Australia: The oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be given to children under 6 years of age.
The pharmaceutical company Sanofi-Aventis Healthcare requested the latest updates to advice in the Product Information (PI), Consumer Medicine Information (CMI) and product label for Phenergan, following an internal investigation. This was prompted by a TGA investigation and advice from our Advisory Committee on Medicines.
The PI and CMI documents have been updated to include the risks of psychiatric and central nervous system side effects in children under 6, including hyperactivity, aggression and hallucination. When high doses are given, these children may also experience difficulties in learning and understanding, such as reversible cognitive deficit and intellectual disability.
Phenergan is used to treat a range of conditions including allergies, hayfever and nausea, as well as for short-term sedation.
There are almost 50 other brands of oral promethazine hydrochloride on the Australian market and these sponsors will also be required to update their PI and CMI documents, and product labelling.
Oral promethazine products are currently available as S3 products which can be given to patients over-the-counter on advice from pharmacists.
For more information see Medicines Safety Update: Promethazine hydrochloride (Phenergan) not to be used in children under 6.
