The recent over-the-counter (OTC) approval of Differin Gel 0.1% (adapalene) marks the first time since the 1980s that a new active ingredient for acne treatment has been available to consumers without a prescription.
The approval of Differin is also significant since it the first retinoid acne product to be approved for OTC use. Retinoids have a storied history as prescription medications due to a possible increased risk of birth defects in pregnant women who have used retinoid creams, especially Retin-A (tretinoin). The retinoid pill, Accutane (isotretinoin), is also linked to birth defects.
Adapalene is considered a third-generation retinoid, while tretinoin and isotretinoin are first-generation.
Because of this issue, the FDA is advising that women who are pregnant, planning to become pregnant, or breast-feeding should consult a doctor before using Differin.
“While there have been no adequate and well-controlled studies of Differin Gel 0.1% in pregnant women, there is no specific evidence that Differin Gel 0.1%, when used topically as directed, causes birth defects in humans,” the agency said. “Some other retinoid drugs have been shown to cause birth defects.”
The product labeling for Differin Gel 0.3%, a stronger, prescription-only version of the gel that was approved back in 1996, contains a warning that exposure to sunlight should be minimized while using the gel. In addition, it states that in rodents and rats, an oral version of adapalene was associated with an increased risk of birth defects. However, the label also says that there have been no “adequate, well-controlled” studies of adaplene in pregnant women.
Post-marketing experience with the prescription version of Differin has shown a number of adverse events, including skin irritation, face edema, lip swelling and angioedema.