(MedPage Today) – A boxed warning for testosterone on major adverse cardiovascular events is out and a new blood pressure warning is in, the FDA announced late last week as part of a class-wide labeling update for all testosterone products.

Prompted by a review of the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial, the agency recommended removing language from the long-standing boxed warning on all testosterone products related to an increased risk of major adverse cardiovascular events, including myocardial infarction, stroke, and cardiovascular death. TRAVERSE findings should also be added to all labels, the agency added, and “limitation of use” language for age-related hypogonadism should be retained. (Read More)