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FDA Requires Heart Attack, Stroke Warning to be Added to Testosterone Supplement Labels

The FDA is requiring all manufacturers of approved prescription testosterone supplements to update their products’ labeling to include info about a potential increased risk of heart attack and stroke.

The U.S. Food & Drug Administration (FDA) is requiring all manufacturers of approved prescription testosterone supplements to update their products’ labeling to include information about a potential increased risk of heart attack and stroke. FDA warns that testosterone replacement therapy (TRT) drugs are only approved for the treatment of clinically low levels of testosterone caused by certain medical conditions, and not to treat symptoms associated with the normal aging process.

Free Testosterone Lawsuit Evaluation: If you or a loved one was injured after undergoing testosterone replacement therapy (TRT), you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the testosterone supplement and we can help.

What’s the Problem?

On March 3, 2015, FDA issued a press release announcing label changes for all approved prescription testosterone boosters. After an analysis of studies and expert input from an FDA advisory committee meeting, the agency has determined that there is a potential link between the use of testosterone and an increased risk of adverse cardiovascular side effects.

FDA has only approved testosterone replacement therapy as a treatment for men who have low testosterone levels caused by disorders of the testicles, pituitary gland or hypogonadism. However, the supplements have frequently been prescribed “off-label” to men who have low testosterone for no apparent reason other than the natural aging process. The benefits and safety of this use have not been established.

FDA Recommendation

FDA recommends that doctors only prescribe testosterone supplements to men with legitimately low levels of testosterone as confirmed by laboratory tests. Doctors are encouraged to discuss the potential benefits and risks of testosterone supplementation with patients before prescribing. Testosterone users should seek immediate medical attention if they experience symptoms of a heart attack or stroke, which may include:

  • Chest pain
  • Shortness of breath / trouble breathing
  • Weakness on 1 side of the body
  • Slurred speech

Which Products are Affected?

The following FDA-approved prescription testosterone supplements will have their labels changed to include information about the heart attack / stroke risk:

Do I Have a Testosterone Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Testosterone Lawsuits. We are handling individual litigation nationwide and currently accepting new testosterone side effects cases in all 50 states.

Free Testosterone Lawsuit Evaluation: If you or a loved one was injured after using a testosterone supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a Testosterone Suit and we can help.

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