FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

For Immediate Release:December 11, 2019 The U.S. Food and Drug Administration today posted a warning letter to Alkermes, Inc. of Massachusetts, for misbranding the drug Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about the most serious risks associated with the drug from promotional materials. Vivitrol is approved for the prevention of relapse to opioid … Continue reading FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

FDA Says Certain Antibiotics Could Rupture Main Artery

They're certain antibiotics, known as fluoroquinolones. Popular brand names include Avelox, Cipro, and Levaquin. Now, the U.S. Food and Drug Administration says these antibiotics "can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body," the aorta. The FDA says these ruptures "can lead to dangerous bleeding or … Continue reading FDA Says Certain Antibiotics Could Rupture Main Artery