Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS104615

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel