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FDA Will Review Safety of Testosterone Therapy
Agency pointed to recent studies citing possible heightened heart risk tied to the treatments

MONDAY, Feb. 3, 2014 (HealthDay News) -- Spurred by a recent report that popular testosterone treatments might raise men's heart risk, the U.S. Food and Drug Administration says it now plans a review of the therapies' safety. "FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products," the agency said in a statement released late Friday.

"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 agency added.

In a study published Wednesday in the journal PLOS ONE, an increased risk of heart attack was found in men younger than 65 with a history of heart disease, and in older men even if they didn't have a history of the disease. In both groups, heart attack risk doubled in the 90 days after the men began testosterone therapy, lead author William Finkle, Ph.D., CEO of Consolidated Research in Los Angeles told HealthDay. This research was prompted by a 2010 report in the New England Journal of Medicine, Finkle said. In that study, a clinical trial of testosterone gel in men over 65 was halted early after an increase in cardiovascular adverse events occurred in the group using the testosterone treatment.

In its Friday statement, the FDA said that, as of now, the agency "has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals." But the FDA also told doctors that they "should consider whether the benefits of FDA-approved testosterone treatment are likely to exceed the potential risks of treatment."

Full Article
NEJM - Full Text
PLOS ONE - Full Text



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