Adr Highlights From 2000

The 2000 drug safety arena was notable for the large number of labelling changes and regulatory actions that resulted from safety concerns. Investigations into the association between antiretroviral drugs and metabolic disorders continued. After receiving a lot of bad press in previous years, the news on vaccines in 2000 was more positive.

In 2000, two drugs that have been on the market for many years, cisapride and phenylpropanola-mine, were withdrawn in some markets due to concern over adverse reactions. Action was taken with cisapride because of continued reports of heart disorders and deaths associated with this agent, and with phenylpropanolamine after this drug was linked to stroke in a US study.


Since cisapride ("Propulsid") was approved in the United States in 1993, labelling has been strengthened several times because of reports of heart rhythm disorders and deaths. In January 2000, the US FDA again strengthened the labelled warnings for cisapride because of continued reports of heart disorders and deaths, particularly in patients taking certain concomitant drugs or in patients with underlying risk factors.786:2 Up to 31 December 1999, cisapride had been associated with 341 reports of heart rhythm abnormalities, including 80 deaths. In March, Janssen announced that it would stop marketing cisapride in the United States in July.795:2 However, cisapride will remain available for certain US patients through a limited access programme.

In June, Health Canada requested that Jans-sen-Ortho withdraw cisapride ("Prepulsid") in Canada after receiving 44 reports of potential heart rhythm abnormalities, including 10 deaths in patients receiving the agent; pharmacy sales of the product were stopped in Canada in August.807:2 However, cisapride remains available through Health Canada's Special Access Programme for patients who do not respond to alternative therapies for gastro-oesophageal reflux. Also in June, the German regulatory authority announced that it intended to suspend the marketing of two cisapride products, "Propulsin" and "Alimix" in Germany.810:2

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