FDA Again Warns Against IV Administration of Nimodipine


August 02, 2010

August 2, 2010 — As if a "black box" warning currently on the label were not enough to get anyone's attention, today the US Food and Drug Administration (FDA) again reminded clinicians that nimodipine (Nimotop; Bayer Pharmaceuticals) should be given only by mouth or through a feeding tube and never by intravenous (IV) administration, a method that could be fatal.

Nimodipine, available only as an oral capsule, is used in critical-care settings to treat neurologic complications from subarachnoid hemorrhage.

The FDA states that it continues to receive reports of IV administration of the drug, which sometimes has resulted in death or near-death events. Intravenous administration of nimodipine can cause cardiac arrest, dramatic drops in blood pressure, and other cardiovascular adverse events, according to the agency.

In 1996, Bayer added a bolded statement to the drug's label to warn against incorrect administration after 1 patient who received nimodipine the wrong way died. In 2006, the company added a boxed warning against giving nimodipine intravenously or by other parenteral routes.

Through its Adverse Event Reporting System (AERS) and other sources, including published literature, the FDA has identified 31 cases of nimodipine errors between 1989 and 2009, with 25 involving the prescription or administration of the drug intravenously. Four patients who received nimodipine intravenously died while another 5 came close. One patient suffered permanent harm, according to the agency.

Errors Sometimes Occur With Patients Who Cannot Swallow Capsule

Sometimes nimodipine is administered intravenously despite repeated warnings to the contrary when a patient is not able to swallow the capsule. Such patients are supposed to receive it through a nasogastric tube. The drug comes with instructions for making a hole in both ends of the capsule with a standard 18 gauge needle, removing the contents with a syringe, and emptying the syringe into the tube.

The agency noted that because a standard needle will not fit on an oral syringe, it must be attached to an intravenous syringe. "The use of intravenous syringes to deliver nimodipine increases the chance that the medication will be given intravenously instead of by mouth or nasogastric tube," the FDA stated.

Clinicians can minimize confusion in these circumstances by labeling the syringe with the words "Not for IV Use" and removing the needle, according to the agency. They then should empty the syringe contents into the nasogastric tube followed by 30 mL of normal saline.

More information about today's announcement is available on the FDA's Web site.

To report adverse events related to nimodipine capsules, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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