FDA Warns of Nimodipine Medication Errors

The U.S. Food and Drug Administration (FDA) just issued a warning reminding healthcare professionals that <"http://www.yourlawyer.com/practice_areas/defective_drugs">Nimodipine Oral Capsules should only be given by mouth or through a feeding or nasogastric tube and should never be given by intravenous administration.

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. Intravenous injection of nimodipine can result in death, cardiac arrest, severe falls in blood pressure, and other heart-related complications.

In 2006, the 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 FDA continues to receive reports of intravenous nimodipine use, with serious, sometimes fatal, consequences.

The Drug Safety Communication, which can be accessed at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220386.htm provides additional information for Healthcare Professionals and for Patients, and also includes a Data Summary of reported medication errors.

The FDA wrote that it will continue working with the manufacturers of nimodipine and with outside groups to evaluate and implement additional ways in which to prevent medication errors with this product.

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 by either completing and submitting the report online at www.fda.gov/MedWatch/report.htm; downloading the form and returning it to the address on the pre-addressed form, calling 1-800-332-1088 to request a reporting form, submitting the form by fax to1-800-FDA-0178.

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