Decision

24 March 2016: Epiduo letter

Published 26 April 2016

MHRA received an anonymous complaint concerning a letter sent out by Galderma in April 2015 about the use of Epiduo (adapalene/benzoyl peroxide) in pregnancy. The complainant alleged that the letter was misleading as to the appropriate use of the product in women of child bearing age.

MHRA did not uphold the complaint because the letter was consistent with the SPC and quoted the relevant section in full. Epiduo should not be used in pregnancy but SPCs for adapalene products were amended in 2009 to remove restrictions on use in women of child bearing age.