With Controversy Over Testosterone Side Effects, Public Citizen Wants Product Removed

Silver Spring, MDThe controversy about testosterone side effects continues to mount, with critics saying testosterone is over-prescribed and carries risks that are too high, while others say that view is too narrow and based on faulty science. But Public Citizen has already weighed in with its opinions about testosterone risks, by petitioning the FDA to add a black box warning to the product, alerting patients to the risks of heart attacks and strokes. Meanwhile, testosterone lawsuits have been filed, alleging patients suffered heart problems after using the drugs.

In a petition to the FDA dated February 25, 2014, Public Citizen Founder Sidney Wolfe and Director Michael Carome urge the agency to add a black box warning to testosterone drugs.

Public Citizen also asked that manufacturers of the drugs be required to send a “Dear Doctor” letter to physicians, warning them of the serious adverse events linked to testosterone.

The consumer advocacy group noted that an analysis of 27 randomized clinical trials and an observational study suggested a link between use of testosterone and increased cardiovascular risk. The letter called the FDA “reckless” for stating that it had not concluded that testosterone treatment increases the risk of stroke, heart attack or death.

Public Citizen also cited an important disparity in study results when citing a meta-analysis done of 27 trials. “One of the most remarkable findings of the meta-analysis was that the 13 drug industry-funded trials collectively failed to show any increase in cardiovascular events in the testosterone subjects, but the 14 non-industry-funded trials collectively showed a significant 2.06-fold increased risk with testosterone. There was a significant difference between the cardiovascular risk results from the industry-funded studies and the clearly positive results from those studies not industry-funded.”

The FDA said on January 31, 2014, that it was reviewing the safety of testosterone based on two studies that suggested an increased risk of cardiovascular events in patients who took the drugs. At the time, however, the FDA said it had not concluded that testosterone was linked to an increased risk of heart problems.

Among the studies cited by the FDA was a November 2013 study published in JAMA: The Journal of the American Medical Association, which suggested a 30 percent increased risk of heart attack, stroke and death in men who used testosterone. That study’s results were questioned by critics who expressed concerns about the study’s design. Some of those critics, however, have reportedly received payments from companies linked to testosterone drugs and JAMA has said it does not plan to retract the study.