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FDA Wants Blood Clot Warnings on Testosterone Drugs

Update Date: Jun 21, 2014 10:51 AM EDT

The United States Food and Drug Administration (FDA) is now requiring drug manufacturers of testosterone products to include a new label warning men about the general risk of blood clots.

Currently, the testosterone therapy products available on the market inform consumers about the risk of blood clots related to a condition known as polycythemia. Polycythemia is a rare condition that occurs when the levels of red blood cells increase abnormally often due to testosterone treatment. However, according to new research, the risk of blood clot in the vein, which includes deep vein thrombosis (DVT) and pulmonary embolism, was elevated in people without the particular condition.

The FDA stated that based on new research, testosterone treatments might increase people's risk of blood clots regardless of whether or not the patient has developed polycythemia. Testosterone treatments are prescribed to men who lack or have extremely low levels of the hormone usually due to medical conditions. Men with testosterone problems often suffer from symptoms such as a loss of libido, depression, fatigue and reduced muscle mass.

The agency is currently investigating the potential side effects of taking testosterone treatments.

"FDA is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products," the agency stated reported by WebMD. "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."

However, the recent findings regarding blood clots were not related to this ongoing investigation. The agency added that doctors and patients should always discuss the best available treatment plans and address the potential risks involved.

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