Simmons Hanly Conroy: AndroGel Makers Revise Testosterone Treatment Drug's Label Following FDA Order to Warn Consumers about Associated Cardiovascular Risks

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May 20, 2015, 04:49 ET

ALTON, Ill., May 20, 2015 /PRNewswire/ -- AbbVie, Inc., the manufacturer of one of the most-used testosterone treatment drugs, has revised the product label for its AndroGel® testosterone gel 1% in response to the Federal Drug Administration (FDA) order that manufacturers must warn consumers about heart attack and stroke risks associated with testosterone replacement therapies.

Testosterone treatment drugs are the subject of lawsuits filed by men throughout the country who suffered strokes, heart attacks and blood clots after using the products. In February 2014, Simmons Hanly Conroy filed the first testosterone replacement therapy lawsuits in the United States, claiming the drug manufacturers failed to warn consumers about the risks.

AndroGel's product label will now include a warning about possible increased risk of major, adverse cardiovascular events associated with use of the product, as well as a statement indicating that the drug is approved only to treat low testosterone levels caused by disease or injury and not to help men deal with normal aging.

The FDA's March 3, 2015, order resulted from its conclusion that there is little evidence that testosterone replacement therapies effectively treat normally decreasing levels of the hormone in aging males, which is how many of the drugs have been marketed – as a way for men to regain their youth or boost energy and sex drive. Also in March, the FDA ordered drug makers to conduct a broad study of the drugs' cardiovascular risks.

"The FDA's order was an important public safety step to force these drug manufacturers to appropriately warn consumers about the adverse side effects from using testosterone treatments," said Trent Miracle, a partner at Simmons Hanly Conroy, who also is the co-lead attorney for the national testosterone replacement therapy litigation. "Millions of men in the United States have used these products to reverse the effects of aging, and many have suffered injuries as a result, having been misled by the drug manufacturers' bogus marketing claims spanning the last decade."

About Simmons Hanly Conroy, LLC

Simmons Hanly Conroy LLC is one of the nation's largest mass tort law firms and has recovered more than $5 billion in verdicts and settlements for plaintiffs. Primary areas of litigation include asbestos and mesothelioma, pharmaceutical, consumer protection, environmental and personal injury. The firm's attorneys have been appointed to leadership in numerous national multidistrict litigations, including Vioxx, Yaz and Toyota Unintended Acceleration. The firm also represents small and mid-size corporations, inventors and entrepreneurs in matters involving intellectual property infringement and business litigation. Offices are located in New York City, Chicago, San Francisco, Los Angeles, St. Louis, and Alton, Ill. Read more at www.simmonsfirm.com.

Contact: Mark Motley, Chief Marketing Officer
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SOURCE Simmons Hanly Conroy