The Medicines and Healthcare products Regulatory Agency (MHRA) has announced 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. This follows the MHRA’s thorough review of the benefits and risks of these medicines.
On advice from the Commission on Human Medicines (CHM), the new package represents a proportionate move to improving the balance of risks and benefits for these medicines. People using these products for children, or have used them in the past, do not need to worry. 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 our 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.
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 ‘Birth to Five’. For 6 to 12 year olds 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. More research is being done by industry on how well these medicines work in children aged 6-12 years.
