June 27, 2012
Nonconvulsive status epilepticus has occurred in patients taking cefepime, an injectible cephalosporin. Most cases were reported in patients with renal impairment when the cefepime dosage was not adjusted appropriately. Fifty-nine cases of nonconvulsive status epilepticus in patients taking cefepime were reported to FDA from the time the drug was approved in 1996 through February, 2012. Most patients (58/59) had renal impairment, 69% were female, and 56% were over the age of 65. In 56/59 patients, cefepime was not renally dosed according to the recommendations in the product label. Most cases of nonconvulsive status epilepticus resolved following discontinuation of cefepime or initiation of hemodialysis. The cefepime product label will be revised to include more information about the risk of nonconvulsive status epilepticus.
When cefepime is administered to patients with creatinine clearance of 60 mL/minute or less, reduce the dosage according to the recommendations in the product label. Monitor patients taking cefepime for symptoms of status epilepticus (eg, confusion, altered mental status). If a patient develops seizures during cefepime therapy, ensure the dose is appropriate and consider discontinuing treatment. Report any adverse events associated with cefepime use to FDA MedWatch at http://www.fda.gov/medwatch/report.htm.
Additional information is available at the following links:
- MedWatch Alert:
- Drug Safety Communication:
- Cefepime (Maxipime®) prescribing information:
June 27, 2012. University of Utah Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, Utah.