Health Canada suspends Ont. facility that produces drug for lung, breast cancers
A syringe is seen in this undated file photo. (AP / Donovan Quintero)
Published Friday, May 9, 2014 9:06PM EDT
Health Canada has ordered an Ontario pharmaceutical facility to stop selling an injectable drug used in the treatment of lung and breast cancers because of “significant concerns” with their manufacturing process.
The agency said Friday it had suspended the establishment licence of Biolyse Pharma Corporation facility in St. Catharines, Ont.
The facility is not permitted to sell paclitaxel to the Canadian market until “the serious manufacturing concerns are fully addressed and the suspension on their establishment licence is lifted,” Health Canada said.
Paclitaxel is the only drug produced at the facility.
“In the short term, Health Canada is allowing the Biolyse product currently on the market to continue to be used for treatment,” the statement said. “However, Health Canada cannot be assured that future supplies of paclitaxel from Biolyse would be safe and effective for use by patients until the serious manufacturing violations are resolved.”
Patients currently receiving paclitaxel from Biolyse are being urged to speak with a healthcare professional if they have concerns with their treatment.
Health Canada did not provide details on the concerns flagged at the facility, but said they were discovered during a recent inspection.
“To receive and maintain an establishment licence in Canada, a company must comply with Good Manufacturing Practices (GMP), which help to ensure that the drugs sold in Canada are safe, effective and of high quality,” the statement said. “These guidelines are applied to all companies and are widely known.”
Health Canada says that supplies of paclitaxel are available from another manufacturer that is licensed to produce it in Canada, and that there has been no supply disruption caused by the suspension.