Plaintiffs’ Executive Committee on the Testosterone Replacement Therapy MDL: FDA Cracks Down on Testosterone Products

Statement from Ron Johnson, co-lead counsel representing thousands of plaintiffs as part of multi-district litigation in Chicago against the makers of testosterone replacement therapy products, including industry leaders AbbVie and Eli Lily and their products AndroGel and Axiron:

The U.S. Food and Drug Administration (FDA) issued new labeling indications for testosterone replacement therapy (TRT) products today, finding that manufacturers of approved testosterone products change their labeling to clarify approved uses after a FDA advisory committee recommended changes last September that would crack down on the prescribing of testosterone for natural, age-related testosterone decline and include warnings about the risk of cardiovascular injuries with TRT use.

“This labeling change mandated by the FDA is a necessary and welcomed one, given the dire need of increased oversight and regulation for testosterone products. Following deceptive marketing campaigns, thousands of product users sought out treatment for a fictitious condition the manufacturers of these products called ‘Low T’. 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. This product has no place in the lives of men with normal, age-related testosterone loss – and the industry that perpetrated that lie needs to be held accountable.”

Annual prescriptions for testosterone replacement therapy have boomed in the past decade, increasing by more than five-fold from 2000-2011 to reach 5.3 million prescriptions and a market of $1.6 billion in 2011. In 2012 alone, AbbVie recorded $1.2 billion in annual sales of AndroGel. That same year, Eli Lilly made more than $200 million in annual sales for Axiron (2012 AbbVie Annual Report; Acrux Investor Presentation).

Labeling for testosterone medications was already changed by the FDA in June 2014 to reflect the risk of blood clotting injuries, including deep vein thrombosis and pulmonary embolism. Lawsuits filed across the nation for men injured by testosterone products are being consolidated in a multi-district litigation before Judge Matthew Kennelly in the Northern District of Illinois.

Click here for information from the FDA: http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm