Consumer Group Calls for Black Box Warnings on Testosterone Treatment Labels

TRT Black Box Warnings

Written by Faith Anderson on March 3, 2014
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Consumer Group Calls for Black Box Warnings on Testosterone Treatment Labels

The FDA is being asked by consumer advocates to require the strongest possible warnings on TRT labels, regarding health risks like heart attack and stroke.

The consumer watchdog group Public Citizen is calling for drug regulators to impose “black box” warnings on the labels of testosterone products like Testim, AndroGel and Axiron, warning users about the potential connection between testosterone replacement therapy (TRT) and life-threatening heart problems. In a petition filed with the U.S. Food and Drug Administration (FDA) on February 25, the consumer group cites numerous studies that have linked side effects of testosterone treatments to health risks like heart attack, stroke and death, asking the agency to require the strongest warning label possible for the controversial medications. If you believe you have been adversely affected by side effects of testosterone therapy, consult a knowledgeable testosterone treatment attorney to discuss your legal options.

Possible Side Effects of Testosterone Treatment

Testosterone replacement therapy has become a popular treatment for men with low testosterone levels, but the products are only approved for men with “low T” associated with medical conditions like hypogonadism. Even so, direct-to-consumer marketing of testosterone products has resulted in many men seeking prescription treatment for low testosterone levels associated with symptoms like fatigue and decreased sex drive, which come along with the natural aging process. As a result, men who don’t necessary need a boost in testosterone are being prescribed medications like AndroGel, which have been tied to potentially life-threatening drug side effects like heart attack and stroke.

FDA Investigation into TRT Health Risks

In January, the FDA announced that it was launching an investigation into the health risks of testosterone replacement therapy, after two studies found an increased risk of adverse cardiovascular events among men using testosterone patches, gels, injections and other TRT treatments. “Unless the FDA immediately begins to provide strong, adequate black-boxed warnings about the risks of heart attacks and other cardiovascular diseases, the continuing toll of heart attacks, many in people who are not even candidates for testosterone, will continue,” the Public Citizen statement warns. “At the present rate of prescribing, almost 13,000 prescriptions a day are filled for testosterone products in this country. Each day of delay of the black box warning ensures much more exposure, too often for men who cannot benefit from the drug but will only be exposed to its risks.”

Contact an Experienced TRT Attorney Today

According to a testosterone treatment study published in January, testosterone replacement therapy may double the risk of heart attack for young men with certain pre-existing heart conditions, and for men over 65 who have no previous heart problems. The researchers involved in the study estimate that for every 1,000 men 65 and older who use testosterone treatments like AndroGel, 11.52 may suffer a heart attack, compared to only 5.27 men per 1,000 who aren’t exposed to low T treatments. If you used AndroGel, Testim or another TRT treatment, and you have since suffered a major side effect like heart attack or stroke, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to helping consumers harmed by potentially dangerous medications, and can help you contact a reputable product liability lawyer who has experience handling testosterone treatment cases.

[box type=”note” align=”aligncenter” ]Source: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0085805[/box]

Posted Under: FDA - Food and Drug Administration, News, Testosterone Replacement Therapy
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