Safety Alerts & Recalls

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Suspected association with acute pancreatitis
The FDA has issued a warning today that exenatide, the key ingredient in Byetta, may increase the risk of developing acute pancreatitis. This advice was issued after the FDA received reports of acute pancreatitis that may have been linked to exenatide use. Acute pancreatitis is the sudden inflammation of the pancreas that may be mild or life threatening but that usually subsides. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084305.htm
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Update on potential for acute pancreatitis in patients using Byetta
Today the FDA issued an update on the reports of acute pancreatitis in patients taking Byetta, a medicine given by subcutaneous injection to help treat people with type 2 diabetes. Since the October 2007 alert, the FDA has received 6 additional reports of acute pancreatitis thought to be associated with Byetta use. Acute pancreatitis is the sudden inflammation of the pancreas that may be mild or life threatening but that usually subsides. Symptoms of pancreatitis include persistent severe abdominal pain that can radiate to the back and may be accompanied by nausea and vomiting. For more information please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124713.htm
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Date Published Title Drug Source
2007-10-16 Suspected association with acute pancreatitis Exenatide FDA
2008-08-18 Update on potential for acute pancreatitis in patients using Byetta Exenatide FDA
2009-11-03 Reports of Altered Kidney Function in Patients Using Byetta Exenatide FDA
2008-08-22 FDA Is Reviewing Results From a Recent Clinical Trial of Vytorin Ezetimibe FDA
2009-01-09 FDA Issues Final Review of ENHANCE Study Ezetimibe FDA
2009-12-23 Follow-up to the FDA's Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) Ezetimibe FDA
2008-01-27 Early communication regarding ongoing FDA review Ezetimibe with Simvastatin FDA
2008-07-23 Preliminary results from the SEAS trial Ezetimibe with Simvastatin FDA
2008-08-08 Combination use can lead to rare condition of muscle damage Ezetimibe with Simvastatin FDA
2008-08-22 FDA Is Reviewing Results From a Recent Clinical Trial of Vytorin Ezetimibe with Simvastatin FDA
2009-01-09 FDA Issues Final Review of ENHANCE Study Ezetimibe with Simvastatin FDA
2009-12-23 Follow-up to the FDA's Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) Ezetimibe with Simvastatin FDA
2013-04-29 Anti-Seizure Medicine Potiga (Ezogabine) Linked to Eye Problems and Blue Skin Discoloration Ezogabine FDA
2013-11-01 FDA Adds Black Box Warning and Updates Warnings for Anti-Seizure Medicine Potiga (Ezogabine) Ezogabine FDA
2012-10-31 Mylan Pharmaceuticals Recalls Single Lot of Famotidine Tablets, 20 mg Famotidine FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Felbamate FDA
2008-12-17 New FDA Warning on Seizure Medications Felbamate FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Felbamate FDA
2008-09-03 Statins plus fibrates increase risk of muscle problems Fenofibrate MediGuard CRT
2008-09-18 FDA Stops Imports of Ranbaxy Products Fenofibrate FDA
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