Promethazine Safety Update

The Therapeutic Goods Administration (TGA) has issued a safety alert for oral promethazine hydrochloride. The product information (PI) and consumer medicine information (CMI) documents for Phenergan® have been updated to state that it must not be given to children under six years of age. Sponsors of all other brands of promethazine will also be required to update their PI, CMI, and product labelling accordingly.

This alert strengthens previous advice to not give first-generation oral sedating antihistamines to children under six for the relief of cold and flu symptoms or to children under two years for any indication. A review of safety data supports a causal association between promethazine and safety concerns in children under six years. Psychiatric and central nervous system adverse effects in this population may include hyperactivity, aggression, and hallucination. In children under two, there are reports of respiratory depression resulting in death.

This safety alert applies to all oral promethazine products. These products can be purchased without a prescription, and there will likely be a significant time lag before all labelling is updated. Healthcare professionals should be alert to this issue and counsel parents and carers who may intend to give promethazine to a child. Advice on alternative products, such as non-sedating antihistamines or non-pharmacological therapies, may be provided where appropriate.

This updated advice does not currently apply to the injectable form of promethazine, although this product is prescription-only.