FDA announces new safety recommendations for high-dose simvastatin

The U.S. Food and Drug Administration today is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose–80 milligram (mg)–has been associated with an elevated risk of muscle injury or myopathy,...

FDA: DDS probiotic products seized

U.S. Marshals, at the request of the U.S. Food and Drug Administration, today seized probiotic products from UAS Laboratories, Inc., of Eden Prairie, Minn. because the company markets the products as drugs.

FDA statement on E. coli O104 outbreak in Europe

The U.S. FDA has been in routine contact with the European Union and the U.S. Centers for Disease Control and Prevention to monitor the current outbreak of E. coli O104 and to track any illnesses in the U.S. that may be related to the outbreak