Australia’s medicines watchdog says parents should immediately stop using a popular oral antihistamine, used to treat allergies, hay fever and nausea.
The Therapeutic Good Administration (TGA) has issued a safety alert, warning that promethazine hydrochloride, sold as Phenergan, should not be given to children under six years old.
The TGA said there’s a risk of ‘psychiatric and central nervous system side effects in children under six, including 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’.
Phenergan is used to treat allergies, hay fever and nausea, and is also used for short-term sedation.
“There are almost 50 other brands of oral promethazine hydrochloride on the Australian market and these sponsors will also be required to update their PI and CMI documents, and product labelling,” the TGA explained.
“Oral promethazine products are currently available as S3 products which can be given to patients over-the-counter on advice from pharmacists.
“We expect there will be a time lag before all products available in pharmacies will have updated package labelling. In the interim, the updated advice to not use oral promethazine medicines in children under the age of 6 years applies across all products.”
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BellaB said
- 23 Nov 2024
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Ellen replied
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Ellen replied
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