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    Posted September 5, 2014 by
    localinsight
    Location
    Los Angeles, California

    FDA Panel To Review Testosterone Therapy Appropriateness and Safety

     

    On September 17th, 2014, Committee Members for the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRMAC) will meet jointly to discuss study findings from the Food and Drug Administration’s (FDA) review of the use of testosterone replacement therapy or (TRT). Specifically, the FDA will be looking for feedback about the appropriate population for TRT and will also be looking at clinical data that may suggest an increased risk of cardiac arrest or other cardiovascular-related adverse health events for those patients who have received TRT.


    While the use of TRT for treating low testosterone has been around since the 1950’s, only within the last several years has its use skyrocketed, in part due to direct-to-consumer advertising for non-specific age-related maladies. Non-branded advertising has espoused the benefits of treating testosterone deficiency, explaining that all men lose testosterone as they age and that treating “Low T” can result in increased vitality, vigor, and strength.

     

    Indeed, the FDA brief released on September 3rd indicates that from 2009 to 2013, there was a 65% increase in the amount of testosterone sold and that from 2010-2013, the number of patients receiving TRT had risen from 1.3 million to 2.3 million patients – a 77% increase. The study analyzed health insurance claim data to reveal that only half of those prescribed TRT had been diagnosed with the condition that TRT is approved to treat, moreover, 21% never had their serum testosterone levels tested at all, either to establish a baseline to determine appropriateness of TRT therapy, nor to determine whether serum levels had improved after treatment. The report concludes that: “the increased use of testosterone in older men indicate that TRT use has expanded significantly and appears to include … asymptomatic individuals with low serum testosterone concentrations, and symptomatic men with normal or unknown serum testosterone concentrations. As mentioned previously, treatment benefits with TRT for ‘age-related hypogonadism’ remain questionable, and there are no reliable data on the benefit in such a population.” (emphasis added).


    This review comes at a pivotal time for the TRT industry. More than 200 lawsuits are pending against manufacturers of testosterone replacement medicines such as AndroGel, Androderm, Axiron and Testrim. Defendants named include Eli Lily, Abbott Laboratories and AbbVie and Endopharmaceuticals. Plaintiffs allege that the drug has caused cardiovascular injury including deep vein thrombosis (DVT), pulmonary embolism, stroke and heart attack. In an effort to organize and expedite legal proceedings, multi-district litigation may be used since plaintiffs and defendants are geographically dispersed. A FaceBook Page about the testosterone lawsuit has been created to disseminate information on this fast-moving story and provide a connection point for affected individuals and their family members.

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