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On January 31, 2014, the FDA ordered for a safety review of Low-T supplements following reports of blood clot, heart attack, stroke, and cardiovascular deaths caused by testosterone replacement treatment. The announcement came a day after PLOSOne medical journal published a study that warned of a two-fold rise in the heart attack risk following use of testosterone supplements. Androgel Low-T medication has been reported to the FDA for at least 44 reports of blood clots, 42 reports of heart attacks, 18 reports of strokes and 12 deaths.
“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 feral regulator announced on January 31st.
Testosterone Replacement Therapy Doubles Heart Attack Risk
The FDA order for Low-T supplement safety review came a day after PLOSOne medical journal highlighted a two-time increased risk of adverse cardiovascular events in people using testosterone replacement therapy. Published on January 29, 2014, the research based on joint findings by the Maryland-based National Cancer Institute and California University scholars from Los Angeles examined about 55,000 men.
According to the study, use of Androgel and similar testosterone replacement medication by healthy men raise the risk of heart attack by 36 percent, which increases with age. Those with preexisting cardiovascular problems or above 65 years face at least a two-time increased risk of strokes and heart attack.
An earlier study reported by the Journal of the American Medical Association in 2013 had warned of 29 percent risk of heart attack in men subject to testosterone replacement treatment.
NY Times Accuses Testosterone Supplement Manufacturers of Hiding Heart Attack Report
In February 2013, a report in the New York Times accused testosterone replacement medication producers of withholding research information linking their supplements to heart attack risk. According to it, decade-old findings by a group of Boston scholars highlighting five-time rise in the risk of heart disorders was kept away from the public domain until 2010. Though the report highlighted potential heart attack side effects of Low-T treatment, consumers were never told about it for a decade.
In 2013, the Wall Street Journal disclosed that a research conducted under the aegis of the National Institute of Health was terminated midway in 2009 after researchers found high number of adverse cardiovascular events in volunteers. A July 2013 report in the Journal of the American Medical Association blamed aggressive marketing by Low-T supplement manufacturers for abuse of testosterone replacement therapy. Entitled “Low ‘T’: How to Sell Disease,” the report highlighted how supplement producers had encouraged using their products without medical testing and prescription.
Public Citizen Seeks Black Box Warning on Androgel, Other Low-T Medications
Consumer watchdog Public Citizen has demanded FDA “black box” warning on AndroGel, Testim, and similar testosterone patches, gels, and supplements for potential heart disorder risks. The demand assumes significance in the light of research reports and mounting testosterone treatment lawsuits highlighting death, strokes, and heart attacks because of Low-T medication side effects.
Over 30 Androgel lawsuits filed in Illinois have been centralized for pretrial proceedings at the court of Judge Matthew F. Kennelly. Testosterone treatment lawsuits continue to be filed nationwide seeking product liability from manufacturers for strokes, heart attacks, and other injuries caused by Low-T supplement side effects.
If you or a loved one have experienced a testosterone replacement therapy injury after undergoing low testosterone therapy, please contact our team of lawyers today for a free case evaluation at:
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