FOLLOWING a coronial hearing of a fatal case involving a 74-day old infant being given over-the-counter (OTC) promethazine oral liquid, the Therapeutic Goods Administration (TGA) has issued a Medicines Safety Update to alert pharmacists.
Promethazine oral liquid is a phenothiazine derivative that is a long-acting antihistamine with mild atropine-like anticholinergic effects and some anti-serotonin effects, and while the coroner did not attribute the baby's death directly to the product, there was a concern expressed around the risk of associated fatal respiratory depression.
The coroner warned that the product should not be given to children under two years of age.
Other OTC products identified by the TGA as containing first-generation sedating antihistamines include brompheniramine, chlorpheniramine, dexchlorpheniramine, diphenhydramine, doxylamine, pheniramine, alimemazine (trimeprazine) and triprolidine.
The agency added that there had been 45 reports of adverse events in children aged under two years in which a first-generation oral sedating anti-histamine is listed as the sole-suspected medicine.
Read the full TGA statement and recommendations at tga.gov.au.
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