Revised: 29 May 2013

Safety Information

Use of Cough and Cold Medicines in Children - Updated advice

Questions and Answers on over-the-counter cough and cold medicines

Why have the Cough and Cold Review Group made these recommendations?

The Cough and Cold Review Group have recommended that oral cough and cold medicines, with the exception of those containing only bromhexine, should be contraindicated in children under six years of age. This is because the Group considered the balance of benefits and risks of these medicines in children to be unfavourable.

The factors which lead the Cough and Cold Review Group to make this recommendation were:

• The absence of evidence that these medicines have any beneficial effect in children.
• Evidence of serious side effects associated with these medicines in children.
• The risk of accidental overdose.
• The lack of need for treatment as the common cold will get better on its own.
• Evidence that infection with the common cold affects children and adults differently (as it was previously assumed that if these medicines worked in adults they would also work in children).

What does 'contraindication' mean?

A contraindication describes a particular patient group for whom the risks of taking a medicine outweigh the benefits and therefore the medicine should not be used in those patients. In this case the Cough and Cold Review Group have recommended that oral cough and cold medicines with the exception of those containing only bromhexine should not be used in children under six years of age.

Cough and cold medicines work in adults, why not in children?

The Cough and Cold Review Group have carefully reviewed the available data and concluded that there is no evidence to show that cough and cold medicines work in children.

At the time that these medicines were first used (1950s) it was assumed that infection with the common cold was the same in children and adults. It was also assumed that medicines used to treat symptoms of the common cold worked in the same way for all ages. There are now reasons to believe that infection with the common cold is not the same in children and adults.

As the common cold improves on its own, a medicine may seem to be helping when the child is actually just getting better on their own.

Further information is available on the Medsafe website at the following link:
Presentation on efficacy (Adobe PDF document 182 KB)

What is the evidence of harm from these medicines in children?

There have been international reports of rare, but serious, side effects associated with the use of cough and cold medicines in children. These side effects include convulsions, increased heart rate, decreased level of consciousness, allergic reactions, abnormal heart rhythms and hallucinations. There have been similar reports of side effects to these medicines in New Zealand.

Although these reports are infrequent, the Cough and Cold Review Group considered that children should not be exposed to the risk of serious side effects from medicines which have no evidence of benefit.

The Group considered that side effects from cough and cold medicines are probably under-reported because parents and healthcare professionals may not realise that the above effects could be caused by a cough and cold medicine.

Further information is available on the Medsafe website:
Presentation on safety (Adobe PDF document 243 KB)

In New Zealand you can report suspected side effects to any medicine to the Centre for Adverse Reactions Monitoring (CARM). Information on how to report side effects is available on the CARM website:
http://nzphvc.otago.ac.nz/report/.

Why were cough and cold medicines containing bromhexine and topical nasal decongestants as the only active ingredient excluded from the Group's recommendations?

The Cough and Cold Review Group considered that these medicines appear to be associated with a lower risk of causing serious side effects.

Are these medicines still safe and effective for adults and children six years and above?

Currently there are no safety concerns with the use of cough and cold medicines in adults. For children aged six years and above the risk from these medicines is reduced because they suffer from coughs and colds less frequently and they are heavier reducing the risk of accidental overdose. They can communicate better to say if the medicine is working.

As for all medicines it is an individual's decision whether the potential benefits of taking a medicine outweigh the risk of any side effects.

What is Medsafe doing now?

Medsafe is working closely with the sponsors of the affected cough and cold medicines to change the package labelling for these medicines to include advice not to use these medicines in children under six years of age. Medicines with the new labelling will be introduced gradually to avoid a shortage of these medicines for adult use. Medsafe will also ask the Medicines Classification Committee to review the classification of these medicines.

Is there any need to worry if a child has been given these medicines?

If a child has previously been given the dose recommended on the package labelling there is no need to worry. There is no evidence that children who have used these medicines in the past are still at risk from having taken them. Medsafe advises that you should no longer use cough and cold medicines in children under six years of age.

If you have any concerns, you should discuss them with your doctor or pharmacist.

What should I do with medicines already purchased for children under six years of age?

If you have medicines that you no longer need please take them to your local pharmacy for disposal.

Hasn't there already been action with cough and cold medicines in children?

In December 2007 the Medicines Adverse Reactions Committee reviewed the available data on the safety and efficacy of cough and cold medicines in children. The Committee considered that children less than two years of age were at greatest risk from side effects from cough and cold medicines. In addition there was no evidence of any benefit from using these medicines, and no adequate evidence detailing how much to give children this young. As a result the Committee recommended that cough and cold medicines be contraindicated for use in children less than two years of age. The Committee also recommended that further information be sought on the safety of these medicines in children aged two years and above, which has led to the current review.

Further information is available on the Medsafe website at the following link:
www.medsafe.govt.nz/profs/adverse/Minutes132.htm

Why were these medicines approved in the first place?

These medicines were available before the introduction of the modern regulation of medicines. When systems were put in place to regulate medicines, those already on the market were accepted as being safe and effective based on usage at the time. Since the 1960s scientific research has shown that children react to medicines differently to adults. In addition standards for the conduct of clinical trials and evidence of efficacy have changed.