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Tuesday, March 26th, 2019

Axiron Side Effects: New Study

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Axiron (Lilly) is one of the most recent testosterone medications to gain FDA approval for prescription sale in the United States. This came around the same time we saw approvals for Fortesta, Bio-T Gel, and AndroGel 1.62%. Axiron delivers the hormone testosterone through the skin like these other topical testosterone gels, although in this case it is applied to the underarms (axillae). This uniqueness surely explains the name AXIRON (AXIllae + testosteRONe). Axiron is very new, so user experiences and clinical data are still in their early stages. Adding to what we do know on this medicine, a clinical study was just released in the journal Current Medical Research & Opinion that reviews some of the common side effects, particularly with regard to dermatological issues (1).

The article in question reviews a recent phase 3 clinical trial with 71 hypogonadal men. The study ran for 180 days, during which time they applied Axiron 2% testosterone gel daily. The tail end of the study (60 days) was specifically focused on evaluating the skin safety of the medication. The men did well with the testosterone, though skin irritation was reported in a moderate percentage of patients. The most common dermatological side effect was application-site irritation, with 12 men reporting. All cases were mild except one, classified as moderate. Ten patients reported transient erythema (skin redness). Again, all cases were mild except one. Water retention (3 cases), acne (2 cases), and inflammation of the hair follicles (1 case) were reported as well. Overall, Axiron was well tolerated, leading to mild transient side effects in a minority of patients, and rarely at a level warranting drug cessation.

References:
(1) Skin reactions in a phase 3 study of a testosterone topical solution applied to the axilla in hypogonadal men. Muram D, Melby T, Kingshill EA. Curr Med Res Opin. 2012 Mar 29. [Epub ahead of print]

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