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More shocking to the former Ontario MPP, Health Canada knew of these risks: since approving Prepulsid in 1990, the agency, which approves and monitors prescription drugs through its Therapeutic Products Directorate, had sent four letters to doctors, the last in 1998, warning about serious adverse effects, including heart risks in children, women and infants. S., Young learned, Vanessa might not have been prescribed cisapride. In January 2000, two months before Vanessa died, the FDA issued an advisory alerting doctors of heart attack risks and rewrote label warnings; in April, it announced cisapride would be pulled from the market in July 2000.Health Canada followed suit that May, taking Prepulsid off the market in August.It won’t be debated until late next year, at the earliest.
She was rushed to hospital, where she died a day later. Neither their doctor or pharmacist mentioned risks; her parents considered it “super Rolaids.” But when Young dug deeper, he found cisapride was far more toxic than the heartburn it treated: it was linked to 80 deaths in Canada and the U. and had generated a total of 341 “adverse reaction” reports in the two countries. Food and Drug Administration (FDA) had given it its ominous “black box” warning, an alarm bell that makes doctors far less likely to prescribe a drug.
The study, published last month in the shows risks are higher for drugs fast-tracked in 180-day “priority reviews” (versus the 300-day norm): 34.2 per cent had serious warnings.
Clinical trial results offer a rosy, unrealistic picture of how a drug works, says Juurlink: “In the real world, we don’t monitor people as closely and we don’t select people as carefully.
And that figure is likely a gross understatement: it is extrapolated from a 14-year-old study, led by University of Toronto researchers and published in the April 1998 that found deaths linked to prescription drugs accounted for some 106,000 fatalities annually in the U.
S., making it the fourth-leading cause of death, behind cancer, heart disease and stroke.
One notorious exception was the arthritis drug Vioxx, fast-tracked in 1999 despite known risks; it was removed in 2004 amid a flood of lawsuits after at least 55,000 deaths worldwide.