Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

Cefepime:Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment

Audience: Health Professional,Infectious Disease, Nephrology



Issue: 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.

Background: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.

Recommendations: Health care professionals should adjust the dosage of cefepime in patients with creatinine clearance less than or equal to 60 mL/min. If seizures associated with cefepime therapy occur, consider discontinuing cefepime or making appropriate dosage adjustments in patients with renal impairment.

Caregivers who notice symptoms of nonconvulsive status epilepticus in a patient receiving cefepime should seek medical attention right away. Symptoms of nonconvulsive status epilepticus could include altered mental status, confusion, and decreased responsiveness.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
List: Digitalization Companies From PACK EXPO
Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.
Download Now
List: Digitalization Companies From PACK EXPO
Break out of the ordinary: see what’s new in life sciences packaging
<strong>At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us in September to experience a breakthrough for life sciences products.</strong>
REGISTER NOW & SAVE!
Break out of the ordinary: see what’s new in life sciences packaging