Canadian Allergy, Asthma and Immunology Foundation

Fondation canadienne d'allergie, d'asthme et d'immunologie
caaif@rcpsc.edu

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Health Canada / CFIA Advisory

Advisory - Safety information about ElidelŪ cream and ProtopicŪ ointment

2005-31
April 27, 2005
For immediate release

Advisory
Safety information about ElidelŪ cream and ProtopicŪ ointment

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

  • Use ElidelŪ and ProtopicŪ only when other treatments have been shown to be ineffective or unsuitable.

  • Use a thin layer of ElidelŪ or ProtopicŪ to control symptoms and only for short periods of time as the long-term safety is unknown.

  • Avoid using ElidelŪ and ProtopicŪ in children younger than two years of age as the effect on the developing immune system is unknown.

  • ElidelŪ or ProtopicŪ 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 ElidelŪ and ProtopicŪ 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.

As of December 2004, the FDA had received reports of 10 cases linking ElidelŪ with cancer-related adverse events, and 19 cases linking ProtopicŪ with cancer-related adverse events. In Canada, there have been two reports of cancer-related adverse events for ElidelŪ, and no reports for ProtopicŪ.

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

ElidelŪ is made by Novartis Pharmaceuticals. ProtopicŪ is made by Fujisawa Healthcare Inc.

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

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.

Media Inquiries:
Jirina Vlk
Health Canada
(613) 957-2988

Public Inquiries:
(613) 957-2991