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nimodipine FDA Alerts

The FDA Alert(s) below may be specifically about nimodipine or relate to a group or class of drugs which include nimodipine.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for nimodipine

Nimodipine: Recall - Crystallization of Fill Material

Sep 5, 2012

Audience: Emergency Medicine, Pharmacy, Patient

ISSUE: Sun Pharmaceutical Industries, Inc. recalled one lot of Nimodipine Capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd. Sun commenced the recall as a precautionary measure due to the presence of crystals of nimodipine within the capsule solution of this lot as identified by a customer complaint. No adverse events have been reported at this time. The crystallization of the nimodipine fill material in the capsule could adversely affect the product’s bioavailability. The product may no longer be bioequivalent and may potentially affect patients who are being treated for a medical emergency.

BACKGROUND: Nimodipine Capsules, 30 mg, are used to decrease problems due to subarachnoid hemorrhage (bleeding in the brain). The following lot numbers to the consumer level are affected:
Lot Number: 3305.039A, NDC Number: 57664-135-65 (Unit Dose Blisters of 100 (25x4))
Lot Number: 3305.039B, NDC Number: 57664-135-64 (Unit Dose Blisters of 30 (5x6))

RECOMMENDATION: Patients and healthcare providers using Nimodipine Capsules, 30 mg, with one of the above lot numbers should discontinue use of the product. Patients who have medical questions should contact their healthcare provider for additional instructions or guidance.

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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[09/04/2012 – Press Release - Sun Pharmaceutical Industries]

Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms

Aug 2, 2010

Audience: Neurosurgery, Anesthesia, Risk Manager

ISSUE: FDA reminded healthcare professionals that oral nimodipine capsules should be given only 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.

BACKGROUND: 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 continues to receive reports of intravenous nimodipine use, with serious, sometimes fatal, consequences.

RECOMMENDATIONS: The Drug Safety Communication, link below, provides additional information for Healthcare Professionals, for Patients, and a Data Summary of reported medication errors. 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.

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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/02/2010 - Drug Safety Communication - FDA]
[12/2005 - Prescribing Information - Bayer]

    

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