Contamination at drug plant could affect global supplies of bladder cancer drug

TORONTO – Health Canada is warning that a contamination problem at a manufacturing plant in Toronto could affect global supplies of a bladder cancer drug.

The agency says it conducted an inspection which found mould in what is supposed to be a sterile manufacturing area of Sanofi Pasteur’s plant where the drug, ImmuCyst, is made.

Health Canada says it has concluded ImmuCyst should remain on the market, as long as it meets quality assurance standards.

Samples from each lot of the drug will be evaluated by both Sanofi and Health Canada before it can be shipped to market.

Health Canada says it has asked Sanofi to advise Canadian doctors of the situation and suggests patients who have concerns about the medication should speak with their health-care provider.

A spokesperson for Sanofi Pasteur was not immediately available for comment.

Last month Health Canada announced that Sanofi was recalling tuberculosis vaccine made in the same plant because of concerns the product might be contaminated.

While there is another bladder cancer drug available in Canada, Sanofi makes the only TB vaccine currently licensed for use in this country. The Public Health Agency of Canada is currently trying to find an alternative source of TB vaccine.

The two products are made in the same building at Sanofi’s Toronto facility. The building was flooded last October and the company has had ongoing production challenges related to the flood.

Health Canada says it will consult with international regulatory counterparts about the ImmuCyst situation and is working with the company to expedite a resolution of the problems at the plant.