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Group calls for black box warning on testosterone


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The advocacy group Public Citizen on Feb. 25 petitioned the U.S. Food and Drug Administration to require a black box warning on testosterone products. The call was based on recent studies that link the use of those drugs to an increased risk of heart attack and other cardiovascular disorders.

If the studies are valid, then millions of men will have used these drugs while they were egregiously uninformed of the serious increased risks that the manufacturers should have known and should have warned patients and health care providers about. These circumstances are a recipe not only for avoidable patient injury but for product liability lawsuits in which victims seek compensation for their injuries.

The FDA announced that it has not concluded the existence of an increased cardiovascular risk in taking testosterone-containing drugs. The agency merely said that it has been keeping an eye on the science.

“We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy,” the FDA wrote in its Jan. 31 statement. “FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete.”

But in the face of prevailing data, Public Citizen believes now is the time for a more proactive regulatory approach to patient safety; hence the call for a black box warning.

A black box warning, the FDA wrote in a guide to drug safety terms, “appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.”

“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,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “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.”

Public Citizen cited ominous science as one of its reasons for the petition. The organization wrote, “The petition also was prompted by the most recent study, involving the experience of 55,000 men before and after starting testosterone. The risk of heart attacks among men 65 and older during the first three months of using the drug was twice the risk seen in the year before use. Further, the study found, for the first time, a 2.9-fold increase in heart attack risk among men under 65 with a history of heart disease who took testosterone.”

Men who suffered cardiovascular injury after taking testosterone should know that the experienced attorneys at Reich & Binstock have a laudable track record in product liability litigation against pharmaceutical corporations.

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