Advisory - Safety
information about ElidelŪ cream and ProtopicŪ ointment
April 27, 2005
For immediate release
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
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
For other inquiries: please refer to
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.