The FDA has requested that two of its internal committees hold a joint meeting in September regarding the potential risks of testosterone therapy medications. This request comes as the scrutiny on these medications intensifies. More and more allegations are being made that using these drugs leads to serious health consequences that include heart attacks, strokes and death. The purpose of the meeting is to determine what steps the FDA should take to regulate these medications. The need for defining when a man actually needs testosterone replacement therapy is also something that will be analyzed. The hope is that efforts like this one will lead to a more uniform set of standards and expectations.
The meeting will be held on September 17. It will include the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. These committees are comprised of experts who can help to identify issues, challenges and risks with low testosterone medications. These committees do not make policy, but they do wield considerable influence on the policies that the FDA ultimately adopts. There is a lot of pressure on the FDA right now to put some regulations in place considering the number of low testosterone lawsuits that are being filed across the country.
New Problems and New Steps Taken
It has been alleged by users of medications such as AndroGel, AndroDerm, Testim and Axiron for some time now that using these medications can lead to heart attacks and strokes. Recent months have revealed other allegations regarding testosterone medication side effects. Earlier this summer, the FDA began to require that the makers of these medications place warnings on their labels regarding the risk of developing venous thrombosis. Venous thrombosis is a condition whereby blood clots form in the veins. Some form in the thigh area, and this is a condition known as DVT, or deep vein thrombosis. These blood clots can be extremely dangerous if they are not detected.
In response to this growing body of data, other countries around the world are taking steps to warn people of the potential risks of testosterone replacement therapy, or TRT. Health Canada issued what is known there as a Safety Update in July after reviewing evidence relating to these medications. That Safety Update specifically stated that using testosterone medications increases the risks not only of heart attacks and strokes, but also of pulmonary embolisms, deep vein thrombosis or irregular heart rates.
The FDA Advisory Committee Meeting and Your Legal Rights
Many people hope that this forthcoming FDA meeting will lead to some tangible results for the regulation of these medications. While that would be a positive step, it would not accomplish anything for those who have already suffered as a result of using these drugs. If you or someone you love has been harmed by TRT, you need to contact the testosterone therapy lawyers at Parilman & Associates as soon as possible to schedule a free initial consultation. You can either email the firm or call 800-800-DRUG.