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Cisapride should be withdrawn from the market

Indicated for gastro-oesophageal reflux in young children, cisapride has serious adverse effects. French health authorities are being irresponsible in not completely withdrawing this drug from the market.

In 2004, the firm Janssen-Cilag announced the worldwide withdrawal of cisapride, a neuroleptic used to treat gastro-enterological disorders and under scrutiny for more than 10 years as a cause of serious cardiac arrhythmia.

In France, the sale of tablets and the drinkable solution for adults was halted on 31 December 2004. But the drinkable solution is still being sold for gastro-oesophageal reflux in some children under the age of 3, on prescription from a hospital consultant.

Cisapride has been completely withdrawn from the market in several countries, notably the USA. In 2002, the European Medicines Agency requested that a study be carried out on the cardiovascular risks associated with cisapride; it also asked the company to conduct additional clinical trials. At the end of 2007, the pharmacovigilance reports have still not been published, and the trials have not taken place.

This situation is unacceptable. Why allow more infants to be exposed to the risk of the serious, sometimes fatal, adverse effects of cisapride when other, less dangerous treatments are available? Why not publish the pharmacovigilance data? Why not insist that the trials be carried out as requested?

©Prescrire November 2007

Source: "Cisapride : toujours là… hélas !" Rev Prescrire 2007 ; 27 (289) : 816

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