FDA Drug Review News
Advisory Panel to the FDA Recommends Prescription Acne Medication be Available Over-the-Counter
In mid-April, an advisory panel to the U.S. Food and Drug Administration (FDA) voted 16 to 0 that the prescription topical acne agent adapalene gel 0.1% (Differin®) was safe for over-the-counter (OTC) use. However questions persist on the labeling of the product due to concerns regarding its safety in women who are pregnant or may become pregnant. Overall adapalene is thought to have a low risk of birth defects and wide margin of safety.
Adapalene is a topical retinoid derived from vitamin A and is used once daily. It is FDA-approved for the treatment of acne in adults and children ages 12 and older. It is estimated 85% of adolescents and 12% of adult women are affected with acne, and over-the-counter availability of this medication would be expected to help a significant portion of patients suffering from acne.