FDA says Testosterone Treatment must include Blood Clot Warning

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Last week, the US Food and Drug Administration told the manufacturers of testosterone treatments that they must properly warn of the risk of blood clots. Blood clots that form in the veins can be life-threatening if they break free and travel to the lungs, which is known as a pulmonary embolism.

Previously, the FDA had warned of an increased risk of blood clots for men who were taking testosterone treatments and also had a health condition in which there was an unusual increase in red blood cell count. The new warning issued by the FDA last week refers to a generalized risk of blood clot without the existing health condition. The FDA began receiving many reports of men suffering blood clots who did not have the red blood cell condition and were taking testosterone treatments.

The agency says this new warning is unrelated to the investigation they launched this past January. In that ongoing evaluation, the FDA is looking into the possible link between testosterone treatment and the risk of stroke, heart attack and death.

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