Share:

Posted by Marilyn McGoldrick on Jun 26, 2014 10:33:51 AM

The FDA announced that it is requiring manufacturers of Low Testosterone (Low T) replacement products to add a warning to the product label of the risk of developing venous blood clots. Based on post-market reports of venous blood clots in the absence of polycythemia, the FDA will now require a general warning to men who use Low-T products that they may develop venous thromboembolism (VTE), including deep vein thrombosis (DVT), when venous blood clots form deep within the body, or pulmonary embolisms (PE), when those blood clots break off and travel towards the arteries in the lungs.

The warning about venous blood clots is unrelated to the FDA’s previously announced investigation of the risk of stroke, heart attack, and death from using prescription testosterone products. The FDA’s investigation into these cardiac events  and their relationship to Low T products is still ongoing.

The FDA encourages doctors and patients who experience adverse events while using testosterone replacement therapy to report those side effects to the FDA Medwatch Program, either by filing the form online or by printing out the form & faxing it to 1-800-FDA-0178.

If you have experienced VTE, either deep vein thrombosis, or pulmonary embolisms, while using Low testosterone replacement by prescription, you may have a legal claim. Thornton Law Firm is currently investigating claims on behalf of men who have suffered venous blood clots, a heart attack, or stroke while taking prescription testosterone replacement (Low-T) therapy. Please tell us your story here, or contact our Massachusetts Low T lawyers at 1-888-491-9726 for a free, confidential consultation. All legal claims have rigid time limits, so do not delay looking into your legal rights.