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Testosterone Heart Attack Risks Being Evaluated by the FDA

Feb 2, 2014

After two studies linked testosterone therapy to increased heart risks, the U.S. Food and Drug Administration (FDA) is deciding to reassess the risks of testosterone products. Earlier today, the agency issued a safety announcement stating that it “is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products.” The FDA advised patients and healthcare professionals to report any side effects associated with testosterone use to the agency’s MedWatch system.

The investigation was prompted by two recent studies that “suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.” the FDA said. This week, a study in PLoS ONE found that testosterone therapy doubled the risk of a heart attack in men over 65 and tripled the risk of heart attack in younger men with a history of heart disease. Testosterone products were also linked to an increased risk of stroke, heart attack and death in another study, published by PLoS ONE in November; those men were treating “low T” and had a history of heart troubles.

The link between heart risks and testosterone therapy is especially concerning because in some cases, it appears that men are being prescribed testosterone without a medical need. Testosterone is an essential hormone that promotes male growth and masculine characteristics. The FDA notes that it has only approved testosterone therapy for men who have low levels of testosterone associated with a medical condition, such as hypogonadism or chemotherapy. “None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.” the agency stated.

It appears, however, that many men have been taking testosterone products for non-medical purposes. This may be at least partly due to marketing by drug companies who push testosterone as a way to treat “low T” symptoms such as a low sex drive, mood changes and energy loss. According to a report in JAMA, there were 5.3 million prescriptions for testosterone in 2011, five times as high as in 2000. Only half of these men, however, were actually diagnosed with having abnormally low levels of testosterone; one-quarter had never even tested their levels and the remaining men were being treated for conditions such as fatigue or low sex drive.

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