Important Safety Information on Inappropriate Administration of Nimotop (Nimodipine) Capsules - Notice to hospitals - Bayer Inc.

Notice to Hospitals - Health Canada Endorsed Important Safety Information on
Inappropriate Administration of Nimotop (Nimodipine) Capsules

September 21, 2005

To: Hospital Chief of Medical Staff/Director Extended Care Facilities/Director Nursing Homes

Please distribute to the relevant Departments of Neurology, Surgery, Emergency Medicine, Intensive Care, Nursing and other involved professional staff and POST THIS NOTICE in your institution.

Subject: Inappropriate Intravenous (IV) Administration of the Contents of Nimotop® (Nimodipine capsules) Oral Capsules Temporally Associated with Serious and Life-threatening Adverse Events

The Pharmaceuticals Division of Bayer HealthCare in Canada, in collaboration with Health Canada, is alerting health care professionals that inappropriate IV administration of the contents of Nimotop^® (Nimodipine capsules) 30 mg oral capsules has been reported to be temporally associated with serious, life-threatening or fatal adverse events.

Administration of Nimotop® Must Not be by Way of Injection of the Capsule Contents into an IV Line or by Other Parenteral Routes, as Temporally Associated Serious, Life-threatening and Fatal Adverse Events Have Been Reported

Medications formulated and approved for oral use that are inappropriately administered intravenously may lead to unpredictable, serious, potentially life-threatening or fatal consequences.

Nimotop^® is a calcium channel-blocking agent indicated for use as adjunctive therapy to improve the neurological outcome following subarachnoid hemorrhage (SAH) from ruptured intracranial aneurysm and is safe when administered as directed in the Product Monograph.

Nimotop^® is approved for oral use in the form of ivory-colored, soft gelatin capsules for subarachnoid hemorrhage. Each liquid-filled capsule contains 30 mg of nimodipine in a vehicle of glycerin, peppermint oil, and polyethylene glycol 400.

If the capsule cannot be swallowed, for example, at the time of surgery, or if the patient is unconscious, a hole should be made in both ends of the capsule with an 18-gauge needle and the contents of the capsule extracted into a syringe. The contents should then be emptied into the patient's in situ naso-gastric tube and washed down the tube with 30 mL of normal saline (0.9%).

Bayer is working closely with Health Canada to update the product monograph concerning the administration of Nimotop^®.

Any questions from health care professionals may be directed to Bayer Medical Information at 1-800-265-7382.

Bayer Inc.
77 Belfield Road
Toronto, Ontario
M9W 1G6
Tel.: 1-800-265-7382

Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
E-mail: cadrmp@hc-sc.gc.ca

For other inquiries, please refer to contact information:
Bureau of Cardiology, Allergy and Neurological Sciences
E-mail: bcans_enquiries@hc-sc.gc.ca
Tel.: (613) 941-1499
Fax: (613) 941-1668

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

Sincerely,

original signed by

Manoj Saxena, Ph.D. Director, Regulatory Affairs

Thomas P. Segerson, M.D. Vice President, Medical and Scientific Affairs