Archived - Omniscan (Gadodiamide) Injection - Advisories, Warnings and Recalls for Health Professionals

Starting date:

July 12, 2006

Posting date:

July 17, 2006

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001425

This is duplicated text of a letter from GE Healthcare Canada Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Omniscan (gadodiamide) injection

2006-07-12

Dear Health Care Professional,

Subject: Association of Nephrogenic Systemic Fibrosis /Nephrogenic Fibrosing Dermopathy (NSF/NFD) with the use of gadolinium (Omniscan™)

GE Healthcare has recently received 25 cases, originating in two hospitals (Austria and Denmark), of NSF/NFD following administration of Omniscan Injection a gadolinium-based imaging agent for magnetic resonance angiography (MRA), an unlabeled indication in Canada. The cases were reported over a period of four years. Of these cases, 15 were serious in nature, involving disability with or without hospitalization, and 10 were non-serious with mild symptoms. Based on current evidence, a causal relationship between gadolinium exposure and NSF/NFD has not been established.

Description of NSF/NFD

Patients with NSF/NFD describe swelling and tightening of the skin, usually limited to the extremities. The condition may develop over a period of days to several weeks. In many cases, the skin thickening inhibits the flexion and extension of joints, resulting in contractures. Some patients with NSF/NFD (estimated at 5% or less) have an exceedingly rapid and fulminant disease course. NSF/NFD may contribute to death by restricting effective ventilation, or by restricting mobility to the point of causing a fall. NSF/NFD appears to occur in patients with kidney failure along with metabolic acidosis. To date there is no evidence that NSF/NFD is caused by a medication, a microorganism, or by dialysis.

• To date, GE Healthcare has received 25 cases of NSF/NFD following administration of Omniscan a gadolinium-based imaging agent when used for magnetic resonance angiography (MRA). All patients had severely impaired renal function (Glomerular Filtration Rate ≤15 cc/min) with the majority receiving regular dialysis, before Omniscan administration. Based on current evidence, a causal relationship between gadolinium exposure and NSF/NFD has not been established.
• NSF/NFD is a rare, rapidly developing, mild to disabling condition that can be fatal in rare cases, and that has been reported to date only in patients with severely impaired renal function.
• Omniscan is not approved for MRA in Canada.
• GE Healthcare is working with the reporting hospitals, medical experts, and world-wide regulatory authorities, to further investigate this issue.

Risk management measures

There is no evidence that patients without severe renal impairment are at risk of developing NSF/NFD, therefore no special restrictions or instructions are required except in this group.

GE Healthcare received no reports of NSF/NFD in patients with renal impairment who received doses within prescribing information recommendations. Current prescribing information recommends caution when using Omniscan in patients with renal impairment. Healthcare providers should consider alternatives to gadolinium-enhanced MRA in patients with severe renal impairment.

Adverse event reporting

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 serious NSF/NFD or other serious or unexpected adverse reactions should be reported to the appropriate manufacturer or Health Canada. Serious or unexpected adverse events in patients receiving Omniscan should be reported to GE Healthcare or Health Canada at the following addresses:

GE Healthcare Canada Inc.

2300 Meadowvale Blvd

Mississauga, Ontario, L5N 5P9

Tel: 1-800-367-2773 or Fax: (905) 847-5849

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: (613) 957-0337 or Fax: (613) 957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:

Tel: 866 234-2345

Fax: 866 678-6789

cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR 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

Tel: (613) 954-6522

Fax: (613) 952-7738

Sincerely,

original signed by

J. Sardi

General Manager

GE Healthcare Canada