What is Testim?
Testim is an androgen gel that is applied to the skin, typically on the shoulders or upper arms. Men naturally lose testosterone as they age and according to the manufacturer, Testim is used to increase quality of life through an increased sex drive and enhanced bone mass. It may also be used to improve mood and energy levels. However, the health risk of using Testim is linked to life-threatening side-effects found below.
Testim side effects and complications
- Heart attack
- Blood clot
- Pulmonary embolism
- Transient ischemic attacks
- Sudden death
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.
Certain drug manufacturers have led successful, albeit misleading, advertising campaigns encouraging men to boost their “T-levels” for increased energy and a stronger libido. Although it is unclear if low levels of energy and a dismal sex drive can be supplemented with testosterone, it is clear that the manufacturers have preyed on men’s insecurities in these areas in order to make a profit. Environmental factors, such as stress and sexual arousal, can cause a fluctuation in testosterone levels.
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.”
Drug Safety Communication
The Food and Drug Administration issued a press release in 2015 that announced it would require manufacturers of testosterone products to change their labeling to 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.
Axilium Pharmaceuticals is the second drug manufacturer to face lawsuits alleging misrepresentation of the use of their products. The drugmaker faces a multidistrict litigation in Illinois federal court beginning November 2017.