Health Canada to act on "slow" drug alerts

Health Canada has said it will take steps to speed the provision ofpublic warnings over serious side effects associated with prescription drug use. This follows criticism of the agency from the Canadian Medical Association Journal relating to the death of a 15-year-old Canadian girl who had been taking Johnson & Johnson's gastroesophageal drug Propulsid (cisapride)

J&J implemented a limited-access program for Propulsid last year after the drug was linked to fatalities and evidence that it caused heart rhythm disorders (Marketletter April 3, 2000). However, the girl's pharmacist told her inquest that he was unaware of the problems associated with Propulsid, adding that its accompanying patient information leaflet had made no mention of a link to cardiac arrhythmias.

Currently, pharmaceutical companies cannot issue PILs unless they are approved by Health Canada, but the agency is unable to guarantee that the PIL will then be provided with the drug because Canadian pharmacies come under provincial control. Also, the reporting of adverse drug reactions, including deaths, is voluntary.