Executive Summary

The U.K.'s Medicines and Healthcare products Regulatory Agency bolsters its labeling and packaging advice for manufacturers of OTC pain relief products with codeine or dihydrocodeine. In a Sept. 2 1letter to industry and pharmacists, the agency recommends warnings about overuse of the drugs be moved to the front of packaging and that codeine/DHC products be capped at 32-count size. Previous voluntary label and packaging changes for the products instituted in 2005 "have not proved effective" in reducing overuse, MHRA notes (2"The Tan Sheet" Aug. 22, 2005). The Proprietary Association of Great Britain, representing OTC manufacturers, said Sept. 3 it supports the advice recommended by MHRA's Commission on Human Medicines and its member companies already restrict codeine/DHC product packs to 32 tablets. MHRA's advice applies to U.K. OTC brands including Reckitt Benckiser's Nurofen Plus and GlaxoSmithKline's Panadol Ultra and Solpadeine Max, PAGB said