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FDA decides to investigate safety of testosterone therapy


The Food and Drug Administration announced it is investigating the risk of stroke, myocardial infarction and death in men taking FDA-approved testosterone products.

The FDA stated 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.

“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 agency wrote in a drug safety communication.

At this time, the FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, MI or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their healthcare professionals.

Healthcare professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment, the FDA stated. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.

FDA drug safety communication:


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