Thousands of lawsuits have been filed by men who use AndroGel for low testosterone or “Low T” and had a heart attack, stroke, or blood clot. AbbVie is accused of illegally promoting AndroGel as a way to improve health.
UPDATE: $3 Million Awarded in AndroGel Retrial
March 2018 — A man who had a heart attack after using AndroGel testosterone gel has been awarded $3 million by a jury in Illinois. Click here to read more.
AndroGel Lawsuit Ends in $150 Million Jury Award
July 2017 — A federal jury in Chicago has awarded $150 million to a man who suffered a heart attack after using AndroGel testosterone gel for four years. Click here to read more.
Trial Testimony: AndroGel Testosterone Gel Sold Off-Label
June 2017 — In the first “bellwether” trial out of more than 4,200 lawsuits, ex-FDA Commissioner Dr. David Kessler testified that AbbVie illegally marketed AndroGel testosterone gel for “off-label” uses. AbbVie promoted AndroGel as a treatment for “Low T,” a made-up condition involving age-related symptoms like decreased libido, depressed mood, falling asleep at the table, and body fat.
As Dr. Kessler explained: “What the companies in essence did was to take those indications of low testosterone in men for specific reasons [and] the company in essence broke that link.” Click here to read more.
What is AndroGel?
AndroGel is a topical testosterone supplement gel manufactured by AbbVie, formerly part of Abbott Laboratories. It is a clear, colorless gel that may contains 1% or 1.62% concentrations of testosterone, which is a male reproductive hormone. AndroGel is approved to treat “hypogonadism,” a deficiency of testosterone.
Testosterone is a male sexual hormone that is produced in the testicles and regulated in the brain. It is responsible for facial hair, muscle mass, sperm production, and other male sexual characteristics. After age 40, testosterone levels normally decrease by 0.5-1% per year.
FDA Adds Heart Attack, Stroke Warnings to Testosterone Products
March 4, 2015 — In a Safety Communication, the FDA is asking manufacturers of testosterone replacement products to stop marketing them for the treatment of age-related “Low T,” add warnings about heart attacks and strokes, and start studying the long-term risks. Click here to read more.
AndroGel Heart Attack Risk 2X Higher for Men Over 65
Several major studies have linked AndroGel and heart attacks. One of the most recent studies, published in January 2014 in PLoS One, found that men over 65 were twice as likely to have a heart attack if they used testosterone therapy, and men under 65 with pre-existing heart disease were three times as likely to have a heart attack. Click here to read more.
In November 2013, JAMA published a study linking testosterone therapy to a 25.7% risk of cardiovascular side effects, compared to 19.9% for men who were not on the drugs.
Another study, published in 2010 in the New England Journal of Medicine, found that adverse events occurred twice as often in men over 65 on testosterone therapy compared to a placebo, and cardiovascular events were significantly more common.
AndroGel and “Low T”
AndroGel is the most popular treatment for low testosterone, accounting for 75% of prescriptions. You have probably seen advertisements for “Low T,” urging men to seek treatment for a variety of common ailments. According to AbbVie-sponsored advertisements on IsItLowT.com, you probably have Low T symptoms if you are bored, stressed, or aging normally — low libido, less energy, grumpiness, and “falling asleep at dinner.”
Unfortunately, these symptoms are so vague and common, it is tempting for men to self-diagnose themselves. The ads also fail to warn that AndroGel may significantly increase the risk of heart attack, stroke, blood clots, and other deadly side effects. As a result, researchers found that only half of men on testosterone therapy actually have hypogonadism, and nearly 25% never had a blood test before receiving a prescription.
AndroGel Risks & Complications
- Heart attack
- Blood clots
- Pulmonary embolism
- Deep Vein Thrombosis (DVT)
- Venous Thromboembolism (VTE)
- Irregular heartbeat (arrhythmia)
- Heart failure
- Prostate cancer