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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: www.fda.gov/MedWatch/report.htm
* 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
MedWatch safety alert, including a link to the Recall Notice at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
有一些使用cefepime引起nonconvulsive status epilepticus的案例已被登載於醫學文獻及FDA的不良反應通報系統。大部分案例為腎功能不佳的病人未接受適當的cefepime劑量調整，然 而，有一些案例已依腎功能調整cefepime劑量，卻仍發生該不良反應。大部分的案例在停止使用cefepime及/或洗腎後，就可緩解 seizure。目前正在修正cefepime仿單中Warnings and Precautions及Adverse Reactions部分，將特別強調此不良反應的風險。其它詳細資訊請見FDA網站上Drug Safety Communication。
建議當病人Clcr≦60 mL/min時，醫療人員應適當調整cefepime劑量，當發生seizure時，應考慮停止使用cefepime或是依腎功能調整cefepime劑 量。照護者若發現病人出現nonconvulsive status epilepticus的症狀時，如意識改變(altered mental status)、意識混亂(confusion)及反應低下(decreased responsiveness)，應立即尋求醫療人員協助。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm309822.htm
[Posted 06/26/2012]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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資料來源：藥師週刊（第1780期）