The rule requires manufacturers to label all testosterone products to warn of “a possible increased risk of heart attacks and strokes,” and to clarify they are not approved to treat the effects of normal ageing.
The agency also directed makers of 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.” It is encouraging rival manufacturers to work together on a study, but said they are allowed to work separately if they wish.
The regulation arose after an FDA Advisory Committee found studies and expert input associate testosterone with a possible increased cardiovascular risk. Some studies showed an increased risk of heart attack, stroke, and death, although others did not. Participants included ageing men treated with testosterone.
The FDA cautioned that testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions – such as hypogonadism, genetic problems, or damage from chemotherapy or infection – and not by normal ageing. However testosterone “is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging,” said the agency.
“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.”
New labels must reflect this and clarify approved uses of the medications.
The FDA simultaneously warned doctors to prescribe testosterone therapy only to men with an underlying medical condition confirmed by lab tests. Physicians must also make patients aware of the risks of testosterone products.