Mr. Speaker, Health Canada’s Canada vigilance program collects and assesses reports of suspected adverse reactions, or ARs, to health products marketed in Canada. Adverse reactions are undesirable responses to health products. Health Canada defines a serious adverse reaction as: “A noxious and unintended response to a drug, which occurs at any dose and requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above, may also be considered serious.”
Adverse reaction reports are submitted by health professionals and consumers either directly to Health Canada or via market authorization holders--i.e., manufacturers. Manufacturers must report all domestic serious AR reports to Health Canada as per regulatory requirements.
From January 1, 2010, to December 31, 2017, the Canada vigilance program received a total of 345,189 domestic AR reports. This number does not include follow-up reports. This includes 1,605 reports in which the suspect product was Fluorouracil, 5-FU. Of these 1,605 reports, 1,572 were deemed to be serious by the reporter.
Caveats are as follows: There may be AR reports that have been received from multiple sources representing the same case. For example, a report may be submitted by both a patient and a health care professional but represent the same case. This means that there may be fewer cases than the total of 345,189 AR reports. This also means that there may be fewer cases for Fluorouracil, 5-FU, as the suspect product.
The number of reports received should not be used as a basis for determining the incidence of a reaction, as neither the total number of reactions occurring nor the number of patients exposed to the health product is known.
Often it is not possible to determine if an AR reported to Health Canada is a result of using a specific health product. Other factors contributing to the AR could be a person's health conditions or other health products they are using at the same time.