Testosterone therapy, which is FDA approved to boost male sex hormone levels in men with hypogonadism, has been marketed as more of a lifestyle product to men experiencing the normal effects of aging. In 2012, manufacturers Abbot Laboratories and AbbVie spent more than $80 million advertising Androgel – one of the most popular testosterone supplements currently on the U.S. market. Their ad campaign targets middle age men with a “Low T” symptoms checklist that asks:
- Has your sex drive diminished?
- Have you been feeling moody?
- Do you have less energy?
- Are you experiencing decreased muscle mass and strength?
Doctors say that less energy, a waning libido and increased body fat are normal facets of the aging process and that low testosterone or “Low T” as it has been coined by the industry is a largely invented condition. Testosterone levels naturally start to drop in men after the age of 30, and estimates show that less than 50 percent of patients taking Androgel and other testosterone products have actually been tested for and diagnosed with hypogonadism. Millions of men now use Low T supplements, which have questionable medical benefits and carry dangerous side effects, including an increased risk for heart attacks and stroke. According to an article by Drug Reporter, studies have shown a link between testosterone use, and heart attack, stroke and other serious health complications.
Deceptive testosterone therapy marketing tactics
Androgel is one of the best-selling testosterone replacement supplements in America but other products – sold as skin patches, creams, injections and gels include Axiron, Fortesta, Striant, Tesopel, Testim, Bio-T Gel and Androderm. Low T supplements have been promoted as a veritable fountain of youth in direct-to-consumer ads, which many in the medical community view as misleading and deceptive. “The market for testosterone gels evolved because there is an appetite among men and because there is advertising . . . The problem is that no one has proved that it works and we don’t know the risks,” Harvard Medical School professor Dr. Joel Finkelstein told The New York Times in 2013. Recent product liability lawsuits filed against Abbott Laboratories and AbbVie Inc. allege that the companies “deceived potential AndroGel users by relaying positive information through the press, including testimonials from retired professional athletes…while downplaying known adverse and serious health risks.” The first wave of Androgel lawsuits, brought in 2014, came on the heels of an FDA announcement that regulators would be re-examining the risks of testosterone replacement supplements after research suggested a higher risk of strokes and cardiovascular injury in certain populations of men who used them.
Testosterone side effects and increased heart attack risk
One of the most worrisome studies on testosterone risks was published in the PLoS One medical journal in January 2014. Researchers found that men aged 65 and older as well as younger patients with previously undiagnosed heart disease had twice the risk of suffering a heart attack from testosterone therapy after just three months. A separate study published in the New England Journal of Medicine found that topical application of testosterone gel can raise the risk of myocardial infarction, stroke and atrial fibrillation in older men. Men using Low T products have also experienced transient ischemic attacks (TIA), also known as mini-strokes, which are known precursors to strokes in about 30 percent of patients. Strokes and adverse cardiovascular events are just a couple of the life-threatening side effects linked to testosterone replacement therapy. Other reported side effects include:
- Sleep apnea
- Increased risk for prostate cancer
- Pulmonary embolism – a potentially deadly blood clot in the lungs
- Paroxysmal Ventricular Tachycardia (PVT – rapid heart rate)
- Blood clots and deep vein thrombosis (DVT)
- Polycythemia (high red blood cell count tied to an increased risk of stroke and heart attack)
Lawsuits mount alleging testosterone therapy injuries
Across the country, dozens of testosterone lawsuits have been filed against manufacturers such as AbbVie Inc., Pfizer and Auxilium Pharmaceuticals, contending that plaintiffs were not adequately warned about the dangers of Low T supplements. The complaints allege a number of debilitating and potentially fatal side effects from using the gels, with victims suffering from heart attacks, deep vein thrombosis, strokes, TIAs and pulmonary embolism. Several wrongful death suits have also been brought by family members of those who died after using testosterone therapy. In an effort to streamline the escalating numbers of claims containing similar allegations and factual issues, federal suits were centralized in the U.S. District Court for the Northern District of Illinois, before Judge Matthew Kennelly. The Testosterone Replacement Therapy Products Liability Litigation, or MDL 2545, began with less than 50 Androgel claims and has now amassed over 1,000 cases regarding injuries allegedly sustained from various Low T drugs. Legal counsel for plaintiffs predicts that litigation will continue to expand as more studies point to testosterone and cardiovascular risks. The majority of2015 will be focused on general and case-specific discovery processes, and the first bellwether trials, which are 6 Androgel cases, are slated to go before a jury in October of 2016. Claimants are demanding compensation for all related medical expenses, lost income, reduced earning capacity, and pain and suffering based on accusations of failure to warn, fraud, negligence and unjust enrichment. Resources:
- WebMD, Low Testosterone Therapy: Risks and Benefits http://www.webmd.com/men/features/low-testosterone-therapy-risks-benefits
- Androgel.com, Diagnosing Low Testosterone http://www.androgel.com/diagnosing-low-testosterone
- FDA, Evaluating risk of stroke, heart attack and death with FDA-approved testosterone products http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm
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