Makers of testosterone drugs must change the products’ labels to clarify that they are approved for only certain disorders, not to help men deal with aging, U.S. regulators said.
Uses listed for the medications, such as AbbVie Inc.’s AndroGel and Eli Lilly and Co.’s Axiron, are being restricted and warnings are being required in the labels about a potential risk of heart attack and stroke from using testosterone, according to a Food and Drug Administration safety communication on Tuesday.
AndroGel ranked second in AbbVie’s drug sales last year, with $934 million, according to data compiled by Bloomberg.
Indianapolis-based Lilly sold about $179 million of Axiron in 2013 and $122.9 million through the first three quarters of 2014.
“Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland or brain that cause a condition called hypogonadism,” the agency said. “However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging.”
In 2013, 2.3 million patients received a prescription for testosterone, almost double the number in 2010, the FDA staff said in documents in September when it called outside advisers together to discuss testosterone safety.
The FDA said in January 2014 that it was investigating the risk of heart attack and stroke linked to the drugs. A study published in November 2013 suggested that testosterone replacement drugs boost the odds of a heart attack, stroke or dying by 29 percent. Other studies offered conflicting results, showing a decreased risk of mortality among testosterone users.
The FDA also is requiring the manufacturers of testosterone products to conduct clinical trials on the increased risk of heart attack and stroke associated with the drugs.