Infant's death prompts TGA to act on antihistamines

The drug is behind 45 reports of adverse events in children under two

Oral sedating antihistamines will soon carry mandatory safety warnings for babies, following a string of adverse events.

The TGA says it is moving to force all OTC sedating antihistamine medicines, including promethazine oral liquid products, to update their packaging with the statement:

"Do not give to children under two years of age."

The regulator will also work with manufacturers to strengthen warnings in product information and consumer medicines information sheets.

The move comes after the death of a 74-day-old infant, who had been given OTC promethazine oral liquid, a phenothiazine-derived long-acting antihistamine with mild atropine-like anticholignergic effects.

A coroner reviewing the case did not directly blame the antihistamine for the baby’s death, but said there was concern about the risk of respiratory depression when promethazine