MOUNT PROSPECT, Ill. — The National Association of Boards of Pharmacy on Wednesday recommended that pharmacies no longer dispense combination drugs containing more than 325 mg of acetaminophen per dosage unit in light of recent regulatory action.
NABP also advises that pharmacists consult with prescribers to discuss alternative products with lower acetaminophen doses.
The Food and Drug Administration is withdrawing approval of 108 abbreviated new drug applications for prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit. For the 108 ANDAs, the manufacturers asked to withdraw their applications, as announced in the March 27, 2014 Federal Register notice. A second Federal Register notice addresses the applications of six manufacturers who have discontinued marketing their products, but who have not withdrawn their applications.
The notice also announces FDA’s intention to begin the process of withdrawing approval of those applications.
FDA asked manufacturers to voluntarily withdraw these products from the market to reduce the risk of severe liver injury from inadvertent acetaminophen overdose. In January 2014, FDA recommended that providers consider prescribing acetaminophen products containing 325 mg or less per dose.