Testosterone Lawsuit: FDA Requires Low T Drug Producers To Conduct Clinical Trials

FDA Requires Clinical Trials For Low TThe 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.

By | 2016-10-25T16:45:18+00:00 August 21st, 2015|Prescription Drugs|2 Comments

About the Author:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including products liability, nursing home abuse and personal injury.

Got a question for Laurence? Call him directly on: 917-633-4808

2 Comments

  1. Reta Griffith August 22, 2015 at 1:51 pm - Reply

    We have legal representation. In 2008 my husband placed a request with the VAMC to verify his need for a service upgrade to increase his VA pension. His request was based on a PTSD claim which was eventually approved. This inquire required a very indepth medical scrutny of his physical and mental health. The VAMC had to make certain his conditon was service connected. He was given numerous medical tests over the next several years with emphasis placed on lab testing to rule out substance abuse, to determine his general, over all health condition as we had a claim in for Agent Orange Exposure which was ruled out due to NEVER having been exposed – he was in the NAVY on a ship which was not listed as being a risk for AO. Considerable care was taken to reveal any condition which was indicative to AO exposure at our request and our Private Care Physician. When no symtoms or maladys were discovered, my husband was placed on Low T to ease what the VAMC doctors felt was the culprit behind the depressive mood he was experiencing. This close medical data collected during the introduction of this arificail hormeone maps the rapid decline in my husband’s cardic health as well as a troubling conditon in his blood’s thick clotting ability – he was rapidly becoming prone to the formation of a blood clot. Shortly after being placed on Low T my 58-yr-old husband had a major heart attack – there is no family history of heart disease, no other culprit to exaplin this near death experience other than the well documented introduction to Low T replacement – I sincerely hope this encourages other men to file a claim – we have the smoking gun, a well charted map leading right back to his being prescribed Androgel.

    • Laurence August 24, 2015 at 9:58 am - Reply

      Reta, Thank you for sharing.

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