The European Medicines Agency (EMA) has announced that codeine is not to be used for coughs or colds in children under 12 years of age. The restriction is one of two measures introduced by the CMDh, a European intergovernmental health committee, to minimize the risk of serious side effects in children taking codeine-containing drugs. The other measure is a recommendation against codeine use in patients aged 12 to 18 years who have breathing problems.
The new measures come after a review by the EMA’s Pharmacovigilance Risk Assessment Committee. The review brought up the unpredictability of how codeine is converted into morphine in children below the age of 12. It further considered that children who have breathing problems maybe more susceptible to respiratory complications resulting from codeine use. Finally, it has not been convincingly demonstrated that codeine is effective in treating coughs and colds, thus tipping the risk/benefit scales away from unnecessary codeine use.
The CMDh has also announced that codeine is not to be used in patients of any age who convert codeine into morphine at a faster-than-normal rate (ultra-rapid metabolizers), or in breastfeeding mothers, as codeine can be transmitted to babies through breast milk.
This new review follows another by the same agency, which warned against codeine use for pain relief in children after tonsillectomy or adenoidectomy procedures. The U.S. Food and Drug Administration released a similar safety communication, which resulted in the updating of labels of codeine-containing drugs.
Tell your doctor or physician about any health concerns you may have. If you or someone you know sustained a serious injury after using a codeine-containing product, contact the pharmaceutical lawyers at Lopez McHugh for a free consultation. You may qualify for legal compensation.