27: FDA Updates Labeling and Safety Information For Testosterone Products

The FDA is updating the labeling for all FDA-approved testosterone products (oral, topical gel, transdermal patch, buccal system, and injection) based on the TRAVERSE trial and ABPM studies. The results of the TRAVERSE trial are being added to all testosterone product labels, and the language in the Boxed Warning related to an increased risk of adverse cardiovascular outcomes will be removed from all testosterone products. The TRAVERSE trial found no increased risk of adverse cardiovascular outcomes in men using testosterone for hypogonadism. However, the "Limitation of Use" language for age-related hypogonadism is being retained. A new warning about increased blood pressure is being added to products without such a warning. Furthermore, product-specific information on increased blood pressure will be included for products with completed ABPM studies. ABPM studies confirmed an increase in blood pressure with the use of all testosterone products. These actions follow prior FDA warnings about the risks of stroke, heart attack, and death in men taking testosterone products. Testosterone is only approved for use in men with low testosterone levels in conjunction with an associated medical condition. Hosted on Acast. See acast.com/privacy for more information.