The Patient Counseling Information/Patient Information/Medication Guide for the topical testosterone gel Axiron has been updated to include clarifications such as ensuring patients know how to administer the correct dosage as well as understanding that they should not drink the product.
Axiron is a testosterone supplement intended for men with low levels of the male hormone due to injury or disease. It is a topical gel that is applied to the armpits. Patients are advised to wash their hands right away with soap and water after applying the gel and, once the solution has dried, to cover the area with clothing to prevent unintended exposure to others, such as women and children.
Signs of testosterone exposure in children include enlarged penis or clitoris, early development of pubic hair, increased erections or sex drive, and aggressive behavior. Signs of testosterone exposure in women include changes in body hair, and a large increase in acne.
The new patient information for Axiron informs patients that the pump should be primed by depressing or twisting it three times before first use and that no priming is necessary for subsequent uses. Patients may also use an antiperspirant or deodorant spray before applying Axiron, but should allow at least two minutes for the deodorant to dry before applying Axiron to avoid contaminating the roll-on or stick deodorant product.
The patient information also includes the advice “Do not drink Axiron.” For starters, the body would not absorb the medicine through the stomach, according to Health Tap. Secondly, testosterone taken orally can harm the liver. Oral testosterone products are in development but have yet to receive FDA clearance.
Axiron’s safety label update comes just as the Axiron maker Eli Lilly and Co. faces lawsuits – along with other testosterone treatment manufacturers – over cardiovascular risks. Trials are currently underway involving AbbVie’s top selling AndroGel. Two cases involving Eli Lilly’s Axiron were selected earlier this month to serve as bellwethers among more than 6,000 lawsuits in a multidistrict litigation pending in the U.S. District Court for the Northern District of Illinois.
FDA Drug Safety Label Changes