Health authorities have issued a warning against the use of the oral antihistamine promethazine hydrochloride in children under six years of age.
The medication, sold under the brand name Phenergan by manufacturer Sanofi, is commonly used to treat allergic conditions such as hay fever or rashes, treat adults with difficulty sleeping and act as a sedative for children aged six years and above.
New scientific evidence about the risks associated with its use in younger children has since prompted health officials to restrict its use in this age group.
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“Sanofi-Aventis Healthcare’s benefit-risk review of the cumulative safety data in children between two to five years of age (inclusive) found that the cumulative weight of evidence was sufficient to support a causal association between promethazine (and combinations) and safety concerns relating to psychiatric and central nervous system events,” the Therapeutic Goods Administration (TGA) said.
Children under six years of age could experience side effects such as hyperactivity, aggression and hallucination.
When high doses are given, these children may also experience difficulties in learning and understanding, such as reversible cognitive deficit and intellectual disability.
New labels for promethazine-containing products will need to be updated on almost 50 other brands.
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Oral promethazine products are currently available as S3 products which can be given to patients over-the-counter on advice from pharmacists.
The TGA indicated there may be a delay before updated package labelling is updated on all products available in pharmacies.
In the meantime, parents and carers are advised to seek alternative products for children under six years of age.
