Men who use the testosterone replacement therapy (TRT) product AndroGel face an increased risk of stroke and heart attack, according to the results of a new study. Androgel warning labels list a number of serious side effects including high blood pressure, blood clots in the legs, and ‘serious problems’ for patients with pre-existing heart, kidney or liver disease.
Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by AndroGel, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: Chicago Jury Orders AbbVie to Pay $150 Million Over AndroGel Side Effects
July 27, 2017 – AbbVie Inc. must pay $150 million to an Oregon man who accused the company of failing to warn about the safety risks of AndroGel, a federal jury in Chicago has decided. The jury took the unusual step of awarding Plaintiff Jesse Mitchell $150 million in punitive damages, meant to punish AbbVie, but nothing in compensatory damages for his personal injuries.
What is AndroGel?
Manufactured and marketed by Abbvie (a subsidiary of Abbott Laboratories), AndroGel is an androgen used for replacement therapy in men with testosterone deficiency. AndroGel 1% was approved by the U.S. Food & Drug Administration (FDA) in 2000, and 1.62% strength was approved in 2011. The product is a gel formulation offered for topical use, and has gone through a number of label changes over the years.
AndroGel Linked to Cardiac Side Effects
Testosterone replacement therapy is more profitable today than ever before, with sales of prescription patches, topical gels and creams topping $2 billion in 2012 alone. The TRT industry is expected to hit $5 billion within the next five years, due in large part to an aggressive marketing campaign that pushes AndroGel on middle-aged men.
Men in this age range face naturally-occurring diminished testosterone levels, and many turn to prescription treatments to reinvigorate themselves. However, a recent study published in the Journal of the American Medical Association (JAMA) indicates that men who use testosterone boosters like AndroGel are 30% more likely to suffer a stroke or other severe cardiac complications than non-users. Researchers found testosterone supplements to be correlated with an increased risk for:
- Stroke – Occurs when a blood clot gets stuck in the brain, restricting the supply of oxygen
- Pulmonary embolism (PE) – Blood clot lodged in the lungs
- Deep vein thrombosis (DVT) – Blood clot in the legs
- Venous thromboembolism (VTE) – Combination of PE & DVT
- Heart attack
- Deep vein thrombosis – Blood clot in the legs
- Arrhythmia – an irregular heartbeat
- Transient ischemic attacks – commonly referred to as ‘mini-strokes’
- Brain damage
These AndroGel complications can cause tremendous suffering, not only for the man affected, but for each of his family members as well. Additionally, the medical costs associated with AndroGel injuries are likely to be staggering, and may threaten the entire family’s financial future. This is why you may wish to consider legal action if you’ve been adversely affected by AndroGel side effects.
First AndroGel Bellwether Ends in Mistrial
June 19, 2017 – The first attempt to hold AbbVie Inc. responsible for the side effects alleged from AndroGel has ended in a mistrial after the lead plaintiff’s attorney suffered from heart problems. Court documents indicate that the man was hospitalized with heart complications on June 10 and underwent an unspecified procedure, but has since been released and is now recovering back home.
FDA Requires Heart Attack, Stroke Warning to be Added to AndroGel Labels
March 3, 2015 – FDA issued a press release today announcing label changes that will be applied to all approved prescription testosterone supplements. The updated labeling warns that testosterone has been linked to heart attack, stroke, and other severe cardiovascular side effects, and that the supplements should not be prescribed to men for the sole purpose of treating symptoms associated with the normal aging process. Click here to learn more.
FDA Black Box Warning on AndroGel
In September of 2009, the Food & Drug Administration required that a black box warning be placed on AndroGel labels stating that children exposed to the product could experience changes in genital size, pubic hair or libido, and become unusually aggressive. Two years later, in March 2011, another warning was issued stating that AndroGel users should wait at least five hours before showering or swimming after applying the product. Then in November 2011, a Medication Guide was issued that discussed the earlier black box warnings, but which failed to warn of potential cardiac side effects such as heart attack, stroke and death.
AndroGel Side Effects
Severe side effects of AndroGel include:
- Heart attack
- Blood clot
- Pulmonary embolism
- Transient ischemic attacks
- Sudden death
Other, more moderate side effects may include:
- Hair loss
- Trouble sleeping
- Change in sexual desire
- Redness/swelling of the skin
- Change in skin color
Men Receiving Testosterone Prescriptions Without Test
The JAMA study mentioned above also reported that approximately 25% of men who were issued prescriptions for testosterone replacement therapy were granted the prescription without having blood tests to check their testosterone levels. The study also that found men who took testosterone boosters were nearly 30% more likely to suffer a heart attack, stroke, or die suddenly compared to men who did not take the supplements.
Testosterone and Prostate Cancer
Two recent studies found that testosterone raised the risk of prostate tumors and worsened the effects of carcinogenic chemical exposure in laboratory rats. Researchers administered testosterone to the animals through slow-release implants. Before the rats were dosed, some were injected with the carcinogenic chemical N-nitroso-N-methylurea. Among the rats that received testosterone without this chemical, 10 to 18% developed prostate carcinomas. When rats were exposed to testosterone and the carcinogen, 50 to 71% developed prostate cancer. Rats that were exposed to the carcinogenic chemical but not testosterone did not develop the disease.
“This research demonstrates that testosterone on its own is a weak carcinogen in male rats,” said study author Maarten Bosland from the University of Chicago. “When it is combined with cancer-causing chemicals, testosterone creates a hospitable environment for tumors to develop. If these same findings hold true in humans, there is serious cause for public health concern.”
Type 2 Diabetics with “Low T” may have Increased Risk of Heart Disease: Study
A recent study conducted in Argentina found that men who have low testosterone levels — along with type 2 diabetes — have an increased risk of developing heart disease compared to diabetics with normal T levels. Researchers at Universitario Sanatorio Guemes Hospital identified a link between low concentrations of testosterone and atherosclerosis, a cardiovascular disease that occurs when artery walls thicken due to the accumulation of white blood cells. Click here to learn more.
Testosterone Warning Labels Updated to Reflect Addiction Risk
January 18, 2017 – The warning labels of all prescription testosterone supplements is being updated to include information about a risk of abuse and dependence. FDA also warned that high doses of testosterone can lead to serious adverse events affecting the heart, liver, brain, mental health and endocrine system.
First AndroGel Heart Attack, Blood Clot Lawsuits To Go To Trial Late 2016: Judge
Coordinated litigation involving injuries allegedly caused by AndroGel continues to move forward in Illinois federal court, with early trials tentatively scheduled to begin in late 2016. A case management plan created by the judge overseeing the litigation outlines a process by which bellwether trials will be selected and a potential calendar for trial dates. Click here to learn more.
Bellwether Trials Selected in AndroGel MDL
September 2, 2016 – U.S. District Judge Matthew Kennelly has selected 8 lawsuits to move forward as bellwether trials in the testosterone MDL in the Northern District of Illinois. Of the 8 suits designated as bellwether trials, 4 allege claims of myocardial infarction (heart attack) or stroke, and 4 involve venous thromboembolism (VTE). All 8 cases, however, involve injuries alleged from AndroGel.
Indiana Woman Seeks Damages in AndroGel Wrongful Death Lawsuit
March 30, 2016 – An Indiana woman whose husband allegedly died from a heart attack after using AndroGel has filed a product liability lawsuit against AbbVie Inc. and Abbott Laboratories. According to the complaint, which was filed in the U.S. District Court for the District of Indiana, the man died of a massive heart attack in 2014 after taking AndroGel to treat his hypogonadism for about 4 years. Plaintiff alleges that neither her husband nor his doctors could have been aware of the risks associated with AndroGel because the manufacturers failed to adequately warn about these potential side effects.
AndroGel Bellwether Trial Selection Amended
June 2, 2015 – The court overseeing the federal AndroGel litigation has amended the Case Management Order governing selection for the upcoming bellwether trials, which may provide insight into how juries will rule in similar cases. The amended order directs the parties to submit a Proposed Case Management Order by August 10, which outlines parameters for selecting AndroGel plaintiffs in 2 tiers of lawsuits: 1) clotting injuries, and 2) cardiovascular complications such as heart attacks. Click here to learn more.
AndroGel Lawsuit Allegations
- AbbVie misrepresented AndroGel as safe and effective
- Marketing campaigns ignored potential risks of AndroGel treatment
- AbbVie placed sales ahead of adequate warnings
Additional Resources & Information
- First Status Conference Scheduled in Testosterone Lawsuit Multidistrict Litigation
- Judicial Panel Denies Pfizer’s Attempt to Exclude Depo-Testosterone Lawsuits from Consolidation
- FDA Requests Blood Clot Warnings on Labels of Testosterone Supplements
- Public Citizen Calls for Black Box Warning on Testosterone Supplements
- Pfizer Argues Testosterone Lawsuits Should Be Limited to Gel Formulations
Do I Have an AndroGel Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in AndroGel Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Evaluation: Again, if you or a loved one has been injured by AndroGel, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.