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Shezad Malik MD JD
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Testosterone California Testim Stroke Lawsuit

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A 58-year-old California man who suffered injuries after using the testosterone therapy Testim has sued manufacturer Auxilium Pharmaceuticals Inc., claiming it coordinated a massive ad campaign to aggressively promote the need for its product while failing to warn users of life-threatening side effects.

In a Feb. 26 lawsuit filed in U.S. District Court for the Central District of California, plaintiff Joseph Myers alleges that after taking multiple does of Testim in 2012, he suffered a stroke, which his physicians later informed him was likely caused by the drug.

Watchdog Public Citizen Petition

As the risks of off label Testosterone replacement therapy (TRT) is being heavily reported, the consumer group Public Citizen is urging the  federal drug regulators to require a new “black box” warning. The prominent watchdog group has petitioned the FDA about the potential heart attack risks of TRT, with the use of AndroGel, Testim, Axiron and other Testosterone products.

Public Citizen filed a petition with the FDA on February 25, and requested the strongest warning label possible for the testosterone treatments. Several recent medical studies have highlighted the side effects of TRT, which may increase the risk of heart attacks, strokes, blood clots and death.

FDA Launches Investigation Into Testosterone Safety

On January 31, the FDA announced an investigation into the heart safety of TRT. According to a study published November 2013, in the Journal of the American Medical Association (JAMA), testosterone products were linked to increased risks of heart attacks, strokes and death among older men with certain pre-existing heart conditions.

Most recently, in a study published the medical journal PLoSOne in January 2014, TRT may double the risk of heart attack for young men with heart disease as well as for men age 65 and older who had no prior heart problems. The data found that for every 1,000 men over the age of 65 who uses AndroGel or another TRT product, 11.52 may suffer a heart attack. That compares to only 5.27 men per 1,000 who do not use testosterone.

Blockbuster: Millions of Testosterone Prescriptions

Testosterone therapy has been heavily marketed, as direct-to-consumer marketing has urged men to seek prescription treatment for low testosterone levels, or “low T”. These slick, aggressive male orientated advertisements, ask the intended audience questions, if they are experiencing fatigue, decreased sexual libido, mood changes and other non-specific symptoms that are associated with the normal male aging process.

The commercials explains that the man may have a condition called “low T” which is short for low Testosterone.

Big Pharma On the Move

The largest Big Pharma companies that make and market Low T medical products are:

Abbvie, Inc. (a wholly owned subsidiary of Abbott Labs), AndroGel testosterone gel.

Elli Lilly and Company, testosterone underarm gel Axiron.

Actavis, Inc., Androderm

Endo Pharmaceuticals, Fortesta Testosterone Gel

Auxilium Pharmaceuticals, Inc., Testim Testosterone Gel

BioSante/Teva, Bio-T-Gel