ISSUE 1 FEBRUARY
Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 19 November 2024.
Summary
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 6 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 pharmaceutical company Sanofi-Aventis Healthcare 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.
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, including 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 the sponsors of these products will also be required to update their PI and CMI documents, and product labelling.
Oral promethazine products are currently scheduled S3, which means they can be sold over-the-counter with advice from a pharmacist.
What health professionals should do
Health professionals should be alert to the updated advice and appropriately counsel parents and carers who may intend to use Phenergan or another oral promethazine product in a child under 6 years old.
These parents and carers should be directed to alternative products.
We [the TGA] expect there will be a time lag before all products available in pharmacies will have updated package labelling. In the interim, the updated advice to not use oral promethazine medicines in children under the age of 6 years applies across all products.
At this stage, the updated advice does not apply to the single intravenous form of promethazine hydrochloride on the Australian market, noting that this product is only available with a prescription from a doctor.
See the full article on the TGA website.
