FDA要求警惕头孢吡肟的癫痫风险

美国食品药品管理局(FDA)报告，在肾损害患者中发生了多例与使用抗菌药物头孢吡肟相关的非惊厥性癫痫持续状态(NCSE)。

FDA指出，这种类型的癫痫主要见于未合理调整头孢吡肟剂量的肾损害患者，不过也有数例患者根据肾损害情况合理调整了头孢吡肟剂量却仍然发病。FDA目前正在修订头孢吡肟药物标签中的“警告与注意事项”和“不良反应”部分内容，以强调这一风险。

FDA建议医务人员对肌酐清除率≤60 ml/min的患者调整头孢吡肟剂量，以尽可能降低癫痫风险。如果发生了与头孢吡肟治疗相关的癫痫，临床医生应考虑停用头孢吡肟，或对肾损害患者的用药剂量作出恰当调整。

经过在FDA不良事件报告系统(AERS)数据库中检索，FDA确认从1996年至2012年2月共有59例患者发生头孢吡肟相关性NCSE。这些患者的癫痫多数是可逆的，在停用头孢吡肟和(或)血液透析后即可消失。

头孢吡肟是一种头孢菌素类抗菌药物，用于治疗肺炎、泌尿道、皮肤和腹内感染。

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The Food and Drug Administration has reported cases of a specific type of seizure called nonconvulsive status epilepticus that is associated with the use of the antibacterial drug cefepime in patients with renal impairment.

The sei zures have been seen primari ly in patients with renal impairment who did not receive appropriate dosage adjustments of cefepime, although in several cases patients received "dosage adjustment appropriate for their degree of renal impairment," according to the agency. The FDA is working to revise the "Warnings and Precautions" and "Adverse Reactions" sections of the cefepime label to highlight this risk. 

The FDA advises health care professionals to adjust the dosage of cefepime in patients with a creatinine clearance of 60 mL/min or less in order to minimize the risk of seizures. If seizures associated with cefepime therapy occur, physicians should consider discontinuing cefepime or making appropriate dosage adjustments in patients with renal impairment.

Nonconvulsive status epilepticus associated with cefepime occurred in 59 patients from 1996 through February 2012. The cases were identified through the FDA’s Adverse Event Reporting System (AERS) database. The majority of seizures were reversible, and resolved after discontinuation of cefepime and/or after hemodialysis.

Cefepime is a cephalosporin antibacterial drug used to treat pneumonia, urinary tract, skin, and intra-abdominal infections.