FDA Meets to Assess Low-T Health Risks

If you are currently or considering undergoing testosterone replacement therapy, stay tuned. In a combined meeting with two advisory committees, the FDA will be spending today and tomorrow assessing the associated health risks, determining who is being prescribed such medication, and considering an application for a new oral Low T medication, as opposed to current drugs which are administered as gels, injections or implants.

The meeting, which is being held in Hyattsville, Maryland, follows a "safety announcement" in January this year that the FDA was "investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products". While the FDA is not legally required to follow the recommendations of advisory committees, it usually does. Besides patients and doctors, the outcome will impact at least the 12 pharmaceutical companies that collaborated to submit a paper to the advisory committees.

While T-therapy is FDA approved for the treatment of hypogonadism, a disorder where a man's body is incapable of producing testosterone, the new T-therapy products are being marketed at men aged 40-64 who simply have dropping T levels as a result of the aging process. In just three years, between 2010 and 2013, around one million more patients have been prescribed Low T replacement therapy, according to the materials that have been released in advance of the meeting. At this time, the FDA has instructed patients not to stop taking the prescribed products without first consulting a healthcare professional, but also warned that those "professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment."

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