Androgel Lawsuit Axiron Lawsuit Low Testosterone Drug Blood Clot Side Effects
Androgel Side Effects Axiron Lawsuit Filings Continue To Rise, Public Citizens Seeks Testosterone Black Box Warning
Consumer group Public Citizen has sought black box warnings on Androgel , Axiron , Bio-T Gel , Striant , Testim , Fortesta and other testosterone supplements / drugs following reports of blood clot and heart attack and other side effects in users taking these Low-T ( Low Testosterone ) drugs. In a petition sent to the FDA on February 25, the group has highlighted the findings of multiple research studies reporting that stroke, heart attack, and possibly death maybe caused by these products to press its demand for the strongest possible label warning on testosterone supplements and low T drugs.
The call by Public Citizens against Low T treatment products such as Androgel and Axiron came amid the backdrop of a number of testosterone drug / gel 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 Androgel 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 therapy treatment lawsuit filed in an Illinois federal court side effects lawsuit, Gibby started using Androgel following advertisements by the manufacturer promoting and marketing 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 just several 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.
Axiron and other Low T drugs and gels list similar side effcets at the root of lawsuits filed by Do I Have A Lawsuit Affiliated Attorneys.
More Axiron and 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 Axiron and Androgel Testosterone Treatment Risks
In September 2013, Chicago Tribune Business published results of 27 independent research studies linking testosterone supplements such as Androgel and Axiron 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.
Axiron is a drug made by Eli Lilly and Company (LLY) -NYSE
Androgel is a drug made by AbbVie Inc. (ABBV) -NYSE and former Testim partners Auxilium (AUXL) GlaxoSmithKline plc (GSK) -NYSE
Other Low Testosterone Drug Side Effects Lawsuits
Delatestryl by Indevus Pharmaceuticals
AndroDerm by Actavis
Axiron by Eli Lilly and Company
Bio-T-Gel by Teva Pharmaceuticals
Striant by Columbia Laboratories
Testim by Auxilium Pharmaceuticals
Depo-Testosterone by Pharmacia & Upjohn Company
Testopel by Auxilium Pharmaceuticals
Fortesta by Endo Pharmaceuticals
Have you or a loved one taken Androgel , Axiron or other Low T Drugs and Gels? Do I Have A Lawsuit
Note on From FDA
Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events
AUDIENCE: Cardiology, Urology, Family Practice
ISSUE: 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. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete.
BACKGROUND: Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.
RECOMMENDATION: At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: