Men are experiencing serious and life-threatening health conditions due to the use of Axiron, a testosterone replacement therapy (TRT) manufactured by Eli Lilly & Co. Recent studies have linked to usage of Axiron to a number of injuries including heart attack, strokes, pulmonary embolisms, and deep vein thrombosis (“DVT”).
What is Axiron?
Axiron is a topical testosterone solution that is applied under the armpits. It is intended for men to use who have little to no testosterone levels due to medical conditions; not due to the natural decline in testosterone from aging. Most men start to experience a decline in testosterone levels after age 40.
Side effects of Axiron
- Pulmonary embolism
- Deep vein thrombosis
- Venous thromboembolism
- Heart attack
- Transient ischemic attacks (mini-strokes)
- Brain damage
What is testosterone replacement therapy (TRT)?
Testosterone replacement therapy (TRT) is a lucrative business for manufacturers of Axiron. Testosterone is a hormone that is produced in the testicles. It helps to maintain muscle strength and mass, facial and body hair, fat distribution, bone density, libido, sperm production and red blood cell production.
What conditions is TRT used to treat?
Some men suffer from conditions such as hypogonadism; which is where the body doesn’t produce enough testosterone. Males can be born with hypogonadism or they are diagnosed with it after a serious illness or injury. Therefore age does not play a role in a diagnosis.
Studies show an increased risk of cardiovascular complications
The Journal of the American Medical Association (JAMA) published their findings from a study in November 2013 that testosterone supplements caused a significant increase in cardiovascular complications. Researchers discovered that stroke, heart attack and sudden death, were among 25.7% of TRT candidates versus 19.9% of those who did not participate in the treatment. Within a year and a half, researchers determined that 23 participants suffered heart attacks, 33 had strokes and 67 died from participating in testosterone supplementation.
Public Awareness Campaigns
Consumer advocacy groups, such as Public Citizen, perform content-awareness campaigns so consumers can make informed decisions. In a 2014 press release, Public Citizen wrote that studies conducted by the drug companies showed no increased risk of cardiovascular complications from using TRT products. However, in multiple outside studies, there was a significant increased risk in cardiovascular complications from using TRT products.
According to Public Citizen, “More than five million U.S. prescriptions for testosterone products were filled in 2013. The most common of those, making up more than 90 percent of the testosterone prescriptions filled in 2013, include Androgel, Axiron, Testim and Fortesta.”
Updates from the FDA
The Food and Drug Administration issued a press release in 2015 that required manufacturers of testosterone products to change their labeling and indicate that use of testosterone products carries an increased risk of heart attack, stroke and death.
Also mentioned in the press release was the acknowledgement that testosterone replacement therapy has been used to treat conditions other than what it was initially made for. “[The] FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging.”
Multiple lawsuits accuse the makers of testosterone replacement medicines of hiding or downplaying their products’ risk for blood clots, heart attack and stroke, and violating federal law with aggressive marketing campaigns. In July 2017, a jury awarded $150 million in punitive damages stemming from the Plaintiff’s claim that the makers of AndroGel, a different TRT product, fraudulently mismarketed the drug to consumers. Later that fall, a different jury found AndroGel caused the Plaintiff to suffer a heart attack and awarded the man $140,000 in compensatory damages and $140 Million in punitive damages.