FDA’s Nonprescription Drug Advisory Committee and two other advisory panels will meet in June to discuss risk management solutions and other possible responses to the public health problem of liver injuries linked to the use of acetaminophen in both OTC and prescription products.
The Drug Safety and Risk Management and the Anesthetic and Life Support Drugs advisory committees will join the NDAC in the meeting June 29-30 in Adelphi, Md., a Washington suburb.
In a notice prepared for the April 24 Federal Register, FDA said a Center for Drug Evaluation and Research multidisciplinary working group appointed in 2007 is expected to issue a report May 22 recommending additional steps the agency could take to decrease the number of acetaminophen-related liver injuries.
FDA said “given the complex nature of the underlying problem of acetaminophen liver toxicity,” CDER Director Janet Woodcock and the working group agreed that the options identified in the report should be presented for public discussion prior to taking further action.
According to the notice, in its deliberations the working group considered detailed reviews from the Office of Nonprescription Products, the Office of Surveillance and Epidemiology and the Division of Anesthesia and Analgesic and Rheumatology Drug Products.
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