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OPTIMARK (gadoversetamide injection) – Association with Nephrogenic Systemic Fibrosis (NSF) in Patients with Renal Impairment - For Health Professionals
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(PDF Version - 103 K)Contact: Marketed Health Products Directorate (MHPD)
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This is duplicated text of a letter from Tyco Healthcare (Covidien).
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on OPTIMARK
January 8, 2010
Subject: New safety information on OPTIMARK (gadoversetamide injection) associated with Nephrogenic Systemic Fibrosis (NSF) in patients with renal impairment
Dear Health Care Professional,
Tyco Healthcare/Covidien in consultation with Health Canada, would like to inform you of important new safety information regarding Optimark® (gadoversetamide), a gadolinium (Gd)-based contrast agent (GBCA) used to enhance the contrast of magnetic resonance images.
Tyco Healthcare/Covidien continues to receive post-market reports of NSF associated with Optimark® in some renally-impaired patients. From August 15, 2006 to October 15, 2009, a total of 93 reports of NSF have been reported worldwide associated with the use of Optimark®. It is estimated that 5 134 252 vials of Optimark were distributed worldwide from August 1, 2006 to October 31, 2009. There are no cases of NSF associated with Optimark® in Canada at this time. Tyco Healthcare/Covidien has submitted additional product labeling changes to Health Canada.
- Optimark® will now be contraindicated in patients with 1) acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or 2) acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
- Optimark® is not recommended for use in children below the age of two years because the safety and efficacy of gadoversetamide, as well as impact of use in patients with an immature kidney function have not been studied.
For more information about Optimark®, please refer to the Canadian Product Monograph that provides current full prescribing information. A copy of the most up-to-date Canadian Product Monograph for Optimark® can be found on the Health Canada Web site.
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 case of serious Nephrogenic Systemic Fibrosis (NSF) or other serious or unexpected adverse reactions in patients receiving Optimark should be reported to Tyco Healthcare/Covidien or Health Canada at the following addresses:
7300 Trans-Canada
Pointe-Claire, Quebec
H9R 1C7
Telephone: 1-514-695-1220
Telephone: 1-877-664-8926
Fax: 1-514-695-2379
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
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789
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:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738
Sincerely,
original signed by
Joseph Di Marzo
Director, Regulatory Affairs and Quality Assurance
