Archive– Safety Information about Elidel Cream and Protopic Ointment

Starting date:

April 27, 2005

Posting date:

April 27, 2005

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety, Product label update

Audience:

Healthcare Professionals, General Public

Identification number:

RA-11000569

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  Media enquiries
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  Public enquiries

Health Canada is advising people who use Elidel® cream and Protopic® ointment about safety information that indicates a potential cancer risk. Health Canada is recommending that people using these prescription products, which are approved for the treatment of eczema in adults and children two years and older, follow the approved directions for use and consider the following:

• Use Elidel® and Protopic® only when other treatments have been shown to be ineffective or unsuitable.
• Use a thin layer of Elidel® or Protopic® to control symptoms and only for short periods of time as the long-term safety is unknown.
• Avoid using Elidel® and Protopic® in children younger than two years of age as the effect on the developing immune system is unknown.
• Elidel® or Protopic® should not be used in children and adults with weakened immune systems.
• Patients are advised to consult their physician should they have any concerns.

In March 2005, the United States Food and Drug Administration (US FDA) posted a Public Health Advisory and Alerts for Healthcare Professionals on its website, informing people about a potential cancer risk from the use of Elidel® and Protopic® products when applied to the skin to treat eczema. The US advisory followed recommendations made by the FDA's Pediatric Advisory Committee meeting of February 15, 2005 and is based on information from animal studies, case studies, case reports in a small number of patients, and other knowledge of how these drugs work.

Health Canada will require labelling changes for Elidel® and Protopic®, including updates to safety information about the potential cancer risk.

Elidel® is made by Novartis Pharmaceuticals. Protopic® is made by Astellas Pharma Canada, Inc. (formerly Fujisawa Canada, Inc). Fujisawa Healthcare Inc.

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Telephone: 613-957-0337

Facsimile: 613-957-0335

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

Telephone: 1-866-234-2345

Facsimile: 1-866-678-6789

cadrmp@hc-sc.gc.ca

For other inquiries: please refer to contact information.

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.

• Report of Suspected Adverse Reaction due to Health Products Marketed in Canada (Vaccines excluded)
• Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Guidelines for the Voluntary Reporting of Suspected Adverse Reactions to Health Products by Health Professionals and Consumers

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709