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Testosterone Therapy Lawsuits: AndroGel Manufacturer Files Petition Against FDA's Decision on Generic Testosterone Treatment Drug
Date:8/26/2014

ered testosterone drug manufacturers to update their testosterone product labels to reflect the risk of heart attack, stroke, blood clots in the lungs or legs, and increased or irregular heart rate linked with the use of testosterone medication. In August, a class action AndroGel testosterone lawsuit was filed in Canada against AbbVie Products LLC and Abbott Laboratories Ltd., which manufactures and markets AndroGel. The lawsuit contends that Abbott knew, or should have known, the risks associated with using AndroGel and failed to warn the public. The news release issued by the law firms that filed the AndroGel claim said this is the first testosterone replacement therapy class action starting in Canada. (London, Ontario, Canada (Court File No. 3704CP/14))
[healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/40587a-eng.php, July 15, 2014]
[marketwatch.com/story/androgel-testosterone-replacement-therapy-class-action-commenced-in-canada-2014-07-24, July 24, 2014]

In January, the FDA announced it was re-evaluating the safety of prescription testosterone replacement therapy drugs after reviewing two observational studies that showed potential cardiovascular problems associated with taking low testosterone medication. A study published in the November 2013 Journal of the American Medical Association found that older men who had an underlying cardiovascular disease and took testosterone replacement therapy had a 30 percent increased risk of a stroke, heart attack or death compared to men who did not take the medication. The second study reviewed by the FDA was published in the PLOS One Journal in January 2014. This study found that men over 65 and younger men with a pre-existing heart disease who were prescribed testosterone drugs were at a greater risk of having a heart attack within the first 90 days after taking the medication for the first time.
[jama.jamanetwork.com/article.aspx?articleid=1764051, November 6, 2013] [fda.gov/Drugs
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