The purported benefits of testosterone therapy are enticing for thousands of men who suffer the effects of “low T.” Also known as androgen replacement therapy, testosterone supplements have been touted as the quickest way to help aging men improve sex drive, increase muscle mass and boost energy. But are products like Androgel and Axiron, which have been promoted as revolutionary anti-aging formulas, without latent risks?
According to a study published by PLOS One, testosterone therapy doubled the risk of heart attack in men over the age of 65 and nearly tripled the risk in younger patients with a history of heart disease. Spurred by a handful of clinical trials that demonstrated adverse cardiovascular outcomes with testosterone therapy, the FDA announced it would be “investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products,” in January 2014.
Men who suffered injury after taking Androgel or other testosterone treatments may be entitled to monetary damages by filing a testosterone therapy lawsuit. Manufacturer Abbot Laboratories is facing at least four product liability claims involving Andgrogel heart problems, in which plaintiffs argue the company deceived consumers with slick ad campaigns that glossed over risks and potential side effects.
“Low T” overview
Low testosterone, also known as hypogonadism, affects nearly 40 percent of men over the age of 45. Testosterone levels dip dramatically as men age, leaving 30 percent of those 70 and older with “low T.” Unfortunately, low levels of testosterone are often associated with embarrassing symptoms such as erectile dysfunction and a non-existent libido. Testosterone therapy comes in many forms, including injections, gels, long-acting pellets, oral inserts and patches — though gel is used by more than 70 percent of patients.
Disclaimers on the Androgel (1%) website state that typical testosterone side effects of the product include acne, increased cholesterol levels and abnormal liver function. The manufacturer cautions that more serious side effects such as low sperm count, worsening symptoms of an enlarged prostate, swelling of ankles, enlarged breasts, sleep apnea, and blood clots in the legs should also be noted.
However, a much more dangerous risk with testosterone therapy – especially among men with a history of cardiovascular problems – is the heightened threat of heart attacks.
Diagnosing and treating low testosterone
In addition to primary care physicians, numerous clinics provide blood tests for testosterone levels and offer a number of supplements. A man is usually diagnosed with low testosterone when levels have fallen below 300 ng/dL (between 300 and 1000 ng/dL is considered normal).
Those who suffer from low testosterone may complain of mood swings, depression, irritability and sexual dysfunction. But symptoms can range widely, and also affect one’s health.
Physical changes attributed to low testosterone may include:
- Increase in body fat, decrease in muscle mass
- Decrease in hemoglobin with mild anemia
- Decrease in body hair
- Adverse changes in cholesterol levels
The following testosterone therapy replacements are available to the public:
Research on testosterone therapy and heart risks
For males who suffer dramatically low T levels, products like Androgel may be a blessing. But research published by the Journal of the American Medical Association raises questions about the safety of testosterone therapy.
The results found that men with prior heart troubles who took testosterone supplements had a nearly 30 percent increased risk of heart attack, stroke and death. The research was conducted at University of Texas at Southwestern Medical Center in Dallas, where the records of more than 8,700 men over the age of 60 were reviewed. Of the 1,223 patients taking testosterone treatments, 23 suffered heart attacks, 33 had strokes and 67 died within an 18 month period.
At the Boston University School of Medicine, a previous study on testosterone therapy revealed that men who took supplements were five times more likely to suffer congestive heart failure compared to patients who took a placebo.
In light of growing safety concerns and the recent FDA investigation into the dangers of testosterone replacement products, attorneys are currently evaluating claims made by men under the age of 70 who took supplements for their low T and suffered one or more of the following:
- Heart Attack
- Portal Vein Thrombosis
- Pulmonary embolism
Legal recourse available to victims
While the FDA only approved Androgel and similar testosterone products for the treatment of hypogonadism, thousands of men may be using the supplements without a definitive blood work-up. In light of mounting evidence of heart attack and blood clot risks, more men are seeking help from a testosterone injury lawyer.
A personal injury /product liability claim may be warranted in cases where patients suffered harm through the negligence or misrepresentations of a drug manufacturer. Causes of action often include failure to warn, manufacturing defect, and breach of implied and express warranties.
Compensation awarded in testosterone therapy lawsuits would account for damages such as:
- Lost income
- Loss of future earnings
- Related medical expenses
- Pain and suffering
- Emotional distress
Status of Androgel lawsuits
As of early 2014, at least four men are seeking damages in Androgel lawsuits, brought in the U.S. District Court for the Northern District of Illinois. All of the plaintiffs suffered cardiovascular injuries, including stroke, heart failure and heart attack after using the product, and each claims Androgel is the culprit since none of them had a prior history of heart problems.
The plaintiffs allege that Abbott and its spinoff AbbVie Inc. conducted a misleading advertising campaign to convince millions of men that they suffered from low testosterone levels. This alleged “disease awareness” campaign ultimately netted the companies some $1.4 billion in sales. Many legal experts speculate that complaints like these are just the beginning, as patient awareness on testosterone therapy side effects increases.
- USA Today, Testosterone therapy doubles heart risk in older men, http://www.usatoday.com/story/news/nation/2014/01/29/testosterone-heart-risks/4967795/
- US News, FDA Will Review Safety of Testosterone Therapy, http://health.usnews.com/health-news/articles/2014/02/03/fda-will-review-safety-of-testosterone-therapy
- WebMD, Erectile Dysfunction: Testosterone Replacement Therapy, http://www.webmd.com/erectile-dysfunction/guide/testosterone-replacement-therapy
- FDA, FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products, http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm
- Medicine.net, testosterone gel (Androgel), http://www.medicinenet.com/testosterone_gel-topical/article.htm