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Information for Healthcare
Professionals
Nimodipine (marketed as Nimotop)
The issues described in this communication have been
addressed in product labeling, please see Drugs@FDA
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FDA ALERT [1/2006): The FDA has requested that Bayer add a
boxed warning to the nimodipine (Nimotop) labeling to warn about
medication administration errors with nimodipine. Nimodipine is
approved for oral administration to improve neurological outcome after
subarachnoid hemorrhage. When administered intravenously or
parenterally, it can cause serious adverse events, including death.
Nimodipine must not be administered intravenously or by any
parenteral route.
This information reflects FDA’s
current analysis of data available to FDA concerning this drug. FDA
intends to update this sheet when additional information or analyses
become available.
To report any unexpected adverse or serious
events associated with the use of this drug, please contact the FDA
MedWatch program and complete a form on line at
http://www.fda.gov/medwatch/report/hcp.htm or report by fax to
1-800-FDA-0178, by mail using the postage-paid address form provided
on line, or by telephone to
1-800-FDA-1088.
Recommendations
Healthcare providers who prescribe, dispense or administer
Nimodipine should
- Administer nimodipine capsules orally only.
- For patients unable to swallow a capsule, use an oral syringe to
extract the gel inside the capsule. The syringe should be labeled
“for oral use only.” The nimodipine gel should be administered
through the patient’s naso-gastric tube or G-tube, followed by 30 ml
normal saline solution (0.9%).
- Ensure that nimodipine is never administered intravenously, or
by any parenteral route.
Data Summary
- The FDA has received reports of medication administration errors
in which nimodipine was given intravenously or parenterally, rather
than orally.
- In addition to a fatal case reported in 2005, there has been a
history of these errors. Two cases were reported in 1995. Another
case, which resulted in death, was reported in 1996.
Additional non-fatal cases were reported in 1999, and in 2002 (two
cases).
- After the 1996 case, the manufacturer, Bayer, included a bolded
statement in the labeling, warning against incorrect administration.
- Because cases are still occurring, FDA has asked Bayer to add a
boxed warning to the nimodipine labeling to describe the
life-threatening risk of parenteral administration. Additionally,
FDA has requested that Bayer develop an oral solution of nimodipine
for use in patients who cannot swallow a capsule.
- Nimodipine is a calcium-channel blocker, which lowers blood
pressure; when the drug is administered intravenously instead of
orally, the effect can be much stronger, leading to cardiovascular
collapse and possibly to death.
Nimotop Labeling
(approved 1/20/2006)
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Date created: January 30, 2006; Updated: July, 2007 |
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