FDA Calls Committee Meeting to Assess Dangers of Testosterone
December 12, 2014
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The United States Food and Drug Administration (FDA) announced that it will convene a joint meeting to assess the cardiovascular risk associated with testosterone replacement therapy. The meeting will be between the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The FDA convenes advisory committee meetings in order to gather expert advice on complex scientific, technical, and policy issues. They also provide a forum for discussing controversial issues concerning drugs, devices, and consumer products. With the recommendations of the advisory committee in mind, the FDA will often take formal action in improving the safety of the products at issue.

According to the FDA, the purpose of the upcoming advisory committee meeting is to “discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.”  The meeting will take place on September 17, 2014 in Hyattsville, Maryland.

On January 31, 2014, the FDA issued a warning on the potential cardiovascular risks associated with testosterone replacement products. The FDA announced that it was investigating the risks for men taking the drugs, including:

  • stroke;
  • blood clots;
  • heart attack; and
  • death


In June 2014, the FDA required testosterone replacement manufacturers to include a general warning in the product label about the risk of blood clots in the veins. The upcoming advisory committee meeting is a continuation of the FDA’s efforts to assess the dangers of testosterone replacement products and keep consumers fully informed of the associated risks.

The FDA’s evaluation of the dangers of testosterone replacement products comes on the heels of hundreds of lawsuits nationwide that have been filed against the manufacturers of these products, claiming that the products are unreasonably dangerous and defective, causing cardiovascular injuries, stroke, blood clots, and/or death in men.  These lawsuits are supported by a number of scientific studies linking testosterone replacement with a heightened risk of complications.  The testosterone replacement products at issue include brands such as AndroGel, Axiron, Androderm, and Testim, among others.  These products can come in the form of topical gels, transdermal patches, buccal systems (applied to the upper gum or inner cheek), and injections.

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The attorneys at Ashcraft & Gerel are investigating potential lawsuits against the manufactures of these products on behalf of men who have experienced heart attack, stroke, blood clots, or death after using a testosterone replacement product.  If you or someone you know has suffered an injury after using a testosterone replacement product, please contact us online today or call us (866) 709-0505 for a free and confidential consultation with an attorney.