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Schachter, Hendy & Johnson, Attorneys At Law

FDA Requires Labeling Changes for Testosterone

Sarah N. Emery
Associate Attorney at Schachter Hendy & Johnson PSC
Posted on Mar 03, 2015

The FDA announced that all testosterone medications, including AndroGel, will be required to warn about the risks of heart attack and stroke associated with testosterone. The FDA is also cautioning that these medications "have not been shown to help men with low testosterone levels reverse the aging process."

Canada Health issued a similar warning approximately 7 months ago. Sid Wolfe of Public Citizen states, "The delay is inexcusable. It's not in the service of the public health to delay so long in issuing such a warning." According to Wolfe, "If the FDA had acted when Canada did, some of those people may have been protected."

Testosterone medications have been promoted as helping to boos sex drive, moods and energy levels. This marketing helped double usage between 2010 and 2013 and in 2014, an estimated 2.3 million U.S. men were taking testosterone.

Schachter Hendy & Johnson Attorney Ron Johnson, one of 3 national co-leads in this litigation was quoted as stating "These products are not the 'fountain of youth' they are sold to be and, instead, they are causing serious injuries, which the FDA recognized and acknowledged today."

If you or a loved one suffered a heart attack, stroke, pulmonary embolism, deep vein thrombosis or blood clots while taking testosterone, please contact our experienced AndroGel attorneys for a free consultation about your potential testosterone lawsuit.

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