FDA Removes Heart Attack, Stroke Warnings From Testosterone Drug Labels

FDA Removes Heart Attack, Stroke Warnings From Testosterone Medications

Federal drug regulators issued a class-wide labeling update for all testosterone replacement therapy products, removing warnings about the risks of heart attack and strokes, and replacing them with warnings about high blood pressure, following the completion of several key studies that examined risks associated with the hormone treatments.

When testosterone drugs were initially introduced, they were focused primarily on men who experienced drops in testosterone levels linked to a condition known as hypogonadism. However, once the medications were approved, drug makers began aggressively marketing the niche treatments for normal symptoms associated with aging, resulting in widespread use for a non-medical condition advertised as “low T.”

Prescriptions for the drugs increased more than 300% between 2001 and 2013. However, concerns emerged about the widespread overprescription of drugs like AndroGel, Axiron, Testim, Depo-Testosterone and other gels, creams, patches and injections, after studies found that side effects of testosterone replacement therapy may increase the rate of heart attacks and strokes.

However, in a press release issued on February 28, the U.S. Food and Drug Administration (FDA) has announced it is removing the testosterone heart attack and stroke warnings that were added to the drugs about a decade ago, indicating that more recent studies have found little evidence of a connection between heart problems and testosterone treatments. Instead, the agency called for new label warnings regarding the risk of high blood pressure, which can lead to heart attacks and heart failure.

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Hair-Dye-Cancer-Lawsuits

The decisions came from the findings of the Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial. Federal regulators indicate they also reviewed the findings of postmarketing ambulatory blood pressure (ABPM) studies as well.

The new label warning changes include the removal of a 2014 black box warning of stroke, heart attack and death risks, but will continue to carry “Limitations of Use” language that urges doctors to only prescribe it for age-related hypogonadism. The agency will also add product-specific information on increased blood pressure, based on data from ABPM studies, as well as a general blood pressure warning.

The findings from the TRAVERSE study were first published in June 2023 in The New England Journal of Medicine. Researchers from the Cleveland Clinic in Ohio were unable to find any difference in heart problems suffered by men given testosterone and men who did not take the hormone treatment.

Following prior studies that highlighted potential heart attack and stroke risks, drug makers faced thousands of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other claims, each raising similar allegations that the drugs were recklessly marketed and over-prescribed for years. Following several years of litigation, Testosterone settlements were reached to resolve nearly all pending claims brought in the U.S.


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