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

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In response to an article from the May 2007 issue of the Lancet Infectious Diseases, the Food and Drug Administration (FDA) has undertaken a review of safety data pertaining to cefepime (Maxipime), a broad spectrum antibiotic in the [beta]-lactam class approved in 1996. The article indicates that the all-cause mortality rate is higher in patients treated with cefepime, compared with those treated with other [beta]-lactam antibiotics. It will take several months for the FDA to complete the review, and at present, revisions to the drug labeling have not been proposed. Nurses should monitor and assess patients taking cefepime for any deterioration in health and report to the prescriber accordingly.


The FDA has also begun a safety review of varenicline (Chantix), a prescription drug used to assist smoking cessation in adults. Varenicline, approved for sale in May 2006, works by binding to a particular subset of nicotinic receptors. The FDA review was prompted by reports submitted by the manufacturer (Pfizer) describing suicidal ideation associated with use of the drug and a postmarketing case report of erratic behavior. Another reported adverse effect of varenicline is drowsiness. After analysis of all data concerning the drug is completed, the FDA will communicate its findings and recommendations to the public. For the present, nurses should monitor patients taking varenicline for changes in mood or behavior. Education provided to the patient and family should include information on the risk of suicidal ideation and the instruction to contact the prescribing physician if changes in mood or behavior are observed. Also, nurses should instruct patients beginning varenicline therapy to avoid driving and operating machinery until they have determined whether the drug causes them to be somnolent.


Center for Drug Evaluation and Research. Early communication about an ongoing safety review Cefepime (marketed as Maxipime). Rockville, MD: U.S. Food and Drug Administration; 2007 Nov 14.


FDA issues early communication for Chantix [press release]. FDA News 2007 Nov 20.


Yahav D, et al. Lancet Infect Dis 2007;7(5):338-48.