Testosterone Heart Risks Require Black Box Warning: Public Citizen

The prominent consumer watchdog group Public Citizen is calling for federal drug regulators to require a new “black box” warning about the potential heart risks of testosterone replacement therapy, such as AndroGel, Testim, Axiron and other products.

In a petition (PDF) filed with the FDA on February 25, the group calls for the strongest warning label possible for the medications, citing a number of studies that have suggested side effects of testosterone treatments may increase the risk of heart attacks, strokes, blood clots and death.

Public Citizen is also urging the FDA to issue a “Dear Doctor” letter to medical providers to warn them of the potential testosterone heart risks. In addition, the group indicates that the agency should delay approval of a new long-acting testosterone injection proposed by Endo, known as Aveed. The FDA is set to decide whether to approve the product in the near future.

On January 31, the FDA announced that it has launched an investigation into the heart safety of testosterone therapy. That safety alert came after two studies were published in recent months that found an increased risk of cardiovascular events among men prescribed testosterone gels, patches, injections or other treatments.

While concerns about the potential link between heart attacks and testosterone treatments have existed for years, concerns were increased in November 2013, when a study published in the Journal of the American Medical Association (JAMA) suggested that testosterone products were linked to increased risks of heart attacks, strokes and death among older men with certain pre-existing heart conditions.

The JAMA study was followed by a report published by the medical journal PLoSOne in January 2014, which found that low testosterone treatments may double the risk of heart attack for young men with heart disease as well as for men age 65 and older who had no prior heart problems. The researchers estimated that for every 1,000 men over the age of 65 who uses AndroGel or another TRT product, 11.52 may suffer a heart attack. That compares to only 5.27 men per 1,000 who do not use testosterone.

“In the face of this accumulating evidence, this statement is reckless and is a betrayal of the FDA’s role as an agency in the U.S. Public Health Service,” Dr. Sidney Wolfe, from Public Citizen’s Health Research Group, said in a press release. “It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks.”

Millions of Testosterone Prescriptions

Testosterone therapy has increased in popularity in recent years, as direct-to-consumer marketing has encouraged men to seek prescription treatment for low testosterone levels, or “low T”, if they are experiencing fatigue, decreased sexual virility or other symptoms that are often common with aging.

In recent years, the use of AndroGel, Androderm, Testim, Axiron and other similar testosterone treatments has increased more than a factor of five, with more than $1.9 billion in sales in 2012. More than five million testosterone product prescriptions were filled last year in the U.S. alone.

Critics say that when you add those numbers into the booming testosterone industry and the vast number of prescriptions, often to men who do not need testosterone, the number of men who may suffer heart problems due to testosterone is staggering.

“Unless the FDA immediately begins to provide strong, adequate black-boxed warnings about the risks of heart attacks and other cardiovascular diseases, the continuing toll of heart attacks, many in people who are not even candidates for testosterone, will continue,” Wolfe stated in the press release. “At the present rate of prescribing, almost 13,000 prescriptions a day are filled for testosterone products in this country. Each day of delay of the black box warning ensures much more exposure, too often for men who cannot benefit from the drug but will only be exposed to its risks.”