The FDA is re-evaluating previously approved testosterone products after two studies suggested the testosterone treatments may increase the risk of stroke, MI and death.
The agency issued an alert to cardiologists, urologists and family practice physicians to inform them that it was investigating the potential safety risk of testosterone products. It cited two separate studies that reported safety signals.
Most recently, a cohort study of 55,593 men who initiated testosterone therapy found that older men and younger men with heart disease may be at increased risk.
The FDA instructed physicians to weigh the benefits and risk of testosterone treatments while it evaluates the studies and other data. Patients should not discontinue treatment without first talking with their physicians.
Patients and physicians are encouraged to report adverse events or side effects from use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.