Cisapride: new restrictions

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Editor, – In view of the safety concerns about cisapride, the Pharmaceutical Benefits Advisory Committee has considered details of the use of the drug in Australia. This included a summary of the situation overseas in relation to the incidence of cardiac arrhythmias or sudden cardiac arrest associated with cisapride.

The Committee recommended that the current Pharmaceutical Benefits Scheme restricted benefit listing for gastroparesis and reflux oesophagitis be amended to an authority required listing for the treatment of gastroparesis where the diagnosis has been made or confirmed by a consultant physician. In addition, the Committee recommended that the caution: 'Cisapride may cause serious cardiac arrhythmias' be added to the amended listing. This amendment is to be implemented in the November 2000 Schedule of Pharmaceutical Benefits. A 'Dear Doctor' letter of explanation will also be included in this edition of the schedule.

The Committee considered that cisapride only has a role in the treatment of gastroparesis. Members were of the view that it is inferior to the proton pump inhibitors in the treatment of reflux oesophagitis.

The Therapeutic Goods Administration has restricted the approved indication for cisapride in reflux oesophagitis to patients with severe disease who have not responded to a proton pump inhibitor. There are, however, no data to show that cisapride is cost-effective for this indication.

Although the dosage of cisapride recommended in Australia differs from the product information in the USA, no evidence was provided by the sponsor to show that lower doses are used in Australia.

Diana MacDonell
Pharmaceutical Benefits Advisory Committee