Drug companies continue to push prescription “Low T” treatments, despite the fact that thousands of men have filed litigation claiming they suffered from heart attacks or strokes after using the medications. Brands of Low T — including AndroGel, Testim, Axiron, Depo-Testosterone, Androderm and Fortesta — have used aggressive marketing campaigns to target aging men to the tune of more than 2.3 million prescriptions in 2013 alone. The advertising campaign made many men aware of the condition known as “Low T,” and they visited their doctors for treatment.
The U.S. Food and Drug Administration (FDA), however, does not recognize Low T as a health condition, because the symptoms are also indicative of natural male aging. Because of this, the drugs were never approved for this use by the FDA. There are no regulations in place preventing doctors from prescribing drugs for unapproved use, but drug companies are not allowed to market medications for the treatment of unapproved conditions. This is known as off-label use, and is typically based primarily on empirical evidence.
The FDA became aware that Low T medications were being used extensively to treat symptoms of Low T in individuals who seemed to just be aging. In March 2015, the FDA took action. They announced that warning labels must be included on all approved prescription testosterone products, warning of the possible increased risk of heart attack and stroke. The label must also clarify the approved use of the medication. The prescription medications have only been approved by the FDA to treat Low T caused by a certain medical conditions, such as disorders of the testicles, pituitary gland, orbrain that cause hypogonadism.
If you or a loved one has experienced a cardiac event such as a heart attack or stroke or a blood clot such as a DVT or PE after using a Low T medication, you may be entitled to compensation. Contact the Low T lawyers at the Levensten Law Firm at www.levenstenlawfirm.com, www.androgellawyers.com or 215-545-5600 for a free consultation.