FDA committees to discuss testosterone therapies

FDA's Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees will meet on Sept. 17 to discuss the appropriate indicated population and the potential for adverse cardiovascular outcomes with testosterone replacement therapies. In January, FDA said it was investigating the risk of stroke, heart attack and death in men taking approved testosterone products, which are approved for men who lack or have low testosterone levels with an associated medical condition. The agency noted that two separate trials found an increased risk of CV events in men prescribed testosterone therapy. ...