1. Aschenbrenner, Diane S. MS, APRN-BC


* Acetaminophen labeling will warn of possible serious liver damage and of a possible interaction with warfarin causing internal bleeding.


* The labeling of NSAIDs will warn of the risks of gastric bleeding and of renal failure in the presence of cirrhosis.



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The Food and Drug Administration (FDA) announced on April 28 that manufacturers of over-the-counter analgesics and antipyretics are required to revise the labeling of their products before April 29, 2010, to include warnings about possible serious adverse effects. (See and for more information.) The medications concerned are acetaminophen and the nonsteroidal antiinflammatory drugs (NSAIDs) aspirin, ibuprofen, naproxen, and ketoprofen.


Some sources have noted that intentional or unintentional acetaminophen overdosage is the most common cause of acute liver failure in the United States. Manufacturers of acetaminophen and of combination products containing it (cold medicines containing pain relievers or fever reducers), will be required to prominently state the risk of severe liver damage caused by high doses of the drug or if the patient takes three or more alcoholic drinks per day. Further, the labeling now must also include a warning that the patient should consult the physician if she or he is taking warfarin, because acetaminophen can increase the risk of internal bleeding posed by the anticoagulant. (On June 30 an FDA advisory committee met to "address the public health problem of liver injury related to the use of acetaminophen" and recommended the elimination of combination drugs containing the drug and the lowering of its maximum daily dosage, among other limits. The FDA hadn't acted on the recommendations at press time. See for more information.)


It is now mandatory that NSAID product labeling contain the warning that the drugs pose the risk of gastric bleeding and that this risk is increased in patients taking anticoagulants or steroids, in those who either take more than one NSAID concurrently or who take one or more for longer than directed, and in those who drink more than three alcoholic beverages daily. Further, on NSAID product labeling, where the patient is advised to consult the physician before using the product in the presence of certain conditions and circumstances, liver cirrhosis will be added to the list because patients with liver cirrhosis and ascites, a severe form of liver disease, are at risk for developing renal failure from NSAID use. Finally, manufacturers are required to prominently display the active ingredients of products on all product labeling, including packages, inserts, and bottles.


The purpose of the revisions is, of course, to correct inappropriate use of the drugs by consumers. Nurses play an important role in educating patients and their families on the safe use of over-the-counter medications. Understanding the present drug labeling changes will help them provide the most up-to-date and pertinent information.


Bower WA, et al. Am J Gastroenterol 2007;102(11):2459-63.