Public Citizen Wants Black Box on Testosterone Products

by Searcy Denney Scarola Barnhart & Shipley
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There appears to be no shortage of advertising for testosterone products for men to relieve low sex drive and fatigue. But these products remain without any warning on the product labels despite a recent study that showed the risk of heart attack is doubled in men taking Low-T supplement products. The work was published in March in the Journal of the American Medical Association (JAMA).

This is important because the drugs are being aggressively marketed and consumers are responding. There were an estimated 56.3 million testosterone supplements prescribed in 2011, reports USA Today. The sales reached blockbuster status of about $2 billion in 2013.

Writing for Public Citizen, Sydney Wolfe, MD, points at the evidence from 14-non-industry- funded trials showing a two-fold increase in cardiovascular events with testosterone treatment while 13 drug industry-funded placebo trials failed to show any problems.

Another study funded by the National Institutes of Health (NIH) looking at the records of 55,000 men also found that using the hormone for three months doubled the risk of a heart attack or stroke and the risk rose in men over 65 with heart disease.

Now the consumer group, Public Citizen, wants the Food and Drug Administration (FDA) to require a black box warning label, the most stringent alert issued by the agency, to alert patients of the risk of heart attack. The group sent a petition to the FDA in February asking for the extra warning on drugs such as Axiron and AndroGel.

The FDA has not responded and has not issued any conclusion about the risk of cardiovascular events with testosterone products despite the fact that none of the testosterone products are approved for men who have a cardiovascular condition.

Last November a study that looked at the records of more than 8,700 men found the hormone raised the rate of not just heart attack but stroke and cardiovascular events in men with heart disease.

But not everyone agrees with the JAMA study results.

The Wall Street Journal (WSJ) reports that in response, an ad hoc group was formed made up of clinicians and educators. The Androgen Study Group is asking for a retraction to the JAMA’s study conclusions which they called an “unwarranted and unscientific attack” on testosterone’s use as a therapy and a way to generate clients for law firms. Lawsuits have already been filed against Abbott Labs (AndroGel) by users who said they had no idea there was a risk of heart attack or stroke if they took the supplement.

Never mind that the head of the coalition is a urologist from Harvard who has also received payments from one testosterone supplement maker.

Meanwhile the JAMA authors stand firmly by their conclusions about the risk of heart attack among users of testosterone.

JAMA says it has no plans to retract the paper, which was published last month.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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