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Health professional risk communication

Zeftera (ceftobiprole medocaril) for Injection - Discontinuation of Sale - Notice to Hospitals

Starting date:
April 9, 2010
Posting date:
April 9, 2010
Type of communication:
Notice to Hospitals
Subcategory:
Drugs
Source of recall:
Health Canada
Audience:
Healthcare Professionals
Identification number:
RA-170002394

This is duplicated text of a letter from Janssen-Ortho Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Endorsed Important Safety Information on ZEFTERA (ceftobiprole medocaril) for Injection

April 9, 2010

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Surgery, Medicine, Intensive Care, Anesthesiology, Emergency, Nursing, Pharmacy, Laboratory Services, and other involved professional staff and post this NOTICE in your institution.

Subject: Discontinuation of Sale of ZEFTERA Footnote* (ceftobiprole medocaril) for Injection

Janssen-Ortho is discontinuing sale of ZEFTERA (ceftobiprole medocaril) for Injection effective April 16th, 2010.

ZEFTERA is currently approved for the treatment of complicated skin and skin structure infections including non-limb-threatening diabetic foot infections without concomitant osteomyelitis caused by Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Staphylococcus aureus (including methicillin-resistant isolates) and Streptococcus pyogenes.

This action is being taken by Janssen-Ortho following discussions with Health Canada in response to recent regulatory recommendations in the United States and European Union to not approve ZEFTERA for this indication due to concerns regarding the conduct of clinical trials.

Consistent with the decision to discontinue sale of ZEFTERA, Janssen-Ortho is asking Canadian distributors to return any product remaining in their inventories after April 16th, 2010. Further directions on how to handle product returns will be communicated to distributors in the next few business days.

Advice to Health Care Professionals:

Prescribers are advised:

  • To allow all patients on the product to complete their course of therapy
  • Not to initiate treatment of new patients

The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse drug reaction reporting programs. Any occurrences of serious and/or unexpected adverse reactions in patients receiving ZEFTERA should be reported to Janssen-Ortho Inc. or the Marketed Health Products Directorate at the following addresses:

Drug Safety Department
Janssen-Ortho Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Or call toll free at 1-800-567-3331
Or email to dsscan@joica.jnj.com
Or fax to 416-449-2658

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701D
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
CanadaVigilance@hc-sc.gc.ca

To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789

Postage paid labels, the Canada Vigilance Reporting Forms and the Adverse Reaction Reporting Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Health Canada asks that you share these recommendations with your staff or membership and encourage their implementation.

Should you have any questions or require additional information, please contact Janssen-Ortho Inc. Medical Information Department at 1-800-567-3331 from 9:00 am to 5:00 pm Monday to Friday Eastern Standard Time (EST) or by Facsimile at 416-449-2658.

Sincerely,

original signed by

Cathy Lau, PhD.
Vice President
Regulatory and Quality

Footnote *

All trademark rights used under license.

Return to footnote * referrer