Testosterone Drugs Shold Warn of Heart Problems, Consumer Group Says

A consumer advocacy group is calling for the Food and Drug Administration (FDA) to require a black box warning label on drugs used to treat low testosterone.

The consumer advocacy group Public Citizen called on the FDA this Tuesday, demanding that U.S. regulators immediately add a black box warning -- the most severe of FDA warnings -- to drugs and patches designed to treat low testosterone. According to the Public Citizen petition, testosterone drugs have been found to increase risk of heart attacks and other cardiovascular dangers in patients.

The advocacy group backed their claims citing a recently published meta-analysis that looked at 27 studies of testosterone drugs over the last two decades. Although 13 of the studies showed no evidence of increased risk of cardiovascular complications while receiving testosterone treatments, Public Citizen's experts are quick to point out that those studies were funded by the drug industry. Interestingly, all of the remaining 14 third-party studies showed a "significant" increase in cardiovascular risk among patients who regularly received testosterone therapy.

Along with their demand for the black box implementation, the advocacy group is also asking that the FDA send "Dear Doctor" letters to physicians citing the mentioned studies and warning doctors who prescribe testosterone treatments to their patients of the "serious adverse effects." Lastly, Public Citizen is demanding that the FDA-approved Medication Guide for testosterone products be updated with an adequate warning.

However, FDA officials say they cannot make such game-changing decisions based off a petition and a handful of unofficial studies alone.

Aware of concerns about testosterone drugs and cardiovascular complications, and following its own brief alert and investigation, the FDA stated on Jan 31 that it "has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death."

In a recent press release, Dr. Signey Wolfe, the founder and senior advisor or Public Citizen's Health Research Group called the FDA's statement following its month-long investigation into testosterone treatments "reckless" and a "betrayal ... as an agency in the U.S. Public Health Service."

"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 ... will continue," Wolfe said in the release.

It remains unclear whether the FDA will heed this petition, but with a lack in adequate clinical evidence, it is unlikely that Public Citizen's demands will be met. Still, the petition alone may garner enough interest in the scientific community to earn more studies into weather testosterone treatments really do increase risk of heart complications.

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