The Food and Drug Administration (FDA) has already flagged Low T Medications as potentially unsafe due to heart attack and stroke risks. Now the FDA cancelled a meeting with the advisory committee that would have discussed possible approval of Androxal, a new kind of testosterone drug developed by Repros Therapeutics. The decision suggests that the agency is treading very carefully when it comes to testosterone replacement therapy.
Repros executives said that the FDA told the company it has concerns that the company’s method for measuring testosterone levels has not been properly validated, according to MedPage Today. While the company denies this, it did note that the FDA has questions about who should be treated with the company’s drug, and the drug’s benefits.
The FDA’s concerns about testosterone drugs has grown as studies revealed possible health risks with such drugs. In the spring of 2015, the agency issued a warning that Low T drugs could produce blood clots that could lead to cardiovascular problems, including heart attack and stroke. The FDA’s concern became publicly apparent in new drug labeling that the agency now requires on testosterone drug packaging. The new labeling clearly warns both physicians and patients of the potential health risks. The FDA then took the step of calling on makers of these drugs to conduct additional clinical trials to fully assess the safety risks of these drugs.
The health concerns surrounding Low T drugs continues to mount. If you or a loved one has experienced a stroke or heart attack 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.