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March 3, 2015: FDA Requires Testosterone Labeling Changes and Clinical Trials

Testosterone Lawsuit Help – The Law Firm of Eric H. Weinberg is assisting men injured by the side effects of testosterone therapy. If you have suffered a testosterone side effect including a heart attack, stroke, blood clots, or pulmonary embolism, and have a question regarding your legal rights, please contact us for a free testosterone lawsuit case evaluation toll free at 1-877-934-6274.

FDA Testosterone Safety Announcement

On March 3, 2015, The U.S. Food and Drug Administration (FDA) cautioned the public that prescription testosterone products are approved only to treat low testosterone levels that have been caused by certain medical conditions in men. These conditions include disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. Examples of these disorders include failure of the testicles to produce testosterone because of genetic problems, or damage from chemotherapy or infection.

The FDA further cautioned that the benefit and safety of testosterone products have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.

FDA Mandates Testosterone Labeling Changes and Clinical Trials

Based on its findings, the FDA is requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use. Manufacturers of approved testosterone products will also be required to conduct trials to address the question of whether an increased risk of heart attack or stroke exists among testosterone product users.

FDA Advice to Health Care Professionals and Patients Regarding Testosterone Use

The FDA cautioned that health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. The FDA stated that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging, and that the benefits and safety of this use have not been established.

The FDA advises that patients who are using testosterone products should seek medical attention immediately if symptoms of a heart attack or stroke are present, including:

  • Chest pain
  • Shortness of breath or trouble breathing
  • Weakness in one part or one side of the body
  • Slurred speech

Report Testosterone Side Effects To The FDA

Patients and health care professionals are urged to report testosterone side effects to the FDA’s MedWatch drug safety reporting program.

Contact Attorney Eric Weinberg For A Testosterone Lawsuit Evaluation

Since 1984, Attorney Eric Weinberg has represented personal injury victims, including those injured by dangerous pharmaceutical products. The firm has obtained over $850 million on behalf of clients. We are ready to help you too. If you or a loved one has suffered a testosterone side effect, including heart attack, stroke, blood clots, pulmonary embolism, or death you may be entitled to financial compensation. For a free and non-obligatory testosterone lawsuit evaluation, please call The Weinberg Law Firm 24/7, toll free at 1-877-934-6274.

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