Promethazine hydrochloride (Phenergan) not to be used in children under 6

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 temporary cognitive deficits, reversible upon stopping use.

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 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.

Background

The registered therapeutic indications (reasons for use) for Phenergan are:

• Allergies: Treatment of allergic conditions including some allergic reactions to drugs, urticaria and allergic contact dermatitis, and allergic reactions to insect bites and stings.
• Upper respiratory tract: Relief of excessive secretion in the upper respiratory tract as a result of hayfever and allergic rhinitis.
• Nausea and vomiting: Antiemetic for vomiting from various causes, including postoperative vomiting, irradiation sickness, drug induced nausea and motion sickness.
• Sedation: For short term use under the advice of a doctor or pharmacist. Do not use for more than 7 to 10 consecutive days.
• Other: Promethazine has sedative effects and can be used in the symptomatic management of measles and chicken pox.
• Preanaesthetic medication for the prevention and control of post operative vomiting.

Sanofi-Aventis Healthcare’s benefit-risk review of the cumulative safety data in children between 2 to 5 years of age (inclusive) found that the cumulative weight of evidence was sufficient to support a causal association between promethazine (and combinations) and safety concerns relating to psychiatric and central nervous system events.

Changes to the PI

Sections 4.2 and 4.3

• Extension of the contraindication from children less than 2 years to children less than 6 years of age, and an amendment to dosing as a result.

Section 4.4

• Update to the warnings and precautions section to reflect the safety information updated in all other sections.

Section 4.8

• Update to the psychiatric and central nervous system adverse events section to include aggression, hallucination and psychomotor hyperactivity in children less than 6 years of age.

Section 4.9

• Update to the overdose section to include reversible intellectual disability and cognition deficit in case of overdose in children less than 6 years of age.

Disclaimer

Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.

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Medicines Safety Update is written by staff from our Pharmacovigilance Branch.

Editor: Dr Megan Hickie

Deputy Editor: Aaron Hall

Contributors: Gilbert Yeap and Bec Page