The Medicines Control Agency (MCA) today announced the suspension of product licences for cisapride (Prepulsid - Janssen Cilag) with its consequent withdrawal effective from 28 July 2000.
Cisapride (Prepulsid) is used to treat gastric and digestion disorders including acid reflux. The action by the MCA follows a review by the Committee on Safety of Medicines (CSM) of reports of rare, but serious, heart rhythm disturbances, associated with use of cisapride.
Patients currently taking the drug should stop taking it and see their doctor over the next few weeks to discuss their treatment. Stopping cisapride does not carry any risk. Health professionals have been informed of the withdrawal of cisapride and the need to review the management of patients currently taking the drug. Any patients seeking information before they see their doctor can contact NHS Direct (0845 4647), the nurse-led telephone advice line, or a helpline set up by Janssen-Cilag (0800 1697681).
Since 1988 when cisapride was authorised in the UK, the Yellow card scheme has received 60 reports from the UK of serious cardiovascular reactions, five of which were fatal. World-wide there have been 386 reports of serious ventricular arrhythmias (125 of these were fatal) suspected to be due to cisapride therapy, and 50 reports of sudden unexpected death. Risk factors predisposing a patient taking cisapride to heart rhythm disturbances - such as interacting medicines - can be identified in many cases, but not all cases.
Concern about cardiac arrhythmias has recently led to a Europe-wide review of the risks and benefits of cisapride. This review will be considering what indications for cisapride, if any, are justified and should be completed by 2001. The suspension of UK licences will be reassessed once the review has been completed.
Professor Alasdair Breckenridge, Chairman of the Committee on Safety of Medicines, said: "We have concluded that, at the present time, the balance of risks and benefits for cisapride is not favourable. There are several alternatives to cisapride available. Patients currently taking cisparide should stop taking it and see their doctor over the next few weeks to discuss their options."
Health Minister Lord Philip Hunt said: "The independent scientific advice of the Committee on Safety of Medicines means that measures short of suspending cisapride marketing authorisations are not adequate to protect UK public health, which is of course our priority."
Cisapride marketing has also been suspended in Germany, Canada and the United States among other countries.