The FDA is requiring label changes for all approved prescription testosterone products to clarify the approved uses of these medications after increased heart risks associated with use has surfaced.
They are also requiring manufacturers of approved testosterone products to conduct a "well-designed" clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products.
According to the FDA, the benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.
"We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications," said the agency. "We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone.
"Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests."
When it comes to the clinical trial, the agency is encouraging these manufacturers to work together on a clinical trial, but they are allowed to work separately if they so choose.
