FDA Panel Recommends Limiting Use of Testosterone

Washington DCAn FDA advisory panel has recommended limiting the use of testosterone drugs and has recommended the makers of the drugs conduct a study into possible testosterone side effects. Of concern is a potential link between the use of testosterone products and an increased risk of heart attack or stroke. Testosterone lawsuits have been filed alleging patients were not adequately warned about some of the risks associated with the medications.

According to The Wall Street Journal (9/17/14), the FDA convened an advisory panel to make recommendations about testosterone therapy amid growing concerns about a link to drugs containing testosterone and possible cardiovascular side effects. Testosterone therapy is approved for use in men who have low levels of testosterone along with a medical issue that would explain the condition, such as undergoing chemotherapy. But testosterone is frequently prescribed off-label for men attempting to treat a lifestyle issue - such as low sex drive - rather than a medical issue.

The advisory panel was asked to consider whether the FDA should change the appropriate patient population for testosterone therapy and whether further studies should be conducted to determine a possible link between testosterone and cardiovascular risks. One of the issues facing the FDA is whether the symptoms patients taking testosterone face are the natural result of aging or the consequence of a disease. Men typically naturally face a decline in testosterone levels as they get older.

The FDA briefing documents, provided prior to the meeting, note that in 2010 there were 1.3 million patients who received a testosterone prescription. By 2013, that number was almost double, at 2.3 million. The majority of patients who are prescribed testosterone are men between the ages of 40 and 64.

In the briefing documents, the FDA noted a lack of “convincing evidence” that testosterone replacement therapy is associated with adverse cardiovascular outcomes. Studies that do suggest an increased risk of cardiovascular problems tend to have a small sample size, short duration and other factors that make them less reliable.

CBS News reports that the FDA panel voted 20-1 that the label for testosterone products should be rewritten to include information that the products have not been proven to treat issues that are associated with aging. Although this change would limit the FDA’s approved uses of the drug to men who have low testosterone due to disease, it might not have an effect on physicians prescribing the drugs for lifestyle reasons. Physicians are free to prescribe medications for off-label use.

The panelists also voted to require testosterone drugmakers to conduct further studies into the cardiovascular implications of using testosterone products.

The FDA does not have to follow the recommendations of its advisory panel and has not yet made an announcement as to whether or not it will in this case.