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July 2, 2014
New Warning for “Low T” Therapy Involves VTE Risks

Washington, D.C.—The FDA is requiring a new general warning on the drug labels of testosterone products but says it is unrelated to the agency’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients on “Low T” therapy.

The new caution targets venous thromboembolism (VTE), including deep vein thrombosis (DVT), and pulmonary embolism (PE), which develops during testosterone replacement therapy. While the risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, the FDA has received postmarket reports of blood clots in the absence of an abnormal increase in the number of red blood cells, which sometimes occurs with testosterone treatment.

As a result, drug labels now will be required 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 FDA points out that the latest announcement is unrelated to the drug safety communication last January that publicized FDA’s review of the possible link between testosterone therapy and increased risks of stroke, heart attack, and death.

“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,” the FDA announced then. “We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete.”

In the latest announcement, the FDA again emphasized that testosterone products only are FDA-approved for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. That might include failure of the testicles to produce testosterone for reasons such as genetic problems or chemotherapy, according to the FDA.

Recent studies have indicated that many men on testosterone do not meet clinical guidelines for the therapy’s use.


U.S. Pharmacist Social Connect