FDA Requires Clinical Trials For Low T The Food and Drug Administration (FDA) is now requiring the manufacturers of testosterone therapy medications to conduct clinical trials on their drugs.

In an August 20th edition of the New England Journal of Medicine (NEJM), FDA officials wrote that there is still “no proof” that testosterone supplements are safe or effective.

Additionally, the perspective from the NEJM noted that the only way to prove whether or not men with low levels of testosterone benefited from these medications is through controlled clinical trials.

As a result, the FDA is now requiring manufacturers of Testosterone Replacement Therapy (TRT) supplements to perform those controlled clinical trials to test the overall safety and efficacy of the medications. More specifically, the FDA is encouraging the producers of these drugs to work together on a single clinical trial.

About Low Testosterone

As men age, their bodies naturally produce lower levels of testosterone which can lead to fatigue, a diminished sex drive and several other symptoms.

At the moment, testosterone supplements have only been FDA-approved for men with certain medical conditions that are known to cause low levels of testosterone. However, once a drug is FDA-approved, doctors can prescribe it “off-label” for other medical conditions that they believe is appropriate.

As a result, low testosterone supplements have become extremely popular in the US market over the past decade as millions of aging men have been prescribed the drugs to combat the symptoms associated with lower levels of t

During a four year period ending in 2013, the total number of men taking testosterone supplements nearly doubled from approximately 1.3 million to 2.3 million.

Many argue that aggressive marketing by the manufacturers of these “Low T” supplements played a major role in the increased amount of prescriptions in recent years.

Unfortunately, research has found an association between the use of testosterone therapy medications and a man’s risk for dangerous events including heart attack or stroke.

In fact, in March of 2015 the FDA required that the producers of all approved prescription testosterone products begin labeling their products with a warning of the potential risks.

Can I File A Lawsuit?

Men who had been prescribed low testosterone therapy treatments and experienced medical complications are now filing lawsuits against the pharmaceutical companies that manufacture the medications.

On June 6th, 2014, a Multidistrict Litigation (MDL) was formed regarding the allegedly adverse side effects of these Low T drugs. The MDL is taking place in the U.S. District Court for the Northern District of Illinois and now consists of more than 2,300 consolidated complaints against several drug manufacturers.

The first bellwether trial is scheduled to begin in October of 2016 where the pharmaceutical company AbbVie will go on trial for its drug AndroGel.

“We are doing everything we can to educate individuals and families across the country about the alleged risks of low testosterone medications,” said Laurence Banville, Esq.

Banville is a sponsor of the online resource center LowTestosteroneCase.com, which is dedicated to providing helpful information and access to legal representation for plaintiffs in the Low T litigation.

For more information about this press release or the pending litigation, contact Laurence Banville, Esq. at 888-478-9711.

About Laurence Banville

Attorney Contributor:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including negligent security cases, child sexual abuse and Dram Shop and liquor liability cases.

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