FDA Warns Testosterone Not Approved for Low Testosterone Due to Aging and May Cause Heart Attack and Stroke; Requires Label Change
The U.S. Food and Drug Administration (FDA) issued a Safety Announcement on March 3 warning the public that testosterone products are not approved for use in treating low testosterone as a result of aging. The warning addresses increased prescription of testosterone therapy to treat males suffering from low testosterone as a result of aging and requires manufacturers to change their labels to reflect this information. Testosterone therapy has been approved only for treatment of low testosterone as a result of disorders of the testicles, pituitary gland, or brain, causing a condition known as hypogonadism. No other Indications have been approved by the FDA because there is sparse data supporting the efficacy of testosterone for patients that don’t suffer from the aforementioned diseases.
The FDA also required all testosterone manufactures to update their product labeling to warn that there “is a possible increased cardiovascular risk associated with testosterone use.” These risks included heart attack, stroke, or death associated with testosterone treatment. Manufacturers are also being ordered to perform additional testing.