On Friday, April 15, the Nonprescription Drugs Advisory Committee of the FDA voted unanimously to recommend over-the-counter usage of adapalene gel .01%, an acne topical medication that has been in use for decades. The drug is derived from Vitamin A and manufactured by Swiss firm Galderma. All 16 members of the committee found that the data indicated the drug was safe enough to be distributed OTC.
One concern that went unresolved is the possible need for a label warning for pregnant women to consult a physician. In animal studies done using a much higher level of the drug than would occur with normal topical use, birth defects were observed. Committee members could not agree on whether to include a warning label or not, or how strong the warning should be.
The committee also considered three studies with human participants documenting actual usage and label comprehension. The FDA is not bound by the committee’s findings, but often follows them. Adapalene gel is currently available in 82 countries, but only OTC in Russia.
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Acne Drug: FDA Advisors Recommend OTC Adapalene