Information Update – Sanofi Toronto Facility Update Regarding ImmuCyst
OTTAWA, July 11, 2012 /CNW/ – Health Canada has completed a thorough
health risk assessment of the bladder cancer treatment ImmuCyst
produced at Sanofi Pasteur’s manufacturing plant in Toronto.
A Health Canada inspection of Building 86 at Sanofi Pasteur’s
manufacturing plant in Toronto found the presence of mould in the
sterile manufacturing areas where ImmuCyst was produced.
Health Canada’s review has concluded that ImmuCyst should remain
available to bladder cancer patients, provided the drug continues to
meet quality assurance standards. Samples from every lot of ImmuCyst
will be evaluated for quality by both the manufacturer and Health
Canada before being released for use by Canadians. Lots that are
determined to meet specific standards will be made available as
required. At this time, the information needed from Sanofi to complete
the evaluation process for unreleased lots of ImmuCyst has not yet been
provided to the Department.
Health Canada has also requested that Sanofi communicate directly with
Canadian health care practitioners as soon as possible, to advise them
of the situation.
Patients taking ImmuCyst should speak with their health care provider if
they have concerns about the product. There is an authorized
alternative available in Canada that treats bladder cancer.
Health Canada has already worked with Sanofi regarding its voluntary recall from the Canadian market of all Bacille Calmette-GuÃ©rin (BCG)
tuberculosis vaccine produced in the same building at its Toronto facility. The Public
Health Agency of Canada is taking steps to secure an alternate supply
of this vaccine.
In light of the manufacturing problems at the Toronto plant, there may
be a global impact on the supply of ImmuCyst. Health Canada will
continue to consult with its international regulatory counterparts,
including the U.S. Food and Drug Administration.
In Canada, the safe use of health products is a responsibility shared
among a number of parties, including Health Canada as the regulator
that reviews and monitors the safety and efficacy of products, the
manufacturers that make them, physicians who prescribe them, and
informed consumers. To this end, Health Canada is working with Sanofi
to expedite its action plan to correct manufacturing problems at its
facilities to lessen the impact on patients globally.
Consumers requiring more information about this advisory can contact
Health Canada’s public enquiries line at (613) 957-2991, or toll free
SOURCE Health Canada