With the arrival of winter and flu season, consumers and health professionals are reminded that first-generation 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 antihistamines should not be given to children under 2 years of age for any indication.
First-generation antihistamines were introduced in the 1940s and are still used today. These products work by affecting the histamine receptors in the brain and spinal cord. They go through the blood-brain barrier and can cause sleepiness.
By contrast, second-generation antihistamines were first developed in the 1980s. They cause less sleepiness than first-generation antihistamines and interact with fewer medications.
First-generation antihistamines include products containing the following active ingredients:
- alimemazine (trimeprazine)
- brompheniramine
- chlorphenamine
- dexchlorpheniramine
- diphenydramine
- doxylamine
- pheniramine
- promethazine
- triprolidine.
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'.
Information for consumers
Do not use first-generation antihistamines in children under 6 years of age for the treatment of cough, cold and flu symptoms. Do not give first-generation antihistamines to children under 2 years of age for any reason. These products can cause serious harm in young children.
Information about treating cold and flu symptoms is available from Healthdirect and NPSMedicinewise. You can also ask your doctor or pharmacist for advice on the best treatments for coughs, cold and flu.
Additionally, using first-generation antihistamines for sleep and behaviour disturbance, especially in children and adolescents, can be dangerous and is strongly discouraged.
Information for health professionals
The TGA has published a Medicines Safety Update article about this issue, providing more detailed information for health professionals.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.