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."