FDA to review testosterone therapy risk

FDA Will Review Safety of Testosterone Therapy
FDA Will Review Safety of Testosterone Therapy

HealthDay News -- The FDA plans to further examine the risk of cardiovascular disease with testosterone therapy, after findings from two studies suggested an increased risk of cardiovascular events among men prescribed the popular hormone treatment.

"FDA is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products," the agency said in a press release. "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."

In a study published Wednesday in the journal PLOS ONE, an increased risk for heart attack was found in men younger than age 65 years 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, study researcher William Finkle, PhD, CEO of Consolidated Research in Los Angeles told HealthDay.

The other study, published in JAMA this past November, found that veterans taking testosterone therapy had significantly increased risk for stroke, heart attack and death.

The agency is emphasizing that it 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 healthcare professionals," the agency said, but added that clinicians "should consider whether the benefits of FDA-approved testosterone treatment are likely to exceed the potential risks of treatment."

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