Safety Alerts & Recalls

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Follow-up to the FDA's Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia)
The FDA has concluded its safety review of the possible association between the use of Vytorin and an increased risk of cancer and cancer-related death compared to placebo. Vytorin is a combination of two medications, simvastatin (Zocor) and ezetimibe (Zetia), and is used to lower cholesterol. The review was first announced in August 2008 as part of an FDA Early Communication prompted by early results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. The FDA has now completed its review of the data from the SEAS trial as well as a review of available data from two large-scale ongoing cardiovascular trials with Vytorin - the SHARP and IMPROVE-IT trials. Based on the currently available information, the FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm194964.htm
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Follow-up to the FDA's Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia)
The FDA has concluded its safety review of the possible association between the use of Vytorin and an increased risk of cancer and cancer-related death compared to placebo. Vytorin is a combination of two medications, simvastatin (Zocor) and ezetimibe (Zetia), and is used to lower cholesterol. The review was first announced in August 2008 as part of an FDA Early Communication prompted by early results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. The FDA has now completed its review of the data from the SEAS trial as well as a review of available data from two large-scale ongoing cardiovascular trials with Vytorin - the SHARP and IMPROVE-IT trials. Based on the currently available information, the FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm194964.htm
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Date Published Title Drug Source
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
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
2009-12-23 Voluntary Recall of 4.7 million Doses of Medimmune H1N1 Nasal Spray Vaccine Influenza A (H1N1) Vaccine Manufacturer
2009-12-29 Voluntary Recall of All Lots of Tylenol Arthritis Pain Caplet 100 Count Bottles Acetaminophen Manufacturer
2010-01-07 Recall of Several Lots of Milk of Magnesia Cherry Liquid 12 ounce Bottles FDA
2010-01-15 Follow-Up to the FDA Safety Review of Tiotropium (marketed as Spiriva Handihaler) Tiotropium FDA
2010-01-15 Updated Information on Monitoring of Rapamune (Sirolimus) Drug Levels Sirolimus FDA
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Acetaminophen Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Acetaminophen with Diphenhydramine Hydrochloride Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Diphenhydramine Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Calcium Carbonate with Magnesium Hydroxide Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Rolaids Multi-Symptom Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Aspirin Manufacturer
2010-01-18 FDA Warns Consumers About Counterfeit Alli Orlistat FDA
2010-01-20 Endo Discontinues Making Moban (molindone hydrochloride) Moban Manufacturer
2010-01-21 Follow Up to FDA Ongoing Safety Review of SIBUTRAMINE, Marketed as MERIDIA Sibutramine FDA
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Detemir Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Lispro Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Aspart Manufacturer