Acne cream goes OTC despite dermatologists’ warning
Down-scheduling of the retinoid product will 'inevitably' lead to lawsuits, TGA told
Pharmacists will be able to prescribe 0.1% adapalene for acne under an interim decision of the TGA, at odds with advice from dermatologists.
The OTC listing of the topical retinoid for treatment of adolescents and adults is one of several recent down-scheduling decisions, following on from changes to triptans and mometasone.
The most significant concern over changing the drug to Schedule 3 was teratogenicity but other evidence suggested topical use of up to 150 times the maximum dose had no teratogenic effect “indicating a margin of safety”, the TGA said.
Prescription adapalene has been classed in Australia as a Category D medicine for pregnant women.
