The FDA is currently evaluating the risk of stroke, heart attack, and death in male patients taking FDA-approved testosterone products.

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A recent publication of two studies suggests an increased risk of cardiovascular events among male patients prescribed testosterone therapy. It has not been firmly concluded that approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients are advised to not discontinue their testosterone therapy without discussing with their healthcare provider. Moreover, healthcare professionals should weigh the benefits of FDA-approved testosterone therapy to the potential risks.

The FDA is continuing to assess information from available data and will release their final conclusions and recommendations when their evaluation is complete.

Testosterone therapy is only approved for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Some FDA-approved testosterone formulations are available as a topical gel, transdermal patch, buccal system, and injection.

For more information call (800) 332-1088 or visit the FDA Safety Alert page.