其 他 安 全 警 示
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| Australia: First-generation oral sedating antihistamines - do not use in children (English only) |
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Therapeutic Goods Administration (TGA) announces that with the arrival of winter and flu season in Australia, consumers and health professionals are reminded that first-generation oral sedating antihistamines, including those available over-the-counter (OTC), should not be used for the treatment of cough, cold and flu symptoms in children under 6 years. First-generation oral sedating antihistamines should not be given to children under 2 years of age for any indication. These medicines can cause children serious harm, or even death, and there is little if any evidence that they are effective in treating cough, cold and flu symptoms.
Since 1 September 2020, all OTC products containing first-generation oral sedating antihistamines have been required to carry warnings that state 'Do not give to children under 2 years of age'. Oral preparations for coughs, cold or flu must also carry warnings stating: 'Do not give to children under 6 years of age' and 'should only be given to children aged 6 to 11 years on the advice of a doctor, pharmacist or nurse practitioner'.
The TGA's independent Advisory Committee on Medicines (ACM) has advised that there is minimal if any evidence supporting efficacy of first-generation oral sedating antihistamines for allergic rhinitis and cough and cold symptoms in children.
The committee reinforced the importance of health professionals providing thoughtful diagnosis, advice and treatment of allergy, cold and flu symptoms in children. They also reiterated that it is inappropriate to use antihistamines for sleep and behaviour disturbance, especially in children and adolescents.
To 24 May 2022, 226 cases involving use of first-generation oral sedating antihistamines in newborns, infants and children were reported to the TGA. The reports included a range of adverse events, including hypersensitivity reactions, vomiting, hallucination, tremor and abnormal movement. Of the 226 cases, 20 related to off-label use, misuse or overdose in children 4 years and under.
First-generation oral sedating antihistamines include products containing the following active ingredients:
• alimemazine (trimeprazine)
• brompheniramine
• chlorphenamine
• dexchlorpheniramine
• diphenydramine
• doxylamine
• pheniramine
• promethazine
• triprolidine
These products are indicated for multiple conditions, including the treatment of symptoms for cold, flu, cough and allergy.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/first-generation-oral-sedating-antihistamines-do-not-use-children
In Hong Kong, there are registered oral pharmaceutical products containing brompheniramine (103 products), chlorphenamine (788 products), dexchlorpheniramine (106 products), diphenydramine (61 products), doxylamine (2 products), pheniramine (2 products), promethazine (237 products) and triprolidine (43 products). They are all non-prescription medicines, except doxylamine which is a prescription-only medicine. There is no registered pharmaceutical product containing alimemazine (trimeprazine).
So far, the Department of Health (DH) has received one adverse drug reaction report related to brompheniramine for children under 2 years of age, which involved abnormal movement of the eyeball. In light of the above TGA’s announcement, letters to inform local healthcare professionals will be issued, and the DH will remain vigilant on any safety update of the drugs issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Wednesday, Jul 13, 2022
Issued at HKT 19:30
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