Group asks for heart risk warning on testosterone products

Recommended by Dr. Michael White, Updated on November 14th, 2020
Reading Time: 2 minutes

A public advocacy group is asking the Food and Drug Administration to add black box warnings about heart attack and other cardiovascular risks linked to taking testosterone products.

Public Citizen made the appeal on Tuesday, citing studies that have linked heart problems to taking the hormone.

The black box warning is the strongest warning that the FDA can require companies to put on their products. It alerts users that the medication has a high risk of causing adverse health effects, including ones that can lead to death.

In the face of this accumulating evidence, this statement is reckless and is a betrayal of the FDAs role as an agency in the U.S. Public Health Service, Dr. Sidney Wolfe, founder and senior adviser of Public Citizens Health Research Group, said in a press release. It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks.

The group also asked the FDA to delay its decision on a long-acting injectable testosterone product called Aveed because it doesnt have the black box warning. Aveed was supposed to hit the market on Feb. 28.

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Testosterone therapy may be gaining in popularity, but a new UCLA study found that within 90 days of starting treatment, the risk of heart attack...

Testosterone increases red blood cell production and red blood production can lead to cells that coagulate, study co-author and UCLA epidemiologist Dr. William Finkle, told CBS Los Angeles.

Another study published in November 2013 in the Journal of the American Medical Association showed that older men -- most of whom had pre-existing heart disease -- had a 29 percent increased of heart attack, stroke or death when taking testosterone.

"We certainly now have to take a pause and say, 'Listen, we need long-term data before we tell a 40-year-old with low T to go on this medicine,'" CBS News contributor Dr. David Agus told CBS This Morning.

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Group asks for heart risk warning on testosterone products

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