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.
With the arrival of winter and flu season in Australia, children are more likely to suffer cough, cold and flu symptoms. While it is understandable that parents want to treat those ailments, first-generation oral sedating antihistamines are not appropriate.
Since 1 September 2020, all OTC products containing first-generation oral sedating antihistamines that are indicated for use in children 2 years and above 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 that are indicated for use in children 6 years and above must 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.
Adverse event reports
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:
These products are indicated for multiple conditions, including the treatment of symptoms for cold, flu, cough and allergy.
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