Testosterone drugs should warn of cardiac risk, consumer group says

 

Posted on February 25, 2014 by Stone Hearth News

  

(Reuters) – Drugs used to treat low testosterone should carry strong warnings about the risk of heart attacks and other cardiovascular problems, the consumer advocacy group Public Citizen said on Tuesday.
The group has petitioned the U.S. Food and Drug Administration to add a black box warning, the most serious possible, to the product labels of the drugs.
Testosterone therapy is approved by the FDA for men who lack or have low testosterone in conjunction with an associated medical condition, such as a genetic failure of the testicles to produce testosterone.
Symptoms of low testosterone can include loss of libido, depression, decreased muscle mass and fatigue.

  

According to Public Citizen, almost 25 percent of men prescribed testosterone didn’t previously have a blood test to determine if their level was low.
The group said its petition was based on growing evidence of the risks of heart attacks and other cardiac dangers from studies dating back to 2010 and a recently published analysis of 27 studies going back as far as 20 years.
Of the 27 studies, 14 that were not funded by the pharmaceutical industry showed a “highly significant” increased risk, Public Citizen said. Thirteen were funded by drug companies and those studies showed no increased cardiovascular risk.
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