FDA to evaluate risk for CV events with testosterone therapy

The FDA announced today that it is reassessing the risk for stroke, MI and death in men who use FDA-approved testosterone products, according to a safety announcement.

The decision to re-evaluate the safety of testosterone therapy follows results from two observational studies indicating a greater risk for CV events among patients receiving this treatment. The approved formulations under reassessment include topical gel, transdermal patch, buccal system and injection, according to the release.

One study, published in JAMA in November, evaluated older men (mean age, 60 years) with low testosterone levels enrolled in the US Veterans Affairs health system. Many = participants also had underlying CVD. Men who received testosterone therapy had a 30% increased risk for stroke, MI and death compared with nonrecipients.

The second study, published in PLoS One on Jan. 29, evaluated younger and older men who were prescribed testosterone therapy. In this cohort, patients aged 65 years or older were had double the risk for MI within 90 days of first prescription, and men aged younger than 65 years with a history of CVD had double to triple the risk for MI within the same time period. Researchers for this study observed no risk increase among younger men without history of CVD.

The FDA has yet to conclude that approved testosterone therapies increase CV event risk, and does not recommend that patients stop taking current treatments without discussing the decision with their physicians. However, the statement urges health care professionals to consider whether the benefits of such therapies outweigh the potential risks in their patients.

“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,” the FDA stated in the release.