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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

AndroGel manufacturer stirs up undue concern over “low-T”

Posted in Androgel, Lawsuits

As lawsuits concerning the testosterone therapy drug AndroGel have recently been filed, a great deal of information has come to light concerning the marketing of that product.

Here is an excerpt from one of the current AndroGel lawsuits:

“In 2000, when the FDA approved AndroGel, the company announced that the market was ‘four to five million American men.’ By 2003, the number increased to ‘up to 20 million men.’ However, a study published in the Journal of the American Medical Association (‘JAMA’) in August 2013 entitled ‘Trends in Androgen Prescribing in the United States, 2001-2011’ indicated that many men who get testosterone prescriptions have no evidence of hypogonadism. For example, one third of men prescribed testosterone had a diagnosis of fatigue, and one quarter of men did not even have their testosterone levels tested before they received a testosterone prescription.”

Does it really seem likely that the prevalence of hypogonadism would quadruple in three years, or does this simply look like a case of improper marketing?  It is interesting to note that when then-manufacturer of AndroGel, Unimed Pharmaceuticals, Inc., first sought AndroGel approval by the FDA in 1999, “hypogonadism was estimated to affect approximately ‘one million American men.’”  A twenty-fold increase in disease prevalence is staggering, and would represent an epidemic if it were real.  Thankfully, it isn’t.

However, the good news that hypogonadism isn’t so prevalent may likely be eclipsed by the prevalence of AndroGel use and the accompanying negative side effects — which include a dramatically-increased risk for heart attack and stroke.