TGA safety warning on promethazine

Australia’s Therapeutic Goods Administration (TGA) yesterday warned that health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under six years of age.

This updated advice follows a TGA investigation and advice from the Advisory Committee on Medicines (ACM) in 2022, with warnings published in a previous Medicines Safety Update: first-generation oral sedating antihistamines – do not use in children.

The TGA noted that the pharmaceutical company Sanofi-Aventis Healthcare, a part of French pharma major Sanofi (Euronext: SAN), requested the latest updates to its Product Information (PI), Consumer Medicine Information (CMI) and product label for its product Phenergan, following an internal investigation prompted by the ACM advice.