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Advocacy Groups: Testosterone Products Need Black-Box Warning About Heart Attack Risk

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white pills spilling out of a bottle with a blurred warning

Despite a growing number of studies pointing to increased heart attack risk with testosterone replacement therapy drugs, the U.S. Food and Drug Administration (FDA) has yet to require warning labels on testosterone products.

Drug companies, including AbbVie Inc., which manufactures AndroGel, are marketing their testosterone replacement drugs aggressively to treat “Low T” – a low testosterone condition with symptoms like fatigue and low sex drive.

However, an extensive study published in January in PLoS One revealed that testosterone products can double the risk of heart attacks in men. Doctors and advocacy groups are concerned about those results because so many U.S. men take these drugs.

According to USA Today, an estimated 5.3 million men received prescriptions in 2011. That number is climbing rapidly. The products generate high profits for drug companies, too. They raked in about $2 billion from selling the drugs in 2013, FiercePharma estimates.

Push to Require Black Box Warnings

Cardiologist Francisco Lopez-Jimenez, of Mayo Clinic in Minnesota, told USA Today the heart risk associated with testosterone therapy is worrisome.

“That’s the equivalent to smoking one or two packs of cigarettes a day, or having sky-high cholesterol,” Lopez-Jimenez said.

Washington-based nonprofit Public Citizen is leading the push to get black-box warning labels added to testosterone drug packages. It petitioned the FDA in February to require warnings for heart attacks, strokes and other cardiovascular risks on labels of popular testosterone products, including AndroGel and Axiron.

FDA regulators can require drugmakers to place black-box warnings — the agency’s strongest alert — on labels of drugs that carry a significant risk or life-threatening side effects.

These side effects already are affecting testosterone users who say they were not warned of the risk. A handful of men who suffered heart attacks and strokes after taking AndroGel filed lawsuits against Abbott Laboratories and its spinoff, AbbVie, in February.

Public Citizen successfully helped ban a number of dangerous drugs over the years, and it says there is enough evidence gathered from at least 14 independent studies to merit stronger warnings.

The FDA has not issued Public Citizen a formal response to the petition.

FDA Is ‘Asleep at the Wheel’

In an interview with Drugwatch, Dr. Sidney Wolfe, the senior adviser and founder of Public Citizen’s Health Research Group, said the FDA is “asleep at the wheel” when it comes to regulating testosterone advertising campaigns that inflate the benefits of the drugs, while downplaying the risks.

“Despite this accumulating evidence, the FDA stated that it ‘has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack or death,'” Wolfe wrote in the February issue of BMJ.

Wolfe also said the FDA’s statement was “reckless from a public health perspective.”

The latest data shows that 1 in 100 men who take testosterone may suffer a heart attack. According to Wolfe, the number of prescriptions is now about half a million a month, and the FDA is now exposing an increasing number of men to the risk without a proper warning.

Controversy over Studies

Not all doctors are concerned about cardiovascular risks.

A recently formed organization, called the Androgen Study Group, demanded the Journal of the American Medical Association (JAMA) retract a 2013 study co-authored by senior investigator Dr. Michael Ho, of VA Eastern Colorado Health Care System.

The study, which showed that testosterone increased heart attack risk in test subjects, led to an FDA investigation into the drug. But Abraham Morgentaler, associate clinical professor of urology at Harvard Medical School and head of the Androgen Study Group, told the Wall Street Journal “there is nothing believable” in the study because of two corrections made post-publication.

WSJ points out that AbbVie and other testosterone drug manufacturers paid Morgentaler and others in the Androgen Study Group to research and promote the drugs.

JAMA refuses to retract the article, and Dr. Ho defends its content, despite the correction.

“In the original publication, there was misclassification of the reasons why patients were excluded,” he told the WSJ. “This was corrected in [our] response letter that was provided to and published in JAMA. But this did not change the results of the paper.”

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