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Back To Vidyya UK Regulatory Agency Moves For Withrawl Of Cisapride

Cisapride (Prepulsid) Used For Treatment Of Gastric Reflux

The Medicines Control Agency (MCA) 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. There are several therapeutic alternatives to cisapride for gastro- oesophageal reflux disease and functional dyspepsia. These include general lifestyle measures, antacids, H2 antagonists (e.g. cimetidine and ranitidine), prokinetic agents (e.g. metoclopramide and domperidone) and proton pump inhibitors (e.g. omeprazole).

Stopping cisapride does not carry any risk. Health professionals have been infomed 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 unexplained 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.

Glossary:

The Medicines Control Agency - Agency of the Department of Health, responsible for all aspects of the regulation of medicines in the UK. This includes: the regulation of clinical trials, licensing of medicines and monitoring their safety once on the market, investigating possible hazards and taking appropriate action to minimise the risks to users, inspection of premises manufacturing medicines and taking enforcement action if activities fall outside the law.

The Committee on Safety of Medicines is an independent expert advisory committee established under Section 4 of the Medicines Act 1968 to advise the Licensing Authority on questions of safety, quality and efficacy of medicines for human use. The Committee also advises the Licensing Authority on the collection and interpretation of data on adverse drug reactions.

Cisapride (Prepulsid - Janssen Cilag) is a gut motility stimulant indicated for a number of conditions including:

  • The treatment of symptoms (e.g. heartburn and regurgitation) associated with gastro-oesophageal reflux disease (GORD)
  • the maintenance treatment of reflux oesophagitis (acid reflux)
  • the management of symptoms of dyspepsia (e.g. epigastric pain or burning, early satiety, bloating) where peptic ulcer or other lesions have been excluded from the diagnosis
  • the relief of symptoms (e.g. nausea, early satiety, anorexia, bloating, epigastric pain) of impaired gastric motility secondary to disturbed and delayed gastric emptying associated with diabetes, systemic sclerosis and autonomic neuropathy.

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Editor: Susan K. Boyer, RN
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