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OPTIMARK (gadoversetamide injection) - Association with Nephrogenic Systemic Fibrosis (NSF) in Patients with Renal Impairment - For the Public
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(PDF Version - 101 K)Contact: Marketed Health Products Directorate (MHPD)
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 Tyco Healthcare (Covidien).
Contact the company for a copy of any references, attachments or enclosures.
Public Communication
Health Canada Endorsed Important Safety Information on OPTIMARK
January 12, 2010
Subject: Association of OPTIMARK® (gadoversetamide injection) with Nephrogenic Systemic Fibrosis (NSF)
Tyco Healthcare/Covidien in consultation with Health Canada, wishes to highlight important safety information pertaining to gadoversetamide (Optimark®), a gadolinium-based contrast agent used during magnetic resonance imaging (MRI). MRI is a test that uses a magnetic field and pulses of radio wave energy to make pictures of organs in order to detect the presence of disease.
Tyco Healthcare/Covidien continues to receive post-market reports of NSF associated with Optimark®. NSF is a rare condition which has only been observed so far in patients with kidney disease. From August 15, 2006 to October 15, 2009, a total of 93 reports of NSF have been reported as associated with the use of Optimark® worldwide. There are no cases of NSF reported with Optimark® in Canada at this time.
- Optimark® will now be contraindicated in patients with 1) severe short-term or long-term kidney problems or 2) a short-term kidney problem of any severity due to the hepato-renal (liver-kidney) syndrome or in the time period around liver transplantation.
- Optimark® is not recommended for use in children below the age of two years because the safety and efficacy of Optimark®, as well as impact of use in patients with an immature kidney function have not been studied.
This advisory and letters issued to health care professionals can be accessed on Health Canada's Web site. Tyco Healthcare/Covidien has provided this information to relevant health care professionals across Canada.
For more information about Optimark®, patients should consult their health care professional or refer to the Canadian Product Monograph that provides current full prescribing information for Optimark®. 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. 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: 1-877-664-8926
Telephone: 1-514-695-1220
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
