UK watchdog cautions parents giving cold and cough medicines to children
02 Mar 2009
The UK watchdog has cautioned parents against giving over-the-counter (OTC) cough and cold medicines for children under 12 years old as they came into use when clinical trials were not required to demonstrate that they worked in children.
Following a thorough review of the benefits and risks of these medicines, the Medicines and Healthcare Products Regulatory Agency (MHRA) said that it has come out with a comprehensive package of measures to promote the safer use of over-the-counter (OTC) cough and cold medicines for children under 12 years old.
On advice from the Commission on Human Medicines (CHM), the new package represents a proportionate move to improve the balance of risks and benefits for these medicines.
It has advised parents using these products for children, or have used them in the past, not to worry and neither do shelves need to be cleared.
The MHRA review did not identify in this age-group the safety issues of the kind which prompted its action in under-2s in March 2008. But the review found "no robust evidence that these medicines work and they can cause side effects, such as allergic reactions, effects on sleep or hallucinations", the atchdog panel said.
Parents and carers should no longer use OTC cough and cold medicines containing the ingredients reviewed in children under 6. They should follow advice to relieve symptoms as outlined in the Department of Health's 2007 guidance for children in the age bracket from 'birth to five'.
These medicines will continue to be available but will only be sold in pharmacies, with clearer advice on the packaging and from the pharmacist. This is because the risks of side effects is reduced in older children because they weigh more, get fewer colds and can say if the medicine is doing any good.
It also said that more research is being done by industry on how well these medicines work in children aged 6-12 years.
MHRA director of vigilance and risk management of medicines, Dr June Raine said, ''Coughs and colds can be distressing for both you and your child but they will get better by themselves within a few days. Using simple measures to ease symptoms is likely to be most effective.
''Over-the-counter medicines used to treat coughs and colds have been used for many years. However they came into use when clinical trials were not required to demonstrate that they worked in children. This means they were not specially designed for children.
''It is not right to assume safety and efficacy based on children being 'small adults'. Children should have access to medicines that are acceptably safe and designed for their use.''
The MHRA is working with industry and healthcare professionals to encourage 'best practice' and implement these measures. Industry has agreed to implement changes over a period of time.
They will make the necessary labeling changes to state that these medicines should not be used in children under 6, introduce updated labeling, and to change the legal status of medicines authorised for children aged 6 – 12 years from general sale (GSL) to pharmacy.
Newly labelled products will start to appear for the 2009 cough and cold season. Medicines with the old labeling will not be cleared off shelves.This is because many of these products are used in adults and children, and so cannot be withdrawn, creating a shortage of these medicines.
Withdrawing these medicines would not be proportionate compared to the risk of side effects. These changes should be completed by March 2010.
