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U.K. advises against OTC codeine use for all children

This article was originally published in The Tan Sheet

Executive Summary

The U.K. changes labeling for codeine-containing nonprescription drugs to recommend against use by children under 18 years old. The Medicines and Healthcare products Regulatory Agency 1noted the change Oct. 11 after a review by the advisory Commission on Human Medicines found "a lack of robust evidence supporting the efficacy of codeine in cough suppression in children." The CHM, working with its Pediatric Medicines Expert Advisory Group to review OTC cough and cold products for children, in 2009 recommended children under 6 years old not use antitussive codeine drugs (2"The Tan Sheet" March 9, 2009). After additional codeine safety and efficacy studies, the experts advised extending the recommendation to all children under 18. The change, which will appear in 2011 on labels for antitussive codeine drugs, follows MHRA's 2009 requirement for more prominent warnings about misuse of codeine nonprescription pain relief products (3"The Tan Sheet" Sept. 7, 2009, In Brief). All nonprescription codeine products in the U.K. remain available only from pharmacists

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