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FDA requires labeling changes for testosterone therapies to reflect CV risk
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The FDA has announced that manufacturers of prescription testosterone products must change their labeling to more clearly indicate approved uses and also include a warning about possible increased risk for MI and stroke.
According to a FDA drug safety communication, the agency recommends that health care professionals prescribe testosterone therapy only for men with laboratory confirmed low testosterone as a result of certain medical conditions of the brain, pituitary gland or testicles that result in hypogonadism. This is the only patient population for which these products have been approved.
The benefits and safety of testosterone therapy have yet to be confirmed among patients with low levels due to aging, even if the patient presents with symptoms that appear related to low testosterone. Patients should also be informed of possible CV risks when determining whether to initiate or continue testosterone therapy, according to the announcement.
The labeling change follows a review of available evidence from studies, as well as input from FDA advisory committee meetings, which led the agency to conclude that testosterone use may carry increased risk for CV events. Results from some, but not all, of the evaluated studies indicated increased risk for MI, stroke or mortality with testosterone therapy, according to the announcement.