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Man Suffers Heart Attack After Taking Testosterone Drug Testim; Alleges Lawsuit

Filed March 21st, 2014 Laurie

A Vineland, New Jersey couple is suing Auxilium Pharmaceuticals Inc. and Philadelphia’s GlaxoSmithKline for an injury the husband alleges was caused by the companies’ testosterone replacement drug, Testim.

According to the complaint filed in Philadelphia’s Common Pleas Court on behalf of Edwin and Eileen Rios, Edwin Rios began using Testim testosterone gel because he believed he was suffering from “Low T,” a condition concocted by hormone replacement manufacturers to draw in men who are experiencing the normal symptoms of aging. Symptoms generally consist of low sex drive, irritability, fatigue, and loss of muscle mass, PennRecord.com reported.

The complaint alleges that Auxilium and GlaxoSmithKline knew that a decrease in testosterone levels in aging men is normal and that unnaturally restoring testosterone puts men at risk for heart attack, stroke, and other cardiovascular events, according to PennRecord.com

Rios, a Type II diabetic, began using Testim in May 2012 and suffered a heart attack last spring, which he blames on Testim. The 67-year-old has no history of cardiovascular problems, PennRecord.com reported.

In the lawsuit, Rios accuses the drug makers of knowing the risks associated with Testim and failing to adequately warn the public. The complaint calls the drug “defective in its condition and unreasonably dangerous with respect to its design, warnings, instructions, and/or indications for use,” according to PennRecord.com.

Additionally, the complaint accuses the drug manufacturers of orchestrating a “national awareness campaign and multi-platform media initiative and program to purportedly educate male consumers about the signs and symptoms of ‘Low T,’ and to introduce a ‘cure’ for ‘Low T’ in the form of, among other prescription testosterone-containing preparations, Testim,” PennRecord.com reported.

“Defendants repeatedly and knowingly represented, through deeds, action, and words, including an aggressive and pervasive direct-to-consumer advertising campaign, that low testosterone levels and ‘Low T’ were pathologic entities requiring treatment,” the complaint obtained by PennRecord.com reads.

Edwin Rios is suing for pain and suffering, loss of life’s pleasures, physical debility, mental anguish, fear and fright, embarrassment and humiliation, economic loss, requirement for medical monitoring, and past, present and future medical expenses, the complaint states. Edwin’s wife, Eileen Rios, is suing for the loss of marital consortium. The couple seeks unspecified compensatory damages along with interest, costs and delay damages, according to PennRecord.com.

The FDA has only approved testosterone containing drugs for men who produce low levels of the hormone due to underlying medical conditions, not simply aging. The drugs are typically sold as gels, patches, and injections. A study published in JAMA in November 2013 found an increased risk of death, heart attack, and stroke associated with the use of testosterone.

In July 2010, a clinical study of Testim in older, frail men being conducted by Boston University was halted after only six months because some of the men in the study developed heart problems. The study was designed to determine if men over 65 with mobility problems could benefit from the gel. Twenty-three out of 106 men receiving Testim experienced fainting, chest pain, or heart attack. One man died of a suspected heart attack. Testim was approved by the FDA in 2002.

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