The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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.
Safety information
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.
Product information
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.
Further reading
The Therapeutic Goods Administration (TGA) has previously published information about this issue, most recently in a 20 March 2018 Medicines Safety Update article.
What to report? You don't need to be certain, just suspicious!
The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.
We particularly request reports of:
- all suspected reactions to new medicines (look for the Black Triangle in PI and CMI documents - this symbol identifies medicines that are new or being used differently)
- all suspected medicines interactions
- suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.
Reports may be submitted:
- online at www.tga.gov.au
- by fax to 02 6232 8392
- by email to ADR.Reports@tga.gov.au
For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.
Disclaimer
Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.
© Commonwealth of Australia 2021
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For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance and Special Access Branch at ADR.Reports@tga.gov.au.
Medicines Safety Update is written by staff from the Pharmacovigilance and Special Access Branch.
Editor: Ms Elspeth Kay
Deputy Editor: Mr Michael Pittman
Contributors: Ms Sarah May, Mr Gilbert Yeap and Dr Steph Cheung