FDA re-warns about IV administration of nimodipine
The FDA is re-warning healthcare professionals that oral nimodipine capsules (Nimotop, Bayer HealthCare), a dihydropyridine calcium channel blocker originally developed for the treatment of high blood pressure, should be given only by mouth or through a feeding or nasogastric tube and should never be given by intravenous (IV) administration.
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. IV injection of nimodipine can result in death, cardiac arrest, severe falls in blood pressure and other heart-related complications, according to the agency.
In 2006, FDA added a boxed warning and made other revisions to the prescribing information to warn against intravenous use of nimodipine. The prescribing information also provides clear instructions on how to remove the liquid contents from the capsules for nasogastric tube administration in patients who are unable to swallow. The instructions recommend that the syringe used for withdrawal of capsule contents be labeled with "Not for IV Use."
The agency said it is continuing to receive reports of IV nimodipine use, with serious, sometimes fatal, consequences, which is the reason for the new warning.
The Drug Safety Communication provides additional information for healthcare professionals, for patients and a data summary of reported medication errors. The FDA said it will “continue working with the manufacturers of nimodipine and with outside groups to evaluate and implement additional ways to prevent medication errors with this product.”
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. IV injection of nimodipine can result in death, cardiac arrest, severe falls in blood pressure and other heart-related complications, according to the agency.
In 2006, FDA added a boxed warning and made other revisions to the prescribing information to warn against intravenous use of nimodipine. The prescribing information also provides clear instructions on how to remove the liquid contents from the capsules for nasogastric tube administration in patients who are unable to swallow. The instructions recommend that the syringe used for withdrawal of capsule contents be labeled with "Not for IV Use."
The agency said it is continuing to receive reports of IV nimodipine use, with serious, sometimes fatal, consequences, which is the reason for the new warning.
The Drug Safety Communication provides additional information for healthcare professionals, for patients and a data summary of reported medication errors. The FDA said it will “continue working with the manufacturers of nimodipine and with outside groups to evaluate and implement additional ways to prevent medication errors with this product.”