Androgel Class Action Lawsuit Low Testosterone Side Effects
Androgel Lawsuits Continue To Rise, Public Citizens Seeks TestosteroneBlack Box Warning
Consumer group Public Citizens has sought black box warnings on Androgel and other testosterone supplements following reports of heart attack in users taking these Low-T drugs. In a petition sent to the FDA on February 25, the group has highlighted findings of a number of research studies reporting about strokes, heart attack, and death caused by these products to press its demand for the strongest possible label warning on testosterone supplements.
The call by Public Citizens came in the backdrop of a number of testosterone therapy lawsuits filed in various federal courts across the United States in recent months. One of the latest Androgel lawsuits filed on February 10, 2014, by a North Carolina man claims that he experienced blood clot-related disorders, including deep vein thrombosis and pulmonary embolism, after using the testosterone gel. Roger Gibby, the plaintiff, seeks product liability against AbbVie, a unit of Abbot Laboratories, for its failure to highlight potential side effects of Androgel, resulting in adverse cardiovascular events.
According to the testosterone treatment lawsuit filed in an Illinois federal court, Gibby started using Androgel following advertisements by the manufacturer highlighting the supplement as an effective solution for older men looking for a solution to overcome loss of sex drive, falling strength, and depression. However, he experienced blood clots impacting his legs and lungs after using the Low-T supplement for a few weeks.
“AndroGel causes the hematocrit level to increase, thereby thickening the blood and this effect, if not monitored and controlled properly, can lead to life-threatening cardiac events, strokes and thrombolytic events (including pulmonary embolism, deep vein thrombosis and other blood clots),” read documents submitted by Gibby’s lawyer in the court.
More Androgel Lawsuits Link Testosterone Therapy to Heart Attacks
Gibby’s Androgel lawsuit was preceded by four similar litigations filed in a Chicago court on February 4, 2014. The plaintiffs, Kenneth Aurecchia of Rhode Island, Steve Marino of Missouri, Steven Myers of Texas, and Michael Gallagher of Virginia, experienced Androgel cardiovascular side effects after using the supplement to improve testosterone levels. Two of them were hospitalized following heart attacks while one had a stroke.
The fourth one suffered congestive heart failure attributed to heart attack. None of them had a history of heart disorders and were inspired to use the testosterone supplement after watching promotional ads by the manufacturer targeting older people, who do not require such medications to treat decline in testosterone level along with natural aging.
Androgel lawsuits have also highlighted wrong marketing practices by manufacturers that focus on convincing people to use these supplements when general symptoms, such as “falling asleep after dinner or feeling “sad or grumpy,” are apparent. According to plaintiffs, these “disease mongering” Androgel promos by AbbVie induce many men to go for the Low-T supplement despite no medical requirement.
Research Studies Indicate Testosterone Treatment Risks
In September 2013, Chicago Tribune Business published results of 27 independent research studies linking testosterone supplements to heart problems. The report warned of a two-fold enhanced heart attack risk in people using testosterone medications.
Findings of a research published in the Journal of the American Medical Association in November 2013 claimed that Androgel and similar testosterone treatment medications could raise the risk of heart problems by 29 percent. Based on a sample study of over 1,200 men treated at VA Eastern Colorado Health Care center, the study found that incidences of heart attack, stroke, and death due to cardiovascular disorders are most likely to be reported among the older people using testosterone medications.
Four months before this report, the journal published an article entitled “Low ‘T’: How to Sell Disease,” highlighting the abuse of testosterone supplements. It blamed the unethical marketing practices adopted by manufacturers to convince older people into making rampant use of these medications for lifestyle purposes.
The Wall Street Journal published a report in 2013 claiming that the National Institutes of Health stopped a testosterone treatment research in 2009 after reports of high incidences of heart attack among volunteers.
The New York Times made a startling revelation on February 3, 2014, that accused testosterone supplement producers of hiding information on cardiovascular complications linked to their products. It published findings by Boston-based researchers, who had warned of a five-time increased risk of cardiovascular disorders caused by testosterone medications a decade ago. However, the results of the clinical trials were never made public.
On January 29, 2014, PLOSOne medical journal reported the results of a comprehensive study on testosterone treatment side effects. Led by California university scholars, the research looked into the medical history of over 55,000 men to conclude that healthy people undergoing testosterone therapy face a 36 percent higher risk of heart attack. According to the study, the risk substantially goes up with age.
FDA Warning and Call For Safety Review
The FDA announced a safety assessment of Androgel and similar Low-T supplements on January 31, 2014, after research reports warned about the association between heart disorders and testosterone treatment. “FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products; we have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy,” the press release read.
The federal regulator has received at least 12 reports of death, 18 cases of strokes, and 42 instances of heart attacks linked to Androgel. There are also reports of incidences where testosterone gel was blamed for creating clots that obstructed blood flow to the lungs 44 times.