FDA Warns Testosterone Products Increase Blood Pressure Risks

Credit: Adobe Stock/grinny

The U.S. Food and Drug Administration (FDA) has updated labeling for all testosterone products following the results of the phase four TRAVERSE trial and required ambulatory blood pressure monitoring (ABPM) studies.

The FDA only approves the use of testosterone products for men who lack or have low testosterone levels in combination with a related medical condition. Products that contain testosterone — an essential hormone for the development of male growth and masculine characteristics — are available in an oral formulation, topical gel, buccal system, transdermal patch and injection.

Required changes based on the results of the TRAVERSE trial included the following:

• Adding the results of the TRAVERSE trial to all testosterone products
• Retaining “Limitation of Use” language for age-related hypogonadism
• Removing language from the Boxed Warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products

Changes to current labeling language based on the results of the ABPM studies included the following:

• Adding product-specific information on increased blood pressure for testosterone products with completed ABPM studies
• Adding a new warning about increased blood pressure for testosterone products that do not currently have that warning in their labeling

In September 2014, the FDA convened a Joint Meeting of the Bone, Reproductive and Urologic Drugs and the Drug Safety and Risk Management Advisory Committee after reports of heart attack, stroke and death among men receiving FDA-approved testosterone treatment. This led to the initiation of the TRAVERSE trial, an industry-wide study designed to determine the safety of testosterone use in men with age-related insufficient sex hormone production (hypogonadism). Results of the trial were submitted in 2023 and showed no increased risk of adverse cardiovascular outcomes.

In 2016 and 2017, ABPM studies were recommended by the FDA as a part of the premarket development of two testosterone products that were administered via subcutaneous injection and orally. Both of these studies revealed testosterone could result in increased blood pressure. In March 2018, the FDA required ABPM studies for all testosterone products. These studies confirmed increases in blood pressure with all testosterone products, class-wide.