Androgel Lawsuit ™

AndroGelâ„¢ Linked to Heart Attack, Stroke and Death In Men

A recent clinical trial of testosterone therapy in men with heart disease was abruptly stopped early because of life threatening adverse events, including strokes, heart attacks and death. After the study was halted, another study was conducted looking at data in a Veterans Affairs tracking system, rather than exposing subjects to the deadly risks in an actual clinical trial.

The results of the VA study were published on November 6, 2013. Of the 1,223 patients in the VA system receiving testosterone therapy, 67 died, 23 had MIs and 33 had strokes. The rate of events in the testosterone therapy group was 25.7%. Those receiving the drug had a 5.8% greater risk than those not receiving the drug at 3 years after coronary angiography. The investigators concluded that the men who underwent coronary angiography and had low serum testosterone level were at an increased risk of adverse outcomes.

Prior clinical trials appear to be insufficiently designed to detect the risk. The investigators in the VA study concluded that the premature termination of the trial and the limitations of prior studies highlight the uncertainty regarding the safety of testosterone therapy drugs, like AndroGel™.
 
 

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AndroGel™ Side Effects


Side Effects in Men

Heart Attack
Ischemic Stroke
Death
Breathing Problems
Blood Clots
Mood Swings


VA Study Statistics

AndroGel VA Statistics


Increased Risk of Injury or Death

AndroGel Side Effects

History of AndroGel™

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.

Contact

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.

Call: 1-800-510-1325