Australia’s Therapeutic Goods Administration (TGA) has issued a critical safety warning regarding the use of Phenergan (promethazine hydrochloride) in children under six years old. Parents have been advised to immediately stop using the popular antihistamine following evidence of severe psychiatric and neurological side effects in young children.Key Findings from the Investigation
The TGA, Australia’s medicine watchdog, updated the Product Information (PI) and Consumer Medicine Information (CMI) documents after an internal investigation by the pharmaceutical company Sanofi-Aventis Healthcare, supported by TGA’s Advisory Committee on Medicines.
The safety warning highlights the following risks in children under six:

• Psychiatric side effects: Hyperactivity, aggression, hallucinations

• Cognitive effects: Reversible cognitive deficits and intellectual disabilities

• Severe outcomes with high doses: Difficulty in learning and understanding

Phenergan, commonly used to treat allergies, hay fever, nausea, and for short-term sedation, is available over-the-counter but requires pharmacist advice. The updated guidelines prohibit its use in children below six years.Broader Implications

• Product Scope: This warning extends beyond Phenergan to include 50+ other promethazine hydrochloride-based products on the Australian market. Manufacturers of these products are required to update their safety labels and PI/CMI documents.

• Healthcare Guidance: Pharmacists must counsel caregivers, emphasizing that these medicines should not be administered to children under six years, even if previously recommended.

The TGA acknowledged there might be a delay in updated labels reaching pharmacies but emphasized that the revised guidelines are effective immediately.Expert Statement
According to the TGA, “These findings underscore the importance of ensuring that parents and caregivers are well-informed about the potential risks of using promethazine hydrochloride for children under six.”
Director-General V.B. Kamalasan Reddy reiterated the need for health professionals to educate parents on the revised guidelines to ensure public safety.