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FDA Panel Recommends Tighter Restrictions on Testosterone Supplement Industry

A panel of medical experts has voted for the U.S. Food & Drug Administration to enforce more stringent regulations on the massive testosterone replacement therapy industry.

A panel of medical experts has voted for the U.S. Food & Drug Administration (FDA) to enforce more stringent regulations on the massive testosterone replacement therapy (TRT) industry. The panel recommended that FDA limit testosterone prescriptions to men with serious medical conditions (such as pituitary gland problems) and cut back usage for problems related to the natural aging process.

Free Testosterone Lawsuit Evaluation: If someone you know was injured by a testosterone supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the testosterone booster and we can help.

Expert Panel Recommends Limits on TRT Supplements

On September 17, 2014, the FDA panel voted overwhelmingly in favor of the agency tightening labels for testosterone boosters so they are no longer prescribed to men who only have problems related to aging, such as decreased energy and lack of sex drive.

“The whole idea is to try to rein in the inappropriate advertising and use of these drugs,” said Michael Domanski, director of heart failure research at Mount Sinai School of Medicine.

FDA officials had previously issued warning letters to sponsors over inappropriate and misleading testosterone advertising campaigns. The new reforms could also potentially limit coverage from insurance companies for TRT use.

However, some experts are skeptical that tighter restrictions would change much, because doctors can prescribe medications as they see fit, despite indications on the products’ labeling.

“Why did the FDA allow this huge push for the creation and the selling of ‘aging is optional for men,’ when we don’t know the benefits or harms?” asked Lisa Schwartz, a professor at the Dartmouth Institute for Health Policy and Clinical Practice.

Studies Identify Cardiovascular Risk of Testosterone Boosters

FDA is reassessing the safety of testosterone supplements in light of recent studies and is investigating rates of heart attack, stroke, blood clots and other severe cardiovascular complications in users of the drugs. In November 2013, a study published in the Journal of the American Medical Association suggested that Low T treatments may increase the risk of cardiovascular side effects in older men with pre-existing heart disease. Then in January 2014, a study in PLOS ONE found that testosterone supplements may double the risk of heart attack in younger men, as well as in older men regardless of their health status.

Can I File a Testosterone Lawsuit?

Only a qualified attorney can determine whether you are eligible to file a lawsuit against the manufacturer of a testosterone supplement, 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 drug was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect. In the case of testosterone replacement therapy (TRT) products, our attorneys suspect that patients may be able to take legal action in light of claims that the supplements’ manufacturers failed to adequately warn doctors and patients about the risk of heart attack and other severe cardiovascular side effects.

How Can Filing a Lawsuit Help Me?

By filing a lawsuit against the maker of a testosterone booster, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your heart attack or other health problem, as well as for damages for pain and suffering. Additionally, filing a lawsuit can help hold the drug’s manufacturer accountable for releasing an allegedly defective drug 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 injury and death cases in all 50 states.

Free Testosterone Lawsuit Evaluation: If you or a loved one has been injured by 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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