Men who take the testosterone supplement AndroGel have an increased risk of suffering a heart attack, stroke or other cardiovascular event, according to a recent study. Androgel warning labels list a number of potential health consequences including high blood pressure (hypertension), blood clots, and ‘serious problems’ for men with a history of heart, kidney or liver disease.
Free Confidential Case 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 lawsuit and our lawyers can help.
What is AndroGel?
Made by Abbvie, Inc. (an Abbott Laboratories company), AndroGel is prescribed for replacement therapy in men with lowered testosterone levels. AndroGel 1% was approved by the FDA in 2000, and 1.62% strength was approved in 2011. The product is a gel designed to be applied topically, and has gone through several label changes since it first hit the market.
How Does it Work?
In men with lowered testosterone levels (“Low T”), AndroGel increases the total amount of circulating testosterone in the body to a normal range found in healthy men. According to the drug insert (PDF), this measurement is roughly between 298 – 1043 ng/dl. In men who use lotion or sunscreen, the amount of testosterone absorbed increases.
After applying AndroGel, users should wash their hands thoroughly with soap and water. It is also important to understand that the product is flammable until dry, and patients should avoid flames, smoking or fire.
What’s the Problem?
The TRT industry is more profitable than ever, with annual sales topping $2 billion in the United States alone. The testosterone supplement industry is expected to hit $5 billion by 2017, due largely to aggressive direct-to-consumer advertising campaigns that push AndroGel and other similar products on middle-aged and older men.
“The market for testosterone gels evolved because there is an appetite among men and because there is advertising,” said Dr. Joel Finkelstein, an associate professor at Harvard Medical School. “The problem is that no one has proved that it works, and we don’t know the risks.”
Testosterone Replacement Therapy (TRT) Linked to Cardiac Side Effects
As men age, their testosterone levels decrease slowly over time, and many turn to ‘Low T’ supplements as a solution. However, research published in the Journal of the American Medical Association (JAMA) found that men who take testosterone boosters like AndroGel are 30% more likely to suffer a stroke or other cardiac side effects compared to men who did not take the supplements. The study’s authors identified a link between testosterone and the following adverse health complications:
- Stroke – Condition in which the brain cells suddenly die because of a lack of oxygen.
- Pulmonary embolism – Sudden blockage in a lung artery typically caused by a clot that travels to the lung from a vein in the leg.
- Myocardial infarction – Commonly known as a heart attack, this condition occurs when blood stops flowing properly to part of the heart and the heart muscle is injured due to not receiving enough oxygen.
- Arrhythmia – Irregular heartbeats
- Transient ischemic attacks – Transient episode of neurologic dysfunction caused by ischemia (loss of blood flow) – either focal brain, spinal cord or retinal – without acute infarction (tissue death).
These AndroGel side effects cause tremendous suffering, both for the man affected as well as his family. Additionally, the medical expenses associated with AndroGel injuries can be staggering, and may threaten the family’s financial future. This is why you may wish to consider legal action if you’ve suffered a serious injury after taking AndroGel.
AndroGel Black Box Warning
In September 2009, the U.S. Food & Drug Administration (FDA) announced that it was requiring a ‘black box’ warning (PDF) to be affixed to AndroGel labels stating that children exposed to the drug could experience changes in genital size, pubic hair or libido, and unusually aggressive behavior. Two years later, in March 2011, another warning was issued stating that men using AndroGel should wait 5 hours before showering or swimming after applying it. Then in November 2011, a Medication Guide (PDF) was released that discussed the earlier black box warnings, but which failed to warn of the risk of heart attack, stroke and death.
AndroGel Side Effects
Severe side effects of AndroGel may include:
- Heart attack
- Blood clot
- Pulmonary embolism
- Transient ischemic attacks
- Sudden death
Other, less severe side effects of AndroGel may include:
- Hair loss
- Trouble sleeping
- Change in sexual desire
- Redness/swelling of the skin
- Change in skin color
Testosterone Prescriptions Issued Without Test
The Journal of the American Medical Association study mentioned above also reported that about 25% of men who received prescriptions for testosterone boosters were granted them without undergoing blood tests to check their testosterone levels. The research also determined that testosterone users were almost 30% more likely to experience a heart attack, stroke, or die suddenly than men who did not use the products.
Are Lawsuits Being Filed?
In February 2014, a group of 5 men (ages 50-63) filed a product liability lawsuit against Abbott Laboratories and AbbVie, Inc., alleging injuries from AndroGel. According to the suit, 3 of the men had a heart attack and 2 suffered strokes. The complaint was filed in the U.S. District Court for the Northern District of Illinois.
The plaintiffs included 54-year-old Michael Gallagher, who suffered myocardial infarction, congestive heart failure and other injuries after using AndroGel. He had no history of cardiac problems before taking the drug, and claims he started AndroGel therapy after the defendants’ advertisements led him to attribute symptoms of normal aging to low testosterone.
According to the complaint, Abbott and AbbVie “deceived potential users by relaying positive information through the press, including testimonials from retired professional athletes” and statistics suggesting a widespread need for the drugs, “while downplaying known adverse and serious health risks.”
Testosterone Multidistrict Litigation (MDL)
In June 2014, a panel of judges ruled that federal lawsuits against the makers of AndroGel and other testosterone replacement therapy products would be centralized in a multidistrict litigation (MDL) in the U.S. District Court of Illinois before Judge Matthew F. Kennelly.
“Centralization of claims involving all testosterone replacement therapies will reduce potentially costly expert discovery, facilitate the establishment of a uniform pretrial approach to these cases, reduce the potential for inconsistent rulings . . . and conserve the resources of the parties, their counsel and the judiciary,” the U.S. Judicial Panel on Multidistrict Litigation (JPML) wrote in announcing the consolidation.
At the time of the announcement, at least 45 complaints had been filed against Abbott Laboratories and Abbvie over AndroGel. It has been estimated that thousands of claims may eventually be included in the MDL by the time lawsuits against other TRT manufacturers like Eli Lilly (Axiron), Watson Laboratories (Androderm) and others are consolidated.
Do I Have an AndroGel Lawsuit?
The Product Liability & Defective Drug 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 AndroGel injury and death lawsuits in all 50 states.
Free AndroGel Lawsuit 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.
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