Media Release
2 March 2009
Children’s Use of Cough and Cold Medicines Reviewed
Please attribute to Dr Stewart Jessamine, Group Manager Medsafe.
Medsafe's advice that children under two shouldn't be given cough and cold medicines will be looked at again in light of the UK's move to advise against use for children under six.
The New Zealand advice was changed last year and the warning labels on cough and cold medicines will be appearing on shelves beginning this month.
Medsafe’s current advice is that cough and cold medicines should never be given to children aged under two years and when given to older children extra care should be taken.
Both Canada and the UK have recently strengthened their advice further – advising against the use of these products in children under six.
The Canadian and United Kingdom advice is based on an assessment of possible harm compared to benefit. Both countries’ regulatory agencies have decided the reports of harm – it appears mostly from unintentional overdose in children – and the limited evidence of benefit is behind the change.
Medsafe says its current advice stands, but it will be seeking the reports on which the latest decisions were made and reviewing them to see if a similar approach is warranted here.
There have been very few reports of adverse reactions in children from these medicines in New Zealand, however, the National Poisons Centre has received a number of calls about overdoses of cough and cold medicines in children under two years requiring medical attention.
Medsafe’s current advice to parents:
Do not use cough and cold medicines in children aged under two years.
For children over two years:
If it is necessary to give a cough and cold product to a child, make sure that you read all labels and instructions before doing so. If the product does not contain dose information for children, then it should not be used in children.
Do not give a child a larger dose than is recommended. Do not use the product more frequently than is recommended in the labelling and instructions.
Take care not to unintentionally overdose your child. Note all the medicinal ingredients in the product, particularly if you may be giving more than one product to a child. Be aware that many products contain the same medicinal ingredient(s) and combined use could lead to overdose. Some over-the-counter medications used to control fever may also have medicinal ingredients similar to those in other cough and cold products.
Because cough and cold medications often contain multiple ingredients, it is advised not to give more than one cough and cold product to a child.
Talk to your doctor or healthcare practitioner if you have questions about the proper use of these products, dosing and administration information, or the medicinal ingredients in the products you are using.
There is no cure for the common cold. Children will usually recover from coughs and colds in time on their own. The common cold is a mild, viral infection that can be managed by rest, sufficient fluid intake and comfort measures.
In young children and babies, it is sometimes important to rule out serious illnesses (for example, pneumonia or other infections) which may present with cold-like signs and symptoms; this is especially important if symptoms persist or if the child’s condition deteriorates.
If you are concerned about your child’s health, the child should be brought to a healthcare practitioner for medical evaluation.
Links:
A link to The United Kingdom’s Medicine and Healthcare Products Regulatory Agency (MHRA) advice:
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON038902
A link to the Health Canada advice on this issue:
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_184-eng.php
A link to the US Center for Disease Control and Prevention advice on this issue – note US advice is these products should not be given to children under four:
http://www.cdc.gov/Features/PediatricColdMeds/
Background:
Medsafe is the Ministry of Health’s drug regulatory arm. Medsafe assesses all medicines for their safety and effectiveness.
It is estimated that there are more than 100 cough and cold medicines available in New Zealand. The following active ingredients are currently used in cough and cold medicines in New Zealand:
- Expectorants (medicines that help a person cough up mucus): guaifenesin
- Mucolytics (medicines that dissolve or disperse mucus): bromhexine
- Decongestants (medicines that shrink swollen membranes in the nose): pseudoephedrine and phenylephrine
- Cough suppressants (medicines that act to suppress cough reflex): dextromethorphan and pholcodine
- Sedating antihistamines (drugs that block some of the reaction to histamines produced in the body eg clear blocked nose. These drugs frequently cause sleepiness): doxylamine, brompheniramine, chlorpheniramine, tripolidine, promethazine and diphenhydramine (NB this is also a cough suppressant)
For further information, please contact Media Advisor Michael Flyger: 04 496 2265 or 027 434 6878