FDA Now Investigating CVD Risks With Testosterone Therapy


January 31, 2014

BETHESDA, MD – The US Food and Drug Administration (FDA) is now officially investigating the potential that FDA-approved testosterone products increase the risk of serious adverse cardiovascular outcomes[1].

The agency cites two studies, one of which was published just two days ago, both reported by heartwire , that suggests men taking the testosterone supplements have an increased risk of death, MI, or ischemic stroke.

"We are providing this alert while we continue to evaluate the information from these studies and other available data and will communicate our final conclusions and recommendations when the evaluation is complete," according to the FDA.

In the newest study, men treated with testosterone were significantly more likely to have an MI in the first 90 days after starting the medication. In the three months after the start of testosterone therapy, the risk of MI overall was increased by 36% and was even higher in older men. For those aged 65 years and older, the risk of MI was more than twofold higher in the 90 days after filling the prescription.

The second study, which was also an observational analysis, of Veterans Affairs (VA) patients, found that testosterone therapy in men was linked with an increased risk of death, MI, or ischemic stroke.

The agency stresses that testosterone products are approved for use in men with low testosterone levels and an associated medical condition, such as a failure of the testicles to produce testosterone because of a genetic condition or chemotherapy. Other medical conditions include problems with the hypothalamus or pituitary gland that result in low testosterone levels. The FDA says that these testosterone therapies are not approved for men with low levels without the associated medical condition.

The FDA says that patients should not stop taking testosterone therapy unless they first consult with their physician but adds all physicians need to consider the risk/benefit profile when considering a prescription for their patient. "The prescribing information in the drug labels of FDA-approved testosterone products should be followed," they write.


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