FDA to Require Blood Clot Warnings on Testosterone Products

On June 20, 2014 the United States Food and Drug Administration announced that it would require the manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE).

See the FDA announcement here.

This new warning, which is a class warning (affecting all testosterone products) is not related to an ongoing FDA investigation into the risk of stroke, heart attacks and death that may be related to the use of these products. That investigation has been ongoing since January 31, 2014 and FDA has not yet issued any findings or conclusions.

The Locks Law Firm is actively investigating cases of stroke, heart attack, blood clots in the veins, pulmonary embolism and death in users of testosterone products, especially those prescribed for what is known as “low-T syndrome.” If you, a friend or a loved one has used a testosterone gel, cream, patch or other testosterone formulation and suffered any of the conditions mentioned above, please contact the Locks Law Firm.