FDA orders label warnings on testosterone drugs concerning normal aging use and heart attack-stroke risks

Pharmaceutical & Medical Packaging News staff in Labels on March 10, 2015
The March 3, 2015, order from the Federal Drug Administration (FDA) that makers of testosterone drugs must change their products' labels to clarify the drugs' intended use and warn about a potential risk of heart attack and stroke is necessary to protect the public from injury from these products, according to Trent Miracle, a partner at Simmons Hanly Conroy.  The order says that the drug makers must indicate on labels that the products – currently taken by millions of U.S. men – are approved only to treat low testosterone levels caused by disease or injury and not to help men deal with normal aging.  "For the last decade, drug manufacturers have been marketing these products, mostly unchecked, allegedly to reverse affects of aging in men. Unfortunately, testosterone replacement therapy is just modern day snake oil," said Miracle, who is co-lead counsel in the federal, multi-district litigation (MDL) involving manufacturers of so-called "Low-T" drug treatments. "We have been litigating these cases for the past year to protect the rights and well-being of people who clearly have been injured by these products."  The FDA order follows an FDA advisory panel's near-unanimous finding last September that there is little evidence that testosterone replacement therapies effectively treat normally decreasing levels of the hormone in aging males. The FDA also ordered drug makers to conduct a broad study of the drugs' cardiovascular risks.  "This is a public safety issue and the FDA appears to finally be getting it right in acknowledging that there's no proof that these products help treat the symptoms for which they are marketed," Miracle added. "The testosterone replacement therapy MDL will help men injured by testosterone treatments receive justice in timely manner."  In February 2014, Simmons Hanly Conroy filed the first low testosterone lawsuits in the country following the FDA's warning about the products.  About Simmons Hanly Conroy, LLCSimmons 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.
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