ST LOUIS (MD Consult) - On August 2, 2010, the US Food and Drug Administration (FDA) issued a reminder to health care professionals that the oral drug nimodipine should never be administered intravenously (IV). The FDA is continuing to receive reports of IV nimodipine use, with serious, sometimes fatal, consequences. Intravenous injection of nimodipine can result in death, cardiac arrest, severe falls in blood pressure, and other heart-related complications.

Nimodipine is a medication intended to be given in a critical care setting to treat neurologic complications from subarachnoid hemorrhage and is only available as a capsule.

The FDA has identified 31 cases of medication errors associated with the use of nimodipine. Of these, 25 involved erroneous nimodipine intravenous prescribing or administration. Four of the patients who mistakenly received IV nimodipine died; 5 patients were characterized as experiencing near-death events; and 1 patient was characterized as having experienced permanent harm.

In 2006, a Boxed Warning and other revisions were made to the prescribing information for nimodipine to warn against IV use of the drug.

The nimodipine prescribing information contains specific instructions for using a needle to make a hole in both ends of the capsule to remove the liquid contents with a syringe and then empty the syringe contents into a feeding tube. Because a standard needle will not fit on an oral syringe, the needle must be attached to an IV syringe. The instructions recommend that the syringe used for withdrawal of capsule contents be labeled with the statement, "Not for IV use."

The FDA plans to continue working with the manufacturers of nimodipine and with outside groups to evaluate and implement additional ways to prevent medication errors with this product. Adverse events related to the use of nimodipine should be reported to the FDA's MedWatch Program.

圣路易斯(MD Consult)——2010年8月2日，美国食品药品管理局(FDA)提醒医护人员，口服药尼莫地平不能通过静脉(IV)给药。FDA将继续收集关于尼莫地平静脉给药导致严重(有时为致命)后果的不良反应报告。尼莫地平静脉给药会导致死亡、心脏骤停、血压急剧下降及其他心脏并发症。

 

尼莫地平是一种在重症监护环境下用于治疗蛛网膜下腔出血引发的神经并发症的药品，上市产品只有胶囊剂。

 

FDA已确定31例尼莫地平相关的错误用药病例。其中25例错误用药为静脉给予尼莫地平。其中4例错误接受静脉给药的患者死亡；5例患者濒临死亡；1例患者出现永久损伤。

 

2006年，在尼莫地平的药品处方信息中加入黑框警告及其他修订用以警告该药不能静脉给药。

 

尼莫地平处方信息中包含特定说明：用针头在胶囊两头各刺一孔，用注射器抽取液体成分，然后注入饲食管。因为标准针头与口服注射器不匹配，因此必须采用静脉注射器。该说明建议，对用来抽取胶囊中药物成分的注射器标记"非静脉注射(IV)用"字样。

 

FDA计划继续与尼莫地平生产商及外界团体协商，评估并采取新方法以预防尼莫地平错误给药。与尼莫地平使用相关的不良事件应向FDA的MedWatch Program报告。