AndroGel™ is an androgen used for replacement therapy in males for conditions associated with a testosterone deficiency. AndroGel™ is marketed by drug maker AbbVie, a spin-off from Abbott Laboratories medicines unit. AndroGel™ 1% was approved by the FDA in 2000, and 1.62% strength was approved in 2011. AndroGel is a gel offered for topical use, and has gone through many label changes. In September 2009, a black box label was placed on the label warning that children exposed to the gel could develop changes in genital size, pubic hair or libido, and show signs of aggressive behavior.
In March 2011, another warning was issued that patients should wait 5 hours before showering or swimming after using AndroGel™. In November 2011, a Medication Guide was issued that discusses the black box warnings of 2009, but fails to warn of the cardiac adverse effects, such as heart attack, stroke and death. In September of 2012, the Medication Guide was updated, but still failed to warn of the cardiac adverse effects. AbbVie offers to provide AndroGel™ 1.62% and 1.0% to patients at no cost through the AbbVie Patient Assistance Foundation.
For almost 20 years, Scott Levensten, Esquire has represented individuals injured by prescription drugs and medical devices, in state and federal courts around the country. The Levensten Law Firm, P.C. earned its reputation as a top plaintiffs’ law firm by achieving over $60 million in recoveries for injured victims in the past 6 years, including a $10 million verdict for a child who was catastrophically injured by a medication. Our firm has the experience, resources and dedicated legal professionals needed to evaluate and pursue your claim for injuries arising out of use of AndroGel.