Testosterone Side Effects Get a Rise Out of Consumer Advocate

Chicago, ILThe dramatic rise in popularity of testosterone-boosting products has not only resulted in record sales for the manufacturers of such products as AndroGel, Androderm, Axirom and Bio-T-Gel (among others), the phenomenon of “Low-T” will soon be reverberating through the courts. Plaintiffs having brought many a testosterone lawsuit allege they have suffered health issues from their use of the products. At the same time, the nation’s health regulator is investigating adverse reactions, and a respected consumer advocacy group wants the products banned altogether.

Men lose testosterone naturally as they age - part of the reason for sagging energy levels and weight gain that is a common occurrence in the middle years. Testosterone therapy was originally developed and approved to treat men with serious and debilitating testosterone deficiencies. However, the class has found a whole new market for men who otherwise would not be candidates, but seek to restore their energy, sex drive and muscle mass more out of vanity perhaps, than need. It's evident by the number of Low-T testing centers that have cropped up in places like Houston and Dallas, Texas. And the testosterone manufacturers are happy to provide the drug to this expanded group of patients.

However, there are testosterone side effects that can include stroke and other cardiovascular events.

Even testosterone death.

Plaintiffs in many a testosterone lawsuit claim that the manufacturers downplayed the risks associated with testosterone therapy. One such lawsuit was brought earlier this year against Androderm manufacturer Actavis Inc. by plaintiffs Roy H. Smyer and Sabrina M. Smyer (Case No. BC537755, in the Superior Court of California, County of Los Angeles). According to court documents, Smyer suffered from a pulmonary embolism shortly after being prescribed Androderm for testosterone replacement therapy. The embolism required a prolonged stay in the hospital.

Another round of lawsuits was filed in early February, and just days after the US Food and Drug Administration (FDA) announced that it had “Low-T” under its microscope.

The cases are Aurecchia v. AbbVie Inc. et al., case number 1:14-cv-00772; Benn v. AbbVie Inc. et al., case number 1:14-cv-00774; Gallagher v. AbbVie Inc. et al., case number 1:14-cv-00776; Marino v. AbbVie Inc. et al., case number 1:14-cv-00777; and Myers v. AbbVie Inc. et al., case number 1:14-cv-00780, all in the US District Court for the Northern District of Illinois.

According to court records, Abbott Laboratories had been marketing AndroGel for three years when it spun off AbbVie in January of last year as an umbrella for its proprietary pharmaceutical business. AndroGel now falls under the AbbVie banner. The plaintiffs seek punitive and other damages, and bring claims for negligence, failure to warn, breach of implied warranty and express warranty, and fraud and negligent misrepresentation.

The FDA got involved following the recent publication of studies that raised red flags. One recent study published in JAMA found a 30 percent increased risk for heart attack and stroke. Another study, published in late January of this year in PLOS ONE, found that risk for testosterone heart attack doubled in men above 65 years of age, in association with testosterone replacement therapy.

Meanwhile, the advocacy group Public Citizen has petitioned the FDA to add a black box warning to all testosterone therapy medication, warning about the increased risk for heart attack, testosterone stroke and other cardiovascular events.

“The urgency for this action is highlighted by the massive prescribing of testosterone-containing products, with more than 400,000 prescriptions filled in the US in December 2013 alone and more than 5 million filled during all of 2013,” Public Citizen said in a statement.

“Despite increasing evidence of significant cardiovascular risk from an analysis of 27 randomized clinical trials and, most recently, from a large observational study involving 45 times more testosterone-exposed men than the largest previous study, warnings of testosterone-induced cardiovascular risk are dangerously absent from the current FDA-approved labeling for all of these products.” Public Citizen cites a number of observations to support its concern, including a placebo-controlled trial that was stopped before completion because of a “significant excess of cardiovascular events in older men randomized to get testosterone instead of a placebo.”

Public Citizen characterized the FDA as being “reckless” for approving testosterone replacement products in the first place. “Unless the FDA immediately begins to provide adequately strong black box warnings about the risks of heart attacks and other cardiovascular diseases, the continuing toll of heart attacks in people who are not even candidates for testosterone will continue.”