Regulatory Focus™ > News Articles > Low Testosterone Treatments May Carry High Risk of Cardiovascular Failure, FDA Says

Low Testosterone Treatments May Carry High Risk of Cardiovascular Failure, FDA Says

Posted 04 February 2014 | By Alexander Gaffney, RAC

US regulators warned Friday that treatments intended to raise testosterone levels in men with low levels of the hormone-a condition popularly known as "Low-T"-may also be raising something else in men: their risk of stroke, heart attack and death.

Two separate studies, one in the Journal of the American Medical Association (JAMA) and the other in the journal Public Library of Science: Medicine (PLoS Medicine), showed an elevated risk of cardiovascular events. The JAMA study suggested a 30% increase in risk of stroke, heart attack and death in those taking products intended to treat Low-T, while the PLoS study showed that older men (ages 65 and older) exhibited a two-fold increase of heart attack and younger men with a history of heart disease had a two- to three-fold increased risk of the same.

Safety Review

FDA said that it is embarking on a reassessment of testosterone treatment, but stopped short of asking physicians to immediately alter their prescribing habits. Still, the warning could serve to slow the prescribing of the drugs in the interim. Low-T drugs like Abbott's Androgel are heavily marketed, often with vague-sounding symptoms that critics say could lead to an over-prescribing of the drugs to patients who might not stand to benefit.

As FDA notes in its warning, "None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition."

The drugs are already subject to a number of serious safety warnings, including that accidental exposure to testosterone (such as by family members) may cause health problems. The drugs also contain warnings that patients should tell their doctors if they have prostate cancer, heart problems, kidney or liver problems or urinary problems.

But prior to the completion of FDA's assessment, FDA said it will be up to health care professionals alone to "consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment."

FDA will issue "final conclusions and recommendations" when it completes its review, it said.


FDA Warning

FDA Statement

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