FDA informs of Label Change for Cefepime
Published: Jun 27, 2012
The U.S. Food and drug Administration (FDA) is informing health care professionals of a label change for Cefepime. According to the FDA there have been cases of a specific type of seizure called nonconvulsive status epilepticus associated with the use of cefepime, primarily in patients with renal impairment who did not receive appropriate dosage adjustments of cefepime. 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 the medical literature and have been identified in FDA's Adverse Event Reporting System (AERS) database. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment; however, some cases occurred in patients receiving dosage adjustment appropriate for their degree of renal impairment. In the majority of cases, the seizures were reversible and resolved after discontinuing cefepime and/or after hemodialysis. See the Drug Safety Communication for additional information.
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