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Archived – Important Safety Information regarding Refludan® – Berlex Canada Inc.
- Starting date:
- October 30, 2002
- Posting date:
- October 30, 2002
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Biologic/vaccine
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- Healthcare Professionals
- Identification number:
- RA-17000385
This is duplicated text of a letter from Berlex Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
Notice about Health Canada advisories
Important Safety Information Regarding Refludan®
October 30, 2002
Dear Health Care Professional(s),
The purpose of this communication is to inform you of clinically important safety information regarding Refludan® [lepirudin (rDNA) for injection]
Refludan® is indicated for anticoagulation in adult patients with acute coronary syndromes (ACS); i.e. unstable angina/acute myocardial infarction without ST elevation. In patients with ACS, Refludan® is intended for use with ASA. Refludan® is also indicated for anticoagulation in patients with heparin induced thrombocytopenia (HIT) and associated thromboembolic disease in order to prevent further thromboembolic complications.
The following safety information reflects recent post-marketing experience with the product:
Cases of allergic and hypersensitivity reactions, including anaphylaxis, have been reported during initial administration or upon second or subsequent exposure. In rare instances, shock and death have been reported.
Rare cases of intracranial bleeding in the absence of concomitant thrombolytic therapy have been reported following Refludan administration.
Berlex Canada Inc is committed to providing you with the most current product safety information on its products and routinely assesses safety information and updates Product Monographs accordingly. Revised prescribing information will be distributed once approved by Health Canada. We hope this information will be helpful to you in caring for your patients on Refludan®. Please consult the official Refludan Product Monograph for complete prescribing information.
The identification, characterization, and management of drug-related adverse events are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Health care professionals are asked to report any suspected adverse reactions in patients receiving Refludan®
directly to Berlex Canada Inc. at the following address:
Berlex Canada Inc.
2260 32nd Ave.
Lachine, Quebec
H8T 3H4
Tel: (800) 361-0240 or by fax at (514) 631-4721
If you have any questions regarding Refludan®, please contact Berlex Canada at (800) 361-0240.
Sincerely,
original signed by
Dr. François Charette
Vice-President, ScientificAffairs
Berlex Canada Inc.
2260, 32e Avenue, Lachine (Québec) H8T 3H4
Tél : (514) 631-7400 Fax : (514) 636-9177 www.berlex.ca
Any suspected adverse reaction to vaccines can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
Health Canada
Address Locator: 0201C2
Ottawa, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
The ADR Reporting Form and the ADR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.