Have You Been Injured? We're Ready to Fight for You.

FDA To Convene Testosterone Advisory Panel

Published on Sep 26, 2014 at 8:26 am in Testosterone Therapy.

This week, the U.S. Food & Drug Administration (FDA) will convene an expert panel to discuss the widespread use of testosterone replacement therapy and its risks of serious medical side effects.

The panel follows up the FDA’s safety announcement, issued in January, noting that it was looking into studies that had shown a possible risk of heart attack, stroke and death in men using testosterone treatments

The panel will be a joint meeting of two outside advisory committees: the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The two primary agenda topics, set for September 17 in Maryland, are:

  1. The appropriate indicated population for testosterone replacement therapy (TRT), and
  2. The potential for adverse cardiovascular outcomes associated with use of TRT.

Prior to the meeting, the FDA released a background brief. It stated that 2.3 million men were prescribed testosterone in 2013, which is an increase of 77 percent over 2010. This rise is attributed to heavy direct-to-consumer advertising “emphasizing the benefits of TRT related to quality-of-life, such as vitality and strength, and non-branded disease awareness campaigns of ‘low T’ have targeted a broad population of men.” Data from commercial health insurance claims show the largest group of patients prescribed testosterone is men from 40 to 60 years old.

The FDA emphasized that “more than 20 percent of patients who received a prescription did not have any record that their testosterone levels were measured.” It said this is a problem for the following reason:

“This is particularly concerning because the diagnosis of hypogonadism requires documented evidence of low or absent serum testosterone concentrations and the appropriate TRT dose cannot be determined without following serum testosterone concentrations on therapy.”

While the drug was approved for use for men with low testosterone along with associated medical conditions, the concern is the explosion in marketing of the drug to men who are simply aging. The debate now is over whether the drug is appropriate for this population and whether it poses unnecessary risks.

The FDA backgrounder concluded that there wasn’t much evidence to show that testosterone treatments provided any benefits for men who used the drugs to alleviate typical aging symptoms of fatigue, and low libido.

According to court records, since the FDA’s safety announcement in January, more than 170 lawsuits have been filed in the Northern District of Illinois against the manufacturers of testosterone treatments, including AndroGel, AndroDerm and Testim. The manufacturers include Abbvie, Eli Lilly, Endo Pharmaceuticals and Upshur-Smith Laboratories.

The lawsuits generally allege that the plaintiffs were injured by the use of the testosterone therapy – suffering heart attacks, strokes, blood clots, or other cardiovascular events– and that the manufacturers did not adequately warn patients about the risks.

Meet Your Team

Tad Thomas - Trial Lawyer

Tad Thomas

Managing Partner

Tad Thomas has dedicated his practice to representing plaintiffs in various types of civil litigation, including personal injury, business litigation, class actions, and multi-district litigation.

After graduating with his law degree in 2000 from Salmon P. Chase College of Law at Northern Kentucky University, Mr. Thomas immediately opened his own private practice and began representing injury victims.

In 2011, Thomas Law Offices was established in Louisville, Kentucky. Over the past decade, Mr. Thomas has expanded his firm and now has offices in three additional locations: Cincinnati, Ohio, Columbia, Missouri, and Chicago, Illinois. He is also a frequent lecturer on topics like trial skills and ethics and technology.

Free Case Evaluation

At Thomas Law Offices, our personal injury attorneys recognize that our potential clients are likely going through some of the most difficult times of their lives. We don't want you to have to worry about paying out-of-pocket for legal advice when you're just starting to learn your legal rights and options. That's why we provide free case evaluations. We'll offer our expert advice about your potential case and walk you through how we can help you.

Call us or fill out the form below to tell us about your potential case and a personal injury lawyer will get back to you as quickly as possible.

Legal & Firm News

Multi-Vehicle Accidents: Who Pays for Chain Reaction Crashes?

You’re driving down the road on your way to work in heavy traffic. Everything seems standard for your morning commute until you’re sideswiped by a passing vehicle and subsequently rear-ended by the car behind you when you brake. Emergency responders arrive at the scene, and you’re treated for your injuries and told to follow up […]

Read More

5 Questions to Ask During a Free Case Consultation

If you’ve been injured in an accident and are looking to pursue compensation from the at-fault party, you may not know where to turn. Fortunately, personal injury lawyers can help accident victims file a strong claim that proves a monetary award is owed.

Read More

How to Stay Safe Around Pools This Summer

As we’re now just past the Fourth of July holiday weekend, summer is in full swing. With the 2021 heatwave affecting most of the continental U.S., pool owners all around the country are taking full advantage of their backyard oases to beat the heat. Those without pools looking to take a dip in the water […]

Read More