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FDA Approves New Testosterone Therapy Drug as Side Effect Lawsuits Mount

Filed March 10th, 2014 Laurie

After three previous rejections by the U.S. Food and Drug Administration (FDA), a testosterone therapy called Aveed has finally gained the agency’s approval.

The last time Aveed was rejected was last May, when the FDA expressed concerns about castor oil in the formulation causing blockages in blood vessels in the lungs, and of complications caused by post-injection reactions. Endo International Plc said it needed to devise a better plan to manage the risks associated with Aveed, according to Reuters.com.

Last month, the consumer advocacy group Public Citizen urged the FDA to delay a decision on Aveed, saying testosterone therapy drugs should contain strong warnings about the risk of heart problems, Reuters.com reported.

Aveed is intended to treat hypogonadism, a condition in which the body does not make enough testosterone, which is necessary for maintaining muscle mass, bone growth, and sexual function. Men with low testosterone may suffer from depression, loss of libido, and fatigue, according to Reuters.com.

As we reported earlier last month, testosterone therapy doubles the risk of heart attack in men age 65 and older, and triples the risk of heart attack in younger men with a history of heart problems. Many men are putting their lives at risk because they are fearful of aging and losing their “edge.” Some drug companies that manufacture testosterone replacement drugs are only adding to this phobia.

Public Citizen has petitioned the FDA to place a “Black Box” warning on testosterone drugs based on mounting evidence of cardiac risks that have been appearing in studies in 2010, as well as a recent published analysis of 27 studies dating back 20 years. The group said that of the 27 studies, 14 were not industry funded.

When advertisements for the treatment of “Low T” started popping up, the market for hormone therapy exploded. Sales of testosterone gel, such as AndroGel, Androderm, Axiron, Bio-T-Gel, and Delatestryl, generated more than $2 billion in sales last year. What many men don’t realize is that Low T, according to many doctors, does not exist. They are simply experiencing natural aging, and trying to reverse or stop that can be more dangerous than letting nature take its course.

Lawsuits filed on behalf of patients who were seriously injured by one of these hormone drugs are on the rise, many of which claim that even though the FDA has only approved these therapies for men who have low testosterone due to an underlying condition, they are often prescribed to men who have normal testosterone levels, putting them at increased risk for serious health problems.

Legal experts expect many more lawsuits to be filed in the coming weeks and months.

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