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FDA Limits Acetaminophen in Prescription Drug Products

A longstanding challenge faced in managing cancer and cancer treatment toxicities is poly-pharmacy. People with cancer are cared for by multiple practitioners throughout their disease trajectory and when combined with the availability of a vast array of over-the counter (OTC) products, duplicative and overlapping medications may be purchased and/or prescribed. The risk of this practice can lead to puzzling or life-threatening sequelae.

On January 13, 2011 the United States Food and Drug Administration (FDA) mandated that manufacturers of prescription products containing acetaminophen limit the amount to 325 milligrams or less in each tablet.1  Additionally, the FDA is requiring manufacturers to update drug labels of all medications containing acetaminophen, warning of the risk of liver injury. The rationale for this direction is related to the increased rates of liver failure in the United States, many linked to higher-dose prescription combination acetaminophen products.

Acetaminophen, also called APAP, is a component of several prescribed pain medications such as Tylenol® with codeine, Percocet® and Vicodin®. It is also available in many OTC products; however these were not addressed in the recent FDA ruling. For a full listing of affected products, please visit: www.fda.gov/acetaminophen

ManageCRC Commentary

Nurses are keenly positioned to review patient medication profiles and ascertain maximum dosing or duplicative medications. This starts with direct review, reading each patient’s medication, dose and frequency during each encounter. Oftentimes it is insufficient to just ask, “Have there been any changes to your medication list?” It is imperative that patients are encouraged to report any OTC medications they are taking. Acetaminophen can be a hidden ingredient which could compound toxicities when taken with prescribed medicines containing acetaminophen. Encouraging patients to maintain a personal list of medications that they update regularly after any health care provider appointment is instrumental in staying abreast of any changes as well as avoiding toxic outcomes. In addition to expert nursing assessment and care, the FDA ruling is a welcome and appropriate safeguard to minimizing toxicities and improving patient outcomes.


U.S. Food and Drug Administration, Access to the press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239894.htm

Article Created On : 2/28/2011 1:43:00 PM             Article Updated On : 2/28/2011 1:43:00 PM