FDA Investigating CV Risk and FDA Approved Testosterone Products

The U.S. Food and Drug Administration (FDA) announced that it is investigating the risk of stroke, heart attack and death in men who are using FDA-approved testosterone products. According to the Agency, the evaluation was prompted by the publication of two new studies that indicated an “increased risk of cardiovascular events” in men who were on testosterone therapy. At this time, the FDA has not come to any conclusions regarding if testosterone treatment results in increased risk of cardiovascular events. The Agency will continue to investigate the situation and will provide recommendations once the evaluation is completed. “Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment,” noted the FDA.

To read the full FDA safety announcement, click here.

Keywords: Myocardial Infarction, Risk, Stroke, Testosterone, United States Food and Drug Administration

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