Drugs regulators warn against giving codeine to children
|
Version 0 of 1. The EU’s pharmaceuticals regulator has warned that childen under 12 years of age should not take codeine for the treatment of coughs and colds. Breast-feeding mothers should also not take codeine as a precaution against harming their babies, the European Medicines Agency (EMA) said on Friday. Related: Paracetamol may dull emotions as well as physical pain, new study shows Restrictions introduced in 2013 meant the medicine should generally only be taken for pain relief by people over 12 and, even then, only if alternatives such as paracetamol or ibuprofen do not work. The agency has warned that codeine, an opioid, should not be used to treat coughs and colds in under-12s because of mounting concerns over its conversion into morphine. The latest guidance regarding treament of coughs is stronger than that for pain relief because doctors are being told codeine is contra-indicated for the age group, effectively banning them from using it except under special circumstances. There was a serious risk of side-effects from codeine, including breathing problems, the EMA said. Older children and adolescents who had breathing problems should also not use codeine, nor should patients of any age who were known to convert codeine into morphine at a faster rate than normal. EMA’s new advice was endorsed by the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s safety watchdog. “This is important advice about the use of codeine to treat cough and cold in children. Whilst codeine is not commonly used in children, the evidence is clear that there is a risk of side effects,” the MHRA said. “If anyone has any questions, they should speak to their GP or pharmacist who can best advise on alternative treatments.” Related: Scientists identify opium poppy codeine and morphine genes EMA’s advice comes after a review of evidence by one of its committees, which said morphine-related side-effects in under-12s were more variable and unpredictable than in older patients. Evidence that codeine was effective in treating coughs among the age group was also limited. The review of international data relating to coughs and other respiratory infection found 17 cases, including four deaths, arising from codeine intoxication in children aged between 17 days and six years. However, EMA said it could not yet release details of the size of population or time period involved in the review. The agency said parents and carers should also immediately stop giving codeine to patients of any age and seek immediate medical help if they showed symptoms including slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation or lack of appetite. |