FDA Requires New Testosterone Warning for Heart Attack and Stroke
Testosterone Injury Lawsuits
The FDA issued a new labeling requirement on March 3, 2015, for manufacturers of prescription testosterone products to inform healthcare professionals and patients about a possible increased risk for heart attacks and strokes in patients taking these drugs. The FDA also included a caution that prescription testosterone products are only approved for men who have low testosterone levels caused by certain medical conditions.
This requirement comes after the FDA conducted its own investigation into the safety of these drugs and met with the Drug Safety and Risk Management Advisory and Bone, Reproductive and Urologic Drugs Advisory Committees in September 2014 to discuss testosterone replacement therapy drugs and cardiovascular risk.
Testosterone Blood Clot Warning
This new warning for heart attack and stroke is the second prescription testosterone warning issued by the FDA. In June 2014, the administration warned doctors and patients of an increased risk for venous blood clots, also known as deep vein thrombosis (DVT), pulmonary embolism (PE), and venous thromboembolism (VTE).
The market for prescription testosterone has been growing aggressively since 2001 when drug makers coined the term “Low T” or low testosterone and urged men who were tired, overweight, or suffered from low libido to speak with their doctors about Low T. Annual revenues for prescription testosterone topped $2.4 billion in 2013 and are expected to reach $3.8 billion by 2018 according to statista.com. Popular makers of prescription testosterone drugs include:
- AndroGel — Abbott Labs (AbbVie)
- Axiron— Eli Lilly
- Testim/ Testopel— Auxilium Pharmaceuticals
- Androderm— Actavis (formerly Watson Pharmaceuticals);
- Android— Valeant Pharmaceuticals NA
- Depo-Testosterone— Pfizer Inc.
- Fortesta— Endo Pharmaceuticals
- Striant—Auxilium Pharmaceuticals
Testosterone Injury Lawsuits
Men who have taken prescription testosterone and suffered heart attacks, serious blood clots—like pulmonary embolism and DVT, and strokes have filed lawsuits against manufacturers of these drugs. If you or someone you know has taken prescription testosterone and suffered a serious injury, contact us. Our product liability attorneys have talked with hundreds of men who have taken Axiron, AndroGel, Androderm and other prescription testosterone products. Our attorneys are experienced in litigating claims against large drug manufacturers and can provide you with a free case evaluation.
