Oral antihistamine may cause aggression or hallucinations in young kids: TGA
Phenergan maker Sanofi asked the TGA about updating the product information following a safety review.
Children younger than six should not use the S3 oral antihistamine promethazine due to risks of psychiatric or CNS adverse events, the TGA says.
Promethazine is indicated for allergies, hay fever and nausea, or as a short-term sedative.Â
A 2022 TGA investigation into the risks of first-generation sedating antihistamines spurred manufacturer Sanofi to conduct a safety review of its promethazine product Phenergan.
The review found that the drug could cause aggression, hallucinations and psychomotor hyperactivity in children younger than six and that overdose could cause reversible cognitive deficits, the company said.
