Postmarket Drug Safety Information for Patients and Providers > FDA Drug Safety Communication: Serious medication errors from intravenous administration of nimodipine oral capsules

FDA Drug Safety Communication: Serious medication errors from intravenous administration of nimodipine oral capsules

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary

Safety Announcement
[08-02-2010] The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals that nimodipine capsules should be given ONLY by mouth or through a feeding tube (nasogastric tube). This oral medication should NEVER be given by intravenous administration. FDA continues to receive reports of intravenous 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 (ruptured blood vessels in the brain) and is only available as a capsule.

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."

FDA 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.



Additional Information for Patients
FDA encourages all patients to talk to their healthcare professional if they have concerns about any treatment they are receiving.
Report any side effects from the use of medication to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

open here to see the full-text:
Postmarket Drug Safety Information for Patients and Providers > FDA Drug Safety Communication: Serious medication errors from intravenous administration of nimodipine oral capsules