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The side effects of AndroGel and other testosterone treatments may increase the risk of heart attacks, strokes and sudden death. As a result of drug manufacturers’ failure to adequately warn about the serious and potentially life-threatening heart risks, former users may be entitled to financial compensation through a testosterone therapy lawsuit.
TESTOSTERONE LAWSUIT STATUS: Product liability lawsuits are being reviewed by testosterone therapy injury lawyers on behalf of men throughout the United States who have suffered a:
- Heart Attack
- Blood Clots (Deep Vein Thrombosis (DVT) or Pulmonary Embolism
- Wrongful Death
The makers of Axiron and Testim have tentatively agreed to testosterone settlement agreements to resolve those cases. The details of those settlements have not been revealed.
OVERVIEW: Testosterone therapy is used to treat men suffering from testosterone deficiencies, which can negatively affect muscle mass, sex drive and energy levels. The condition, known as hypogonadism, results in lower strength, reduced energy and diminished sexual function. However, research has suggested that many men taking testosterone gels, injections or other treatments may not have a medical need for the hormone replacement therapy, and may actually be exposing themselves to an increased risk of heart attack, stroke or death.
Use of Androgel, AndroDerm, Axiron and other testosterone treatments has increased more than five times from 2000 to 2011, generating more than $1.9 billion in sales in 2012. These products deliver testosterone in a variety of ways, including:
- Testosterone Gel: AndroGel, Axiron, Bio-T Gel, Foresta and Testim
- Testosterone Patch: AndroDerm
- Testosterone Injection: Delatestryl, Depo-Testosterone
- Testosterone Implant: Testopel
- Testosterone Pill: Striant
TESTOSTERONE HEART RISKS: Recent research suggests that side effects of testosterone therapy can increase the risk of heart attacks and strokes in certain men.
A study published by the Journal of the American Medical Association (JAMA) in November 2013 highlighted the potential heart attack, stroke and death risk of testosterone replacement treatments. Researchers from the Veteran Affairs Eastern Colorado Health Care System in Denver found that the rate of cardiovascular events was 25.7% among men who took testosterone therapy drugs, compared to a rate of 19.9% among those who did not. Out of 1,223 patients on testosterone, researchers discovered that within a year and a half, 67 had died, 23 suffered heart attacks and 33 had strokes.
On March 3, 2015, the FDA issued a drug safety communication calling for new label warnings for all prescription testosterone drugs. The new warning labels will include a warning that testosterone drugs may increase the risk of cardiovascular problems, including heart attacks and strokes.
The labels will also be updated to warn that testosterone drugs are approved only for use in men who have been diagnosed with hypogonadism following at least two testosterone serum tests. The FDA is also requiring all testosterone drug manufacturers to conduct new clinical trials to determine the low-t drug cardiovascular risks.
In August 2015, FDA researchers officials called for the industry to prove that the drugs help men who do not have “classic hypogonadism” without increasing their risk of heart attacks and strokes, indicating that the drug makers should work together on new clinical trials in a study published in the New England Journal of Medicine.
Another study published in JAMA in February 2017 appeared to provide more evidence that AndroGel use was linked to an increased risk of heart attacks and strokes.
There are also concerns about the accidental exposure of women and children to testosterone gel. Critics say that some delivery methods increase the risk that women and children may be exposed. Testosterone gel side effects may cause children to undergo puberty early, experience changes to sexual organs, increased libido and aggressive behavior, as well as advanced bone age. It can also change the distribution of body hair.
In July2017, the first testosterone lawsuit to go before a jury resulted in a $150 million verdict for the plaintiff. A second case in October 2017 resulted in a $140 million verdict for the plaintiff.
In December 2017, Eli Lilly announced that it had agreed to settle all Axiron claims.
In March 2018, the Endocrine Society released new guidelines on the use of testosterone products. The guidelines call for doctors to use more caution in prescribing testosterone replacement therapy, and calls for additional testing to confirm that men have hypogonadism before being prescribed the medications.
TESTOSTERONE BLOOD CLOT SIDE EFFECTS: Research has also established that testosterone side effects may cause men to face an increased risk of serious and potentially life-threatening blood clots, including a deep vein thrombosis (DVT) or pulmonary embolism.
While warnings about the potential link between testosterone and blood clots have been known for some time, prior warnings indicated that the risk may be caused by a problem known as polycythemia, an abnormal increase in red blood cells. However, in June 2014, the FDA determined that stronger testosterone warnings for the blood clot risks were needed.
Makers of all testosterone drugs were required to update the label warnings to include information about the more general risk of venous thromboembolism, which may include clots that develop in the veins. If these clots from testosterone develop in the deep veins of the legs, known as a deep vein thrombosis (DVT), they pose a serious risk if they break free. This could result in a pulmonary embolism if the clot travels to the lungs or other life-threatening injury.
FIND OUT IF YOU MAY QUALIFY FOR A TESTOSTERONE LAWSUIT: As a result of the manufacturers’ failure to adequately warn about the potential testosterone side effects, financial compensation may be available for men who suffered a heart attack, stroke or wrongful death. Potential claims may also be available for children who have suffered secondary testosterone exposure.
Free consultations and claim evaluations are provided by lawyers who are reviewing potential testosterone injury lawsuits throughout the United States.