Cefepime Seizure Risk in Kidney Patients

Washington, DC: The FDA has alerted health care professionals to a label change for Cefepime. The issue is reported 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 FDA has announced that 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' 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.

Symptoms of nonconvulsive status epilepticus could include altered mental status, confusion, and decreased responsiveness.

Legal Help

If you or a loved one has suffered illness or damages in this case, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Published on Jun-26-12