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FDA Requests Blood Clot Warnings on Labels of Testosterone Supplements

The Food and Drug Administration recently stated that all testosterone replacement therapy products should include a warning about the risk of blood clots on their labeling.

The Food and Drug Administration recently stated that all testosterone replacement therapy (TRT) products should include a warning about the risk of blood clots on their labeling. In addition to blood clots, recent studies have linked testosterone supplements to heart attacks, strokes, pulmonary embolisms and even sudden death. However, despite these risks, testosterone boosters have been gaining in popularity in recent years, and are now prescribed to nearly 3% of American men over the age of 40.

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?

In a Drug Safety Communication issued June 19, 2014, FDA stated that while testosterone supplements already carry a warning about the risk of venous blood clots as a possible consequence of polycythemia (increased red blood cell count), the latest reports involve clots that are unrelated to polycythemia. According to the FDA:

“Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products.”

Approved testosterone replacement therapy products include:

Because blood clots unrelated to polycythemia occur in the veins, the new warning is not related to FDA’s ongoing research into the link between testosterone supplements and cardiovascular side effects including heart attack, stroke and death.

Studies Link Testosterone Boosters to Cardiovascular Side Effects

In November of 2013, research published in the Journal of the American Medical Association found that older men who took testosterone, as well as younger ones with pre-existing heart problems, were at an increased risk of having a heart attack, stroke, blood clot or dying suddenly. Two months after the JAMA study came out, additional research in the journal PLOS ONE found that TRT products may double the risk of heart attack in young men with prior heart problems, as well as in men aged 65 or older with no pre-existing heart problems. The results of the two studies prompted the FDA to launch an investigation into the potential health risks of testosterone supplementation.

Can I File a Testosterone Lawsuit?

Only a qualified attorney can determine whether you are eligible to file a Testosterone Lawsuit, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.

Most cases involving pharmaceuticals allege that a product was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a potential side effect. In the case of testosterone, our attorneys suspect that patients may be able to take legal action in light of claims that manufacturers failed to adequately warn doctors and patients about the risk of cardiovascular side effects including heart attack, stroke, blood clot, pulmonary embolism and death.

How Can Filing a Lawsuit Help Me?

By filing a Testosterone Lawsuit, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your injury, as well as for damages for pain and suffering. Additionally, filing a lawsuit can help hold the bone cement’s manufacturer accountable for releasing an allegedly defective product into the marketplace, and to discourage other pharmaceutical companies from engaging in similar conduct.

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 blood clot cases in all 50 states.

Free Testosterone Blood Clot Lawsuit Evaluation: If you or a loved one developed a blood clot after taking 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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