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Testosterone Risks: FDA Requires New Warning Label

testosterone therapy

The FDA now requires a warning label to inform the public of a possible increase of heart attack and stroke in prescription testosterone users.

New FDA Warning Label

On March 3, 2015, the Food and Drug Administration (FDA) released a Drug Safety Communication requiring manufacturers of all approved prescription testosterone products to change their labeling to clarify the approved uses of these medications. The FDA now requires manufacturers to add information to the labeling of the testosterone products about a possible increased risk of heart attacks and strokes in patients taking testosterone. In addition, the FDA cautions that healthcare professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.

Testosterone: What it IS and is NOT FDA Approved For

The FDA has approved prescription testosterone products only for men who have certain medical conditions, such as:

  • the failure of the testicles to produce testosterone because of genetic problems; and
  • problems with brain structures that control the production of testosterone by the testicles

However, as the FDA clarified in its most recent announcement, the benefits and safety of the prescription testosterone products have not been established for the treatment of low testosterone levels due to aging, and none of the FDA-approved testosterone products are approved for use in men for this reason.

Investigating Testosterone Safety

On January 31, 2014, the FDA announced it was investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products. In this announcement, the FDA stated that they “have been monitoring this risk and decided to reassess the safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.”

Following the announcement in January 2014, the FDA issued a public health warning on June 19, 2014 requiring the product’s manufacturers to include a general warning in the product labeling about the risk of blood clots in veins. The FDA issued this warning following “post-market reports of venous blood clots” in those taking the products. You can read more about this warning here.

FDA: Testosterone Products May Lead to Increased Heart Problems

This new Safety Communication comes after an FDA Advisory Committee meeting during which the FDA reviewed expert input and available evidence from studies regarding the health risks of prescription testosterone products. Based upon its review of these materials, the FDA concluded that there is a possible increased cardiovascular risk associated with testosterone use. The FDA also cautioned that all healthcare professionals should make patients aware of the possible risks when deciding whether to start or continue a patient on testosterone therapy. In addition, manufacturers of approved testosterone products are required “to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products.”

Lawsuits against testosterone replacement manufacturers have been consolidated in a multidistrict litigation proceeding in the U.S. District Court for the Northern District of Illinois. These lawsuits allege that the testosterone products are defective and failed to warn against the risks of the products. The specific testosterone therapy products at issue include:

  • AndroGel
  • Axiron
  • Androderm and;
  • Testim

Know Your Rights

Our lawyers at Ashcraft & Gerel are currently investigating claims against the manufacturers of testosterone products. If you or someone you love has been harmed by the non-FDA approved use of these testosterone products, you may be entitled to compensation. Please contact us today online or call us at 800-829-7037. All consultations are 100% free and confidential.