AndroGel
Men who use AndroGel and other low-T treatments may face an increased risk of heart attack, stroke, blood clots, pulmonary embolism, and death. Concerns over the cardiac side effects associated with prescription testosterone treatments have already prompted warnings from the U.S. Food & Drug Administration (FDA), as well as thousands of lawsuit filings on behalf of men who were allegedly injured due to AndroGel and similar medications.
AndroGel Lawsuit Reviews
Men who experienced heart attacks, strokes and other serious cardiovascular events while using AndroGel may be entitled to compensation for their physical, emotional and financial damages. To learn if you might qualify to file an AndroGel lawsuit, please contact Bernstein Liebhard LLP at (888) 994-5118 to obtain a free, no-obligation legal review.
What is AndroGel?
AndroGel is a topical testosterone gel applied to the skin. It is indicated to treat primary hypogonadism (low testosterone) related to an underlying medical condition, such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. AndroGel is also approved to treat hypogonadism caused by gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
AndroGel is manufactured by AbbVie, formerly part of Abbott Laboratories. It is available in 1.00% and 1.62% concentrations.
Testosterone Safety Under Scrutiny
- November 2013: A scientific paper published in JAMA suggests that use of prescription testosterone treatments is associated with a 25.7% risk of cardiovascular side effects, compared to 19.9% for men who were not on the drugs.
- January 2014: A study publishes in PLoS One found that men over 65 were twice as likely to have a heart attack if they used low-T treatments, while men under 65 with pre-existing heart disease were three times as likely to have a heart attack if they used the drugs.
- January 2014: The FDA announced it was reviewing the safety of AndroGel and other low-T therapies amid concerns that the drugs might increase the risk of heart attacks and strokes in certain men.
- June 2014: The FDA orders new blood clot warnings for AndroGel and other prescription testosterone treatments, including pulmonary embolism and deep vein thrombosis. Read More
- March 2015: The FDA completes the review announced in January 2015, and orders low-T manufacturers to add new warnings to their product labels regarding a possible association with heart attacks and strokes. Read More
Drug Makers Under Fire for Low-T Marketing
AndroGel and other testosterone treatments are not approved for use in men who suffer from low testosterone levels that are merely the result of aging. However, a growing number of plaintiffs claim that the drugs’ manufacturers have long engaged in misleading marketing that characterized low-T therapy as an appropriate treatment for fatigue, weight gain, muscle loss and other aging-related issues.
In its March 2015 safety communication, the FDA said it would require the manufacturers of low-T medications to state clearly that the medications have not been proven safe and effective in treating hypogonadism related to age-related drops in testosterone. The agency noted that the use of testosterone replacement therapy has increased significantly, from 1.3 million patients in 2009 to 2.3 million patients in 2013 receiving a prescription for a testosterone product. The FDA expressed concern that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging.
That same month, two medical researchers writing in the Journal of the American Geriatrics Society accused the manufacturers of AndroGel and other prescription testosterone treatments of utilizing questionable methods to drive sales of the medications. One of the authors told Forbes.com that pharmaceutical companies “market the idea that men go through something similar to menopause, where they have these marked declines in testosterone and all these symptoms that we normally attribute to aging.” Read More
FTC Files AndroGel “Pay-for-Delay” Lawsuit
The Federal Trade Commission (FTC) is currently pursuing a “pay-for-delay” lawsuit against the manufacturers of AndroGel. Among other things, the Commission claims that AbbVie, Inc. filed sham lawsuits against certain generic drug makers in order to block generic versions of AndroGel from coming to market. On June 30, 2016, the FTC filed a motion with the U.S. District Court, Eastern District of Pennsylvania, seeking certain AbbVie board materials, and asserted that the company has been stalling on the matter for months. Read More
Testosterone Litigation Update
- December 2015: The multidistrict litigation involving thousands of testosterone lawsuits is moving ahead with a bellwether trial plan involving AndroGel lawsuits. Per an Order issued in the U.S. District Court, Northern District of Illinois, up to 12 AndroGel claims will head to juries in 2017. Trial dates are as follows: April 21, 2017; June 5, 2017; July 10, 2017; August 21, 2017; September 25, 2017; and November 6, 2017. Read More
- June 2014: Federal testosterone lawsuits filed on behalf of men who allegedly suffered heart attacks, strokes and blood clots due to their use of AndroGel and other low-T therapies are centralized in the U.S. District Court, Northern District of Illinois. Read More
- April 2014: Plaintiffs who have filed AndroGel lawsuits and other testosterone claims over the drugs’ alleged cardiovascular side effects seek the creation of a multidistrict litigation for all federal claims in a single U.S. District Court. In a motion filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML), they argue that centralization is appropriate because the lawsuits pose common questions of law and fact, and consolidation or coordination before one court will ensure efficient management of the litigation and avoid duplicative discovery. Read More
Legal Help for Those Harmed by AndroGel
If you or a man you care about suffered a heart attack, stroke or dangerous blood clot while using AndroGel, now is the time to ensure your legal rights are protected. To learn more about the growing testosterone litigation, please call (888) 994-5118.
- FDA (2015) “AndroGel Medication Guide” http://www.fda.gov/downloads/drugs/drugsafety/ucm255313.pdf
- JAMA (2013) “Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels” http://jama.jamanetwork.com/article.aspx?articleid=1764051
- PLoS One (2014) “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men” http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0085805
- FDA (2014) “FDA Drug Safety Communication: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products” http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm
- FDA (2014) “FDA adding general warning to testosterone products about potential for venous blood clots” http://www.fda.gov/Drugs/DrugSafety/ucm401746.htm
- FDA (2015) “FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use” http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm
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