Proposed OTC Acetaminophen Warnings Not Supported By Science – McNeil
This article was originally published in The Tan Sheet
Executive Summary
Existing science on the safety and efficacy of OTC acetaminophen does not substantiate several FDA-proposed warnings to be included in labeling for the analgesic, McNeil Consumer Healthcare asserts
You may also be interested in...
FDA Expands Acetaminophen, NSAID Labeling Beyond Tentative Final Rule
FDA's final rule for OTC products containing acetaminophen or nonsteroidal anti-inflammatory drugs requires warnings and revisions that go beyond changes the agency proposed in a 2006 tentative final rule
Final rule for pain reliever labels
FDA has prepared a final rule to require that acetaminophen-containing and non-steroidal anti-inflammatory OTC drugs carry updated warnings on adverse gastrointestinal and hepatic side effects linked to improper use. The 1rule slated for publication in the Jan. 26 Federal Register amends FDA's labeling regulations and the tentative final monograph on nonprescription internal analgesic, anti-pyretic and anti-rheumatic drug products. The compliance deadline is one year from the date of publication. FDA's December 2006 proposed rule raised industry concerns that more flexibility was needed and that some of the changes were not supported by science (2"The Tan Sheet" June 11, 2007, p. 3). While some of the Consumer Healthcare Products Association's comments were not adopted for the rule, the trade group said Jan. 23 that its members already voluntarily have implemented "many of these label changes," including highlighting the active ingredient
Top Stories Of 2007: From Talk Of BTC To Supplement GMPs
The past year offered anticipated changes and moves as well as some unexpected thrills and chills for the nonprescription drugs and nutritional products industries