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Safety Information About Elidel Cream and Protopic Ointment

Apr 27, 2005 | Health Canada

Health Canada is advising people who use Elidel cream and Protopic 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 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.

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

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 Fujisawa Healthcare Inc.

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