Revised SPC: Audavate (betamethasone) 0.1% w/w Cream
Sections 4.4 and 4.8 have been updated to include information about the risks and characteristics of topical steroid withdrawal reactions, which the MHRA has requested be added to the SPCs and patient information leaflets of all topical corticosteroid medicines.
Source:
electronic Medicines compendium
SPS commentary:
The MHRA has conducted a review of the evidence for topical steroid withdrawal reactions, including data from 55 Yellow Card reports and information available in the literature and from other regulators. Healthcare professionals are advised to consider the lowest potency needed when prescribing a topical corticosteroid, and to advise patients on the amount of product to apply and how long they should use it for.