Friday, February 28, 2014

Unsafe Drug Alert: Testosterone Replacement Products


On January 31, 2014, the Food & Drug Administration ("FDA") launched an investigation into the risks of testosterone replacement therapy through the use of products including AndroGel®, AndroDerm®, Axiron®, and Testim®.  

Alarming new research suggests that millions of men may be at risk for a heart attack, stroke or premature death by taking testosterone therapy they don’t actually need and “Low T” testosterone replacement therapy lawsuits have already been filed in Federal District Court.  

Booming "Testoterone Replacement Therapy" Market 

In the past several years, testosterone replacement therapies manufacturers have aggressively marketed their product for treatment of common and natural effects of aging in men - - like normal decline in sexual drive, energy and athleticism - -  by describing these effects as a new medical condition called “Low T.”  

According to the industry, such symptoms call for treatment with testosterone replacement therapy and a prescription for one of their testosterone supplement products. 

While testosterone has been in limited clinical use since 1937 and approved by the FDA since 1953, testosterone can now be administered by patients at home, and the drug comes in at least five forms including patches, gels and injections.  

According to the FDA, prescription testosterone is only indicated for men with demonstrated low testosterone levels and an associated medical condition known as “hypogonadism.”  In recent years, "testosterone replacement treatments" use has increased radically, largely due to increased manufacturers advertising on websites www.isitlowt.com and www.low-testosterone-option.com.  

Since 2001, the number of testosterone prescriptions given to American men has tripled and in 2012 sales were estimated at $2 billion with three million prescriptions being written for the market leader AndroGel® alone.  

Testoterone Replacement Therapy Litigation 

Alarming new research suggests that millions of men may be at risk for a heart attack, stroke or premature death by taking testosterone therapy they don’t actually need.

 On January 29, 2014, the respected medical journal PLoS ONE found that prescription testosterone can double the rate of heart attacks in men 65 and older and triple the risks in younger men with a history of heart disease.  Another study published by The Journal of the American Medical Association found that men age 60 and older using testosterone drugs had a 30 percent greater risk for stroke, heart attack, and death compared to those who didn’t use testosterone replacement drugs.  

Lawsuits related to the use of testosterone replacement therapy for so-called “Low T” which seek compensation for such injuries have already been filed in Federal District Court.