U.K. To Move Kids’ Cough/Cold Drugs BTC, Redraws Age Recommendation
This article was originally published in The Tan Sheet
Executive Summary
Manufacturers of pediatric cough/cold medicines sold in the U.K. have until March 2010 before the products must be sold behind the pharmacy counter, one of several measures to improve safe use
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U.K. advises against OTC codeine use for all children
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
U.K. sets timetable for containers
Firms marketing nonprescription liquid cough and cold drugs in the U.K. must submit to health regulators by Feb. 12, 2010, plans for the child-resistant containers required by September 2010. The Medicines and Healthcare products Regulatory Agency Oct. 27 said it intends to approve changes by the end of March. MHRA imposed the regulation, which covers pharmacy-only and general-sale antihistamines, antitussives, expectorants and decongestants, following a comprehensive efficacy and safety review of children's cough/cold products. MHRA in February 2008 said children under 6 should not use OTC cough/cold products because of efficacy and safety concerns (1"The Tan Sheet" March 9, 2009)