FDA Updated the Labeling for Testosterone and Removed the Warning on Cardiovascular Risk

[RoidNewsGuy]

The U.S. Food and Drug Administration (FDA) has implemented significant labeling changes for all testosterone products, reflecting recent clinical findings. These updates involve the removal of the boxed warning concerning major adverse cardiovascular events and the introduction of warnings about increased blood pressure.

Background on Testosterone Therapy​

Testosterone therapy is prescribed to men with hypogonadism—a condition characterized by low testosterone levels due to specific medical conditions affecting the testicles, pituitary gland, or brain. FDA-approved testosterone formulations include oral tablets, topical gels, transdermal patches, buccal systems (applied to the upper gum or inner cheek), and injections.

Key Findings from the TRAVERSE Clinical Trial​

The TRAVERSE (Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men) trial was a large-scale study designed to evaluate the cardiovascular safety of testosterone therapy in men with hypogonadism and either established or high risk for cardiovascular disease. The trial concluded that testosterone-replacement therapy was noninferior to placebo regarding the incidence of major adverse cardiac events (MACE), including myocardial infarction, stroke, and cardiovascular death.
Over a 33-month period, 7% of men on testosterone experienced a MACE compared to 7.3% on placebo.

FDA's Labeling Revisions Based on TRAVERSE Findings​

In light of the TRAVERSE trial results, the FDA has recommended the following labeling changes for all testosterone products:

• Removal of Boxed Warning: The previous boxed warning about an increased risk of adverse cardiovascular outcomes has been eliminated.
• Inclusion of TRAVERSE Trial Results: Labels will now incorporate findings from the TRAVERSE trial, providing healthcare professionals and patients with updated information on the cardiovascular safety of testosterone therapy.
• Retention of "Limitation of Use" Language: The labeling will continue to specify that testosterone therapy is not approved for age-related hypogonadism, emphasizing its use only in men with low testosterone levels due to specific medical conditions.

Introduction of Blood Pressure Warnings​

Postmarket ambulatory blood pressure monitoring (ABPM) studies have indicated a class-wide increase in blood pressure associated with testosterone use. Consequently, the FDA is mandating the following updates:

• Product-Specific Blood Pressure Information: For testosterone products with completed ABPM studies, labels must include detailed information about the potential for increased blood pressure.
• New Blood Pressure Warning: Products that currently lack warnings about increased blood pressure are now required to add such information to their labeling.

Implications for Healthcare Professionals and Patients​

Healthcare providers should be aware of these labeling changes and consider both the benefits and potential risks when prescribing testosterone therapy. Patients should be informed about the possibility of increased blood pressure and the importance of monitoring cardiovascular health during treatment. Despite the removal of the boxed warning on cardiovascular events, vigilance in assessing individual risk factors remains essential.

Sources​

https://www.fda.gov/drugs/drug-safe...s-wide-labeling-changes-testosterone-products
https://www.medpagetoday.com/endocrinology/steroids/114458