引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
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| Australia: Promethazine hydrochloride (Phenergan) not to be used in children under 6 (English only) |
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The Therapeutic Goods Administration (TGA) announces that health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under 6 years of age.
This updated advice follows a TGA investigation and advice from the Advisory Committee on Medicines (ACM) in 2022, with warnings published in a previous Medicines Safety Update: first-generation oral sedating antihistamines - do not use in children.
The pharmaceutical company Sanofi-Aventis Healthcare requested the latest updates to its Product Information (PI), Consumer Medicine Information (CMI) and product label for its product Phenergan, following an internal investigation prompted by the ACM advice.
The PI and CMI documents have been updated to include the risks of psychiatric and central nervous system side effects in children under 6, including hyperactivity, aggression and hallucination. When high doses are given, these children may also experience difficulties in learning and understanding, including reversible cognitive deficit and intellectual disability.
Sanofi-Aventis Healthcare’s benefit-risk review of the cumulative safety data in children between 2 to 5 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.
Phenergan is used to treat a range of conditions including allergies, hayfever and nausea, as well as for short-term sedation.
There are almost 50 other brands of oral promethazine hydrochloride on the Australian market and the sponsors of these products will also be required to update their PI and CMI documents, and product labelling. Oral promethazine products are currently scheduled S3, which means they can be sold over-the-counter with advice from a pharmacist.
Health professionals should be alert to the updated advice and appropriately counsel parents and carers who may intend to use Phenergan or another oral promethazine product in a child under 6 years old. These parents and carers should be directed to alternative products.
The TGA expects 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.
At this stage, the updated advice does not apply to the single intravenous form of promethazine hydrochloride on the Australian market, noting that this product is only available with a prescription from a doctor.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/promethazine-hydrochloride-phenergan-not-be-used-children-under-6
In Hong Kong, there are 236 registered oral pharmaceutical products containing promethazine. So far, with regard to promethazine, the Department of Health (DH) has received 5 cases of adverse drug reaction, but these cases were not related to psychiatric and central nervous system event in children under the age of 6. Related news was previously issued by the TGA, and was posted on the Drug Office website on 13 Jul 2022. In light of the above TGA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, Nov 20, 2024
Issued at HKT 15:30
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