A Toronto Star investigation has revealed the fact that federal health regulator Health Canada was hiding crucial information regarding serious, sometimes fatal side-effects that may have been caused by drug prescriptions.
These side-effects are suspected to have been caused by unapproved “off-label” drug prescriptions. Off-label drug prescriptions are when pharmaceutical-grade drugs are used for a condition or age group for which it has not been approved. The said off-label drug side-effects included reports of deaths, heart attacks, strokes, birth defects and organ failures.
Health Canada blamed technical limitations for preventing the public release of information. A spokesperson, in a statement to the Toronto Star, said that the regulator is upgrading its systems.
Medical doctors across Canada and the rest of the world are routinely giving powerful drugs to vulnerable patients. Often this is done without strong scientific evidence that the drugs will be safe or effective. Sometimes this is done despite warnings that such prescribing could cause serious harm.
The Toronto Star investigation also found Health Canada is not even reviewing all the disturbing data it collects. In an analysis of a United States public database, the Star found at least 20 cases of Canadian women who delivered babies with birth defects after they were given off-label prescriptions for the anti-nausea drug ondansetron used to treat severe morning sickness. Health Canada also had similar reports but did not do any reviews of these cases.