FDA Rejects Testosterone Black Box Warning, Schedules Advisory Committee Meeting to Discuss Heart Risks

Published on July 21, 2014 by Sandy Liebhard

U.S. health regulators have rejected a petition seeking a so-called black box warning to alert patients of potential cardiovascular risks associated with AndroGel and other low testosterone therapy medications. However, the Food & Drug Administration (FDA) will convene a meeting of outside advisors in September to take a closer look at the issue.

The prominent consumer advocacy group, Public Citizen, petitioned the FDA in February for the black box warning, citing a number of studies that indicated drugs like AndroGel may be associated with an increased risk of heart attacks, strokes and other cardiovascular problems. The petition also asked the agency to order the manufacturers of testosterone treatments to issue a letter to doctors warning them of these risks.

In rejecting the Public Citizen petition, the FDA said the studies cited by the group suffered from a number of limitations, including small sample sizes.

“FDA has considered the studies submitted in support of your requests, which were all known to the agency prior to the submission of your petition, and concludes that at this time, there is insufficient evidence of a causal link between testosterone therapy and adverse cardiovascular outcomes to support the regulatory actions requested in your petition,” the agency’s July 17^th denial letter said.

Advisory Committees to Investigate Testosterone Heart Risks

The FDA has been investigating the heart side effects associated with testosterone replacement therapy since January. The same day the agency issued its denial letter to Public Citizen, the FDA announced that it’s Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee would meet jointly on September 17^th to discuss cardiovascular risks associated with testosterone treatments. Among other things the Committees will also address what factors should be considered when deciding whether men need to use low testosterone therapy.

Meanwhile, the manufacturers of AndroGel and similar medications continue to be named in testosterone lawsuit claims that allege the drugs caused patients to suffer heart attacks, strokes, blood clots and other cardiovascular problems. On July 10^th, an Initial Status Conference was held in the U.S. District Court, Northern District of Illinois, where at least 156 such cases have been consolidated for coordinated pretrial proceedings.