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FDA Imposes Stricter Regulations on Testosterone Treatment Therapy Manufacturers

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On September 17, 2014, an expert panel advised the Food and Drug Administration to enforce more regulations on testosterone treatment therapy drugs. Currently it is easy to get a prescription for testosterone therapy drugs and many men use them for low testosterone levels that occur naturally because of older age. The expert panel recommended stricter regulations including reducing prescription and “clamping down” on marketing of these drugs, and medical insurance companies.

FDA Investigating Risk of Adverse Effects in Men Taking a form of Testosterone Treatment Therapy

The FDA announced plans to investigate the risk of heart attack, stroke and death in men using a form of testosterone treatment therapy on January 31, 2014. The investigation was sparked by two studies. The Journal of the American Medical Association (JAMA) study found a 30% increase in the risk of heart attack, stroke and death in men who used a form of testosterone therapy. Another study published in PLOS One, found that men 65+ had twice the risk of a heart attack, stroke or death and younger men with a history of heart problems had three times the risk.

In its investigation, the FDA reiterated that testosterone is only approved for use in men with low testosterone coupled with an underlying medical condition.

But, the New York Times article highlights that doctors can “prescribe the drugs as they see fit.” Even if the FDA implements the expert panel’s recommendations, it’s not clear how much of an impact the new rules would have on prescriptions and usage.

An article in Reuters said that the advisory panel also recommends more studies to “assess the cardiovascular risk of their products for patients with age-related low testosterone.”

Only a doctor can determine whether or not you have a medical need for testosterone treatment therapy. Make sure that he or she is aware of your past and current medical history to lessen the chance of you suffering from an adverse effect. Never take more of a drug than prescribed and don’t let others use your prescriptions.

Testosterone Therapy Lawsuits

Hundreds of personal injury lawsuits have been filed by men who have suffered serious adverse effects from taking a form of testosterone treatment therapy. All federal cases were consolidated in June 2014 into the Northern District of Illinois by the U.S. Judicial Panel on Multidistrict Litigation (JPML).

If you or a loved one have suffered serious or fatal consequences after using a form of testosterone treatment therapy including heart attack, stroke, or death, you need an experienced lawyer to help you get the compensation you deserve. Contact a testosterone therapy attorney today for a free consultation.