FDA Orders Testosterone Supplement Makers To Include Blood Clot Warnings
June 22, 2014

FDA Orders Testosterone Supplement Makers To Include Blood Clot Warnings

redOrbit Staff & Wire Reports – Your Universe Online

The US Food and Drug Administration (FDA) is now requiring manufacturers of testosterone supplements to include a general warning label about the risk of blood clots in the veins, various media outlets reported on Friday.

While testosterone products already carry warning labels pertaining to a risk of clots associated with polycythemia, which involved an abnormal increase in red blood cells after use of such supplements, Reuters writer Esha Dey explained that the FDA has received reports of clots independent of that condition.

Based on their findings, the FDA has decided that testosterone supplements should also carry labels warning about the general risk of blood clots in the veins, unrelated to polycythemia, noted E.J. Mundell of HealthDay News. Blood clots occurring in the veins include deep vein thrombosis (DVT), which can form in passengers on long airplane flights, and pulmonary embolism, a potentially life-threatening condition in which a clot reaches the lungs.

Some types of testosterone treatments, which can be administered in gel, patch or injection form, are approved by the FDA for use in men suffering from inadequate hormone production due to genetic defects or chemotherapy. They are also often advertised as a way to help aging males raise their energy levels and sex drives, Mundell noted.

“Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products,” the agency said in a statement Thursday.

“Because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products,” it added. “We are currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in the Drug Safety Communication posted on January 31, 2014.”

According to reports appearing on CNBC.com, testosterone products are also under investigation by federal officials probing incidents of stroke, heart attack and death in men using the drugs. The FDA told reporters that the new warning was not linked to that probe, which the agency launched in February.

“FDA is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products,” it said in a statement at that time, according to Mundell. “We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.”