Testosterone Products Need Post-Market Cardiovascular Trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Labeling updates will also clarify approved uses and warn of possible increased risk of heart attack and stroke; impact on products in development unclear.
You may also be interested in...
Another Testosterone Warning – This Time For Abuse
Action follows agency review of 81 adverse events reported with testosterone/anabolic androgenic steroid misuse, abuse, or dependence over 45 years; discussions continue on cardiovascular study.
Product Liability Suits: Testosterone, Lipitor Grow While Yaz, Pradaxa Settle
2014 saw some big settlements in personal injury suits involving Rx drugs, but it’s unclear whether this is a trend or just situation-specific decision-making, since fierce litigation continues for many other products.
Disease-Awareness Ads Thrive In Regulatory No-Man’s Land
FDA says its hands are tied when it comes to curbing practices such as the testosterone ads its advisory committees have found problematic, but are the agency’s powers really that limited?