FDA Announcement Regarding Acetaminophen in Prescription Drugs
Posted January 21, 2011
Late last week, the FDA announced that it has asked manufacturers of prescription products that contain an acetaminophen combination to limit the amount of acetaminophen in these products to no more than 325mg per dose. Currently, some of these medications contain 500 mg or 750 mg per dose. The decision was made in an effort to reduce the number of overdoses from prescription combination products containing acetaminophen. Most of the cases of acute liver injury occur in patients who take more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, or who take more than one of these products at a time, or drink alcohol while taking these products. It is overdoses from these combination formulations that account for nearly half of all cases of acetaminophen related liver failure in the United States.
Acetaminophen poisoning is a leading cause of liver failure in this country, with an estimated 400 associated deaths each year. In addition to the concerning mortality numbers, many more cases result in severe liver injury leading to the need for liver transplant. As a result, manufacturers of these products are also now being required by the FDA to add a black box warning label to the product, indicating the risk of severe liver failure. It is believed these two actions will provide the initial steps necessary to address the growing concerns of acetaminophen toxicity. Consumers will see changes in these products as the ruling is phased in over the next three years. Over-the-counter options, including combination products found in cough and cold formulations are not affected by the FDA decision.
The FDA recognizes the role of nurses and other healthcare providers in educating patients, including older adults, about the safe use of acetaminophen. In addition to safety monitoring and education among facility staff, the following recommendations are made:
Daily maximum for acetaminophen is 4 g for older adults
A 50% to 75% reduction in the daily maximum should be made for older adults with hepatic insufficiency or a history of alcohol abuse
Educate older adults, particularly those who are nearing discharge, about the correct dosing frequency for acetaminophen-containing products
Assure that older adults in your care understand that having three or more alcoholic drinks per day can raise the risk of acetaminophen toxicity
Address the concerns around taking multiple products containing the same active ingredients
Additional references:
Young, S. (2011, January). FDA limits amount of acetaminophen in prescription drugs. Retrieved January 18, 2011 from http://pagingdrgupta.blogs.cnn.com/2011/01/13/fda-limits-amount-of-acetaminophen-in-prescription-drugs/
American Geriatrics Society (2009). Pharmacological management of persistent pain in older persons. Journal of the American Geriatrics Society, 57(8), 1331-1346.