FDA reassessing testosterone drug safety

Axiron FDA reassessing testosterone drug safetyThe U.S. Food and Drug Administration (FDA) said it plans to review the safety of testosterone replacement drugs after two separate studies indicated a higher risk of adverse cardiac events in men who used the products, including one report that linked the drugs to a doubled risk of heart attack.

The agency said it is issuing the alert as it continues to “evaluate the information from these studies and other available data” that point to a significantly higher risk of “stroke, heart attack, and death in men taking FDA-approved testosterone products,” but advised that patients should not stop taking testosterone-enhancing drugs without first discussing their concerns with their doctor.

“Health care professionals should consider whether the benefits of FDA-approved testosterone treatment [are] likely to exceed the potential risks of treatment,” according to an FDA statement.

One the studies that prompted FDA officials to reassess testosterone drugs was a study of older men in the V.A. health system published in the Journal of the American Medical System (JAMA) in November. That study found an a 30 percent increased risk of stroke, heart attack, and death in the group of study subjects that had been prescribed testosterone therapy versus those in the study who did not use the drugs.

The other study reported an increased risk of heart attack in older men, as well as in younger men with pre-existing heart disease, who filled testosterone drug prescriptions. Researchers reported the risk of heart attack among men aged 65 years and older doubled in the first 90 days following the first prescription. The risk of heart attack rose two to three times in men younger than 65 with a pre-existing history of heart disease, within the first 90 days following a first prescription. Younger men without a history of heart disease who filled a testosterone prescription, however, did not have an increased risk of heart attack.

The new FDA advisory comes amid a boom in the sales and use of testosterone-boosting products that come in the form of transdermal patches, injections, oral applications and topical gels. Pharmaceutical companies have sunk millions of dollars into aggressive direct-to-consumer advertising campaigns that have helped sales of testosterone drugs such as AbbVie’s AndroGel, Eli Lilly’s Axiron, and Auxilium’s Testim achieve blockbuster status.

Analysts expect sales of testosterone drugs to triple within the next five years, bringing in annual sales of $5 billion.


U.S. Food and Drug Administration