Monitors
A class I recall of the Respironics SmartMonitor 2 Infant Apnea Monitor, models 4002 and 4003, has been announced by the US Food and Drug Administration.
News, May 2009
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Tarceva Gets Safety Warnings for Potentially Fatal GI Perforation, Other Disorders
The FDA has added safety information about 3 disorders to erlotinib's labeling: gastrointestinal perforation; bullous, blistering, and exfoliative skin conditions; and ocular disorders.
News, May 2009
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New Boxed Warning for Testosterone Gels to Protect Against Secondary Exposure
The FDA is requiring a boxed warning to be added to testosterone gel product labeling after reports of premature development of secondary sex characteristics in young children in close contact with users of the products.
News, May 2009
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FDA Approves New Labeling for All Antiepileptics to Reflect Suicidality Risk
The US Food and Drug Administration announced that it will require manufacturers of all antiepileptic drugs to include a warning in their labeling about an increased risk for suicidality with these agents and to develop a medication guide to provide information on this risk to patients who are prescribed these drugs.
News, May 2009
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FDA Warns About Disetronic Insulin Pump Failure
The FDA has alerted healthcare providers about a defect in the "up" and/or "down" buttons of Accu-Chek Spirit insulin pumps.
News, May 2009
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FDA to Require Boxed Warning for Botulinum Toxin Products
The FDA today notified manufacturers of botulinum toxin products of the need to add a boxed warning about the risk of adverse events when the effects of the toxin spread beyond the injection site.
News, April 2009
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Ceftriaxone Can Be Administered With Calcium-Containing Products in Certain Patients
Ceftriaxone can now be administered concomitantly with calcium-containing products in patients older than 28 days, updating a previous recommendation contraindicating this combination in all age groups.
News, April 2009
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Efalizumab Withdrawn From US Market
Efalizumab (Raptiva), used for the treatment of psoriasis, will no longer be available in the United States because of the risk for progressive multifocal leukoencephalopathy.
News, April 2009
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Cerebral Ventricular Catheter Recalled
The FDA and Medtronic have issued a class 1 recall for ventricular catheters that can become detached and may require emergency corrective surgery.
News, March 2009
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FDA Warns Against Sharing Single-Use Insulin Pens, Cartridges
Insulin pens and cartridges should not be used in multiple patients because of the risk for transmission of blood-borne pathogens.
News, March 2009
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Recall Issued on Baxter Electronic Infusion Pumps
The FDA reports a class 1 recall on Baxter Colleague infusion pumps because of software and battery usage failures that could result in interruption of therapy, damaged battery messages, smoke and fire hazards, and serious injury and/or death.
News, March 2009
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Recall Issued on Pediatric Tracheostomy Tube Parts
The FDA announces a class 1 recall on Shiley 3.0PED Cuffless Pediatric Tracheostomy Tubes
News, March 2009
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Medicated Patch Can Cause Burns During MRI, FDA Warns
Certain transdermal patches containing even small traces of aluminum or other metals in the adhesive backing can cause skin burns if worn during magnetic resonance imaging.
News, March 2009
