Safety Alerts & Recalls

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FDA Warns of Risk of Serious Skin Reactions with Onfi (Clobazam)
The U.S. Food and Drug Administration (FDA) is updating the prescribing information and the patient Medication Guide to warn the public that the anti-seizure medication Onfi (clobazam) can cause rare but serious skin reactions called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These skin reactions can result in permanent harm and death. Stevens-Johnson syndrome and toxic epidermal necrolysis can occur at any time during Onfi treatment. However, the chance of experiencing these skin reactions is greater during the first 8 weeks of treatment or when Onfi is stopped and then re-started. All cases of skin reactions reviewed by the FDA have lead to hospitalization; one case resulted in blindness, and one case resulted in death. Onfi is a benzodiazepine medication used in combination with other medicines to treat seizures associated with a severe form of epilepsy called Lennox-Gastaut Syndrome. Serious skin reactions have not generally been associated with other benzodiazepines. For more information, please visit: www.fda.gov/Drugs/DrugSafety/ucm377204.htm
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FDA Removes Some Prescribing and Dispensing Restrictions For Rosiglitazone-Containing Medicines, Including Avandia, Avandamet, and Avandaryl
The U.S. Food and Drug Administration (FDA) has determined that the latest data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and their generics, do not show an increased risk of heart attack compared to other type 2 diabetes medicines (metformin and sulfonylureas (such as glipizide and glyburide)). As a result, the FDA is removing certain prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. The FDA decision is based on their recent review of the results from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation conducted by the Duke University Clinical Research Institute (DCRI). The FDA continues to monitor the safety and effectiveness of drugs after they are approved to be sold to the general population. In the case of rosiglitazone medicines, previous data suggested a higher risk of heart attack and in 2010 a Risk Evaluation and Mitigation Strategy (REMS), called the Rosiglitazone REMS program, was implemented by the FDA. The REMS required special certification for healthcare providers who prescribed rosiglitazone and pharmacies who dispensed it. Additionally, only patients who were already taking rosiglitazone before the restrictions or new patients who could not use any other glucose-lowering medications were eligible to receive it. With the latest data review for rosiglitazone, the FDA’s concerns about the risks of rosiglitazone are reduced. The rosiglitazone REMS program requirements will be modified and the rosiglitazone prescribing information and the patient Medication Guide will be updated to include this new information. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm376389.htm
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Date Published Title Drug Source
2013-12-03 FDA Warns of Risk of Serious Skin Reactions with Onfi (Clobazam) Clobazam FDA
2013-11-27 FDA Removes Some Prescribing and Dispensing Restrictions For Rosiglitazone-Containing Medicines, Including Avandia, Avandamet, and Avandaryl Glimepiride and Rosiglitazone FDA
2013-11-21 FDA Warns About Risks of Lexiscan (Regadenoson) and Adenoscan (Adenosine) Adenosine FDA
2013-11-04 Perrigo Recalls Several Store Brands of Acetaminophen Infant Suspension Liquid Due to Potential Defect with the Oral Syringe Included in Packaging Acetaminophen FDA
2013-11-01 FDA Adds Black Box Warning and Updates Warnings for Anti-Seizure Medicine Potiga (Ezogabine) Ezogabine FDA
2013-11-01 FDA Asks Manufacturer to Stop Sales of Its Leukemia Drug Iclusig (Ponatinib) Ponatinib FDA
2013-10-25 FDA Works to Put Tighter Controls on Hydrocodone Combination Pain Killers Hydrocodone FDA
2013-10-25 FDA To Complete Phase-Out of Chlorofluorocarbon Inhalers Including Combivent Inhalation Aerosol and Maxair Autohaler. Maxair FDA
2013-10-18 Nephron Pharmaceuticals Announces Recall of Albuterol Sulfate Inhalation Solution, 0.083% Albuterol FDA
2013-10-14 FDA Warns of Increased Reports of Serious Blood Clots with Iclusig (Ponatinib) Ponatinib FDA
2013-09-30 New Boxed Warning for Anti-Cancer Drugs Arzerra (Ofatumumab) and Rituxan (Rituximab) Rituximab FDA
2013-09-30 Combo-Medicine Juvisync Production Discontinued Sitagliptin and Simvastatin FDA
2013-09-30 FDA Warns: Do Not Use Budesonide Nasal Irrigation from The Compounding Shop Budesonide Inhalation FDA
2013-09-30 FDA Adds New Boxed Warning, Warns of Increased Risk of Death with Tygacil (Tigecycline) Tigecycline FDA
2013-09-25 Changes to Duragesic (Fentanyl) Packaging to Reduce Risk of Accidental Exposure Fentanyl FDA
2013-08-30 Consumers Warned Not to Purchased Ortiga, an Unapproved Product Diclofenac FDA
2013-08-29 FDA Investigating Report of Progressive Multifocal Leukoencephalopathy (PML) in Patient Taking Gilenya (Fingolimod) Fingolimod FDA
2013-08-19 FDA Strengthens Neuropathy Warnings for Fluoroquinolone Class of Antibiotics Gemifloxacin FDA
2013-08-05 FDA Warns of Rare But Serious Skin Reaction with Acetaminophen FDA
2013-08-05 FDA Warns: Purity First’s Expands Recall and Now Includes Healthy Life Chemistry B-50, Vitamin C and Multi-Mineral Vitamin B Complex FDA