Expert Panel Urges FDA to Create Limits on Testosterone Drugs

An expert panel nearly unanimously voted to impose strict new limitations on the testosterone drug industry. The panel is recommending that the Food and Drug Administration (FDA) tighten up labels for the medications to prevent over-prescribing of the drugs.

Since the early 2000s, the use of testosterone therapy, or Low T therapy, has quadrupled. More and more men have begun taking testosterone drugs after companies began claiming that the drugs could solve problems such as low libido and low energy. If the FDA decides to heed the panels suggestions, which they often do, it could reduce the number of prescriptions being written out as well as how these drugs are marketed.

The panel received information on how and why Low T drugs were being prescribed. Only one fifth of men who were prescribed testosterone had been given a baseline test to assess their testosterone level. The majority of doctors prescribing these medications were primary care physicians rather than specialists like urologists and endocrinologists.

Only one of the panelists voted against the creation of limits as well as to require clinical trials for safety for some types of Low T therapy. However, the FDA is already taking the panels suggestions seriously as they recently rejected a new oral testosterone-replacement drug after finding that the benefit-risk profile was not sufficient enough.

In 2014, several research papers claimed that testosterone therapy was significantly increasing the chances of heart attack among men over the age of 65.

If you or someone you love was prescribed a low T treatment and experienced a heart attack, you may wish to seek the services of a licensed West Palm Beach personal injury attorney to file a claim for your injuries, pain and suffering. The class action lawyers at Gordon & Partners can help your determine what your legal rights are.

Contact us at 1 (855) 722-2552 or fill out our online contact form to schedule a free legal consultation.