FDA investigating risk of stroke, heart attack and death with testosterone products

The US Food and Drug Administration said on Friday that it is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.

The FDA noted that it has 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.

At this time, the agency 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 health care professionals. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment.