Kidney patients risk seizures from Cefepime, an intravenous antibacterial medication used to treat pneumonia and urinary tract, skin, and intra-abdominal infections, said the U.S. Food & Drug Administration (FDA). Cefepime is typically administered to hospitalized patients; however, some patients may receive Cefepime at home, following hospital discharge.
The agency indicated that there have been reports of a specific type of seizure—nonconvulsive status epilepticus—linked to Cefepime use and mostly seen in patients with renal impairment who received inappropriate dosage adjustments. The Warnings and Precautions and Adverse Reactions sections of the Cefepime label are being revised to highlight this risk.
Cases of nonconvulsive status epilepticus associated with Cefepime are documented in medical literature and identified in the FDA’s Adverse Event Reporting System (AERS) database. Most were reported in patients with renal impairment who did not receive appropriate dosage adjustment; however, some occurred in patients whose dosage adjustment was appropriate for their degree of renal impairment. Seizures were usually reversible and resolved after discontinuing Cefepime and/or after administering hemodialysis.
The FDA’s AERS database revealed that from 1996 through February 2012, 59 cases of nonconvulsive status epilepticus during Cefepime administration were reported; 56% involved patients over the age of 65 years (the age range was 7 – 95) and 69% involved female patients. According to FDA research, patients who developed signs of neurotoxicity with Cefepime were typically 50 years of age or older, had underlying renal dysfunction, and, often, did not receive appropriate dosage adjustments.
Renal dysfunction was present in 58 patients; renal status was unknown in one patient. In 56 patients, Cefepime dosing was not appropriately adjusted for renal impairment and the seizure was resolved in 43 patients. Of the 16 patients who died, some had underlying central nervous system disease or a prior history of seizures on other beta-lactam antibacterial drugs or cephalosporins.
Health care professionals are advised to adjust Cefepime dosage in patients with creatinine clearance less than or equal to 60 mL/min. If seizures associated with Cefepime therapy occur, health care professionals should consider discontinuing Cefepime or making appropriate dosage adjustments in patients with renal impairment. Caregivers who notice symptoms of nonconvulsive status epilepticus—altered mental status, confusion, decreased responsiveness—in a patient receiving Cefepime are advised to seek immediate medical attention.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA via its MedWatch Safety Information and Adverse Event Reporting System. Complete and submit the report online at www.fda.gov/MedWatch/report.htm or download the form from http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call the FDA, toll-free, at 1.800.332.1088 to request a reporting form and complete and return to the address on the pre-addressed form or send by fax to 1.800.FDA.0178.