Important Safety Information on Argatroban - Notice to Hospitals

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Contact: Health Products and Food Branch Inspectorate (HPFBI)

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The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Glaxo Operations UK Limited and Shopper's Drug Mart Specialty Health Network.
Contact the company for a copy of any references, attachments or enclosures.

NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on Argatroban

November 7, 2008

To: Hospital Chief of Medical Staff

Please distribute to relevant Departments of Surgery, Emergency Medicine, Pharmacy, Paediatrics, Internal Medicine, Haematology, Cardiology, Nursing, Intensive Care and/or other Departments as required, and other involved professional staff and post this Notice in your institution.

Subject:

Recall of ARGATROBAN 100 mg/mL for injection due to the risk of infection and underdosing.

Glaxo Operations UK Limited ("GSK UK") and Shoppers Drug Mart Specialty Health Network ("SDM SHN") (formerly Calea Health Access, a Division of Calea Ltd.), in consultation with Health Canada, is writing to inform you of important safety information regarding Argatroban. GSK UK has detected a manufacturing issue, with cracks in a small percentage of individual glass vials of Argatroban distributed in Canada and the United States, that may affect the safety or effectiveness of this product. Specifically, this could potentially result in microbial contamination and/ or leakage of the affected vials which may pose a risk of infection and possible underdosing to the patient.

Two lots (C347625 and C363385) of Argatroban vials are being recalled from the Canadian market. From these two lots, only vials identified by the number 47 at the bottom of the vial (see attached photograph and drawing appear to be problematic.

In the event patients with Heparin-Induced Thrombocytopenia (HIT) require treatment before the product can be resupplied, GSK UK and SDMSHN advises the following:

Argatroban is indicated as anticoagulant therapy in patients with heparin-induced thrombocytopenia syndrome, who, in the opinion of their attending physician, require anticoagulation.

Routine manufacturing inspection has revealed cracks in the individual glass vials of Argatroban associated with a specific glass mold #47 (attached photograph and drawing). These cracked vials can leak if the vial is inverted. Although the cracks in the glass vials may not be readily apparent, testing revealed that approximately 0.1% of the total vials in Canada and the U.S. marketplace may have this defect. This could potentially result in infection and possible underdosing to patients. Currently, no other molds have revealed this manufacturing defect, and there are no quality issues with the active ingredient, Argatroban, itself.

GSK UK and SDM SHN are voluntarily recalling 2 lots of Argatroban vials (lot numbers C347625 and C363385) from the Canadian marketplace and advises that the affected lots should not be used unless medically critical as per the above boxed recommendations. GSK UK and SDM SHN are working diligently to resupply the marketplace with new product. Unused product in the hospital or clinic setting should be returned to the institution's pharmacy. Pharmacies are directed to hold onto their current supply of product until they are resupplied with the unaffected vials. It is expected that the resupply will be available from wholesalers starting November 7th 2008. New shipments received after this resupply date are not subject to this recall.

Please note that the product is marked with logos for Encysive and Calea. Argatroban is manufactured by GSK UK and distributed in Canada by Shoppers Drug Mart Specialty Health Network.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of vial leaking or any serious or unexpected adverse reactions in patients receiving Argatroban should be reported to SDM SHN or Health Canada at the following addresses:

Shopper's Drug Mart Specialty Health Network
Telephone: 1-866-201-1131

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 866-234-2345
Fax: 866-678-6789
CanadaVigilance@hc-sc.gc.ca

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

For other inquiries related to this communication, please contact Health Canada at:
Health Products and Food Branch Inspectorate (HPFBI)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Inspectorate hotline: 1-800-267-9675
Fax: 1-613-946-5636

GSK UK is working with Health Canada regarding this issue and, together with SDM SHN, we expect to have a supply of unaffected Argatroban vials to Canadian wholesalers from November 7th.

Sincerely,

original signed by

Glaxo Operations UK Limited

Dr. Jai Patel, BSc, MRCP
Medicines Development Center

Shoppers Drug Mart Specialty Health Network

Eva Morris BSc
Quality Assurance Manager

VIEW ON UNDERSIDE OF VIAL