FDAnews Drug Daily Bulletin

Salix Gets FDA Warning for Metozolv Advertising

April 9, 2010
Salix Pharmaceuticals has received an FDA warning letter about promotional materials for its Metozolv orally disintegrating tablets (ODT) that omit risk information and suggest the drug is safer and more effective than evidence has demonstrated. One promotional piece for the drug entirely omits risk information, according to a March 19 letter from the Division of Drug Marketing, Advertising and Communications. Yet Metozolv ODT’s (metoclopramide HCl) prescribing information contains a boxed warning about tardive dyskinesia, a movement disorder.
Washington Drug Letter