Cisapride (Prepulsid) will stop being marketed in the US this summer but will still be available through a limited access protocol.
Dr Robert Donnelly (medical director, Janssen-Cilag, UK) told The Journal on March 27 that recent label changes for cisapride had been more severe than the corresponding changes in the UK.
In January, the Food and Drug Administration decided that all patients should have an ECG before taking cisapride but, in the UK, this was only the case for "at risk" patients. Janssen's decision to stop marketing cisapride was voluntary. Dr Donnelly also pointed out that the maximum doses differed, with the UK dose (40mg) being half that of the US dose (80mg) and, in addition, indications for cisapride differed between the two countries. Dr Donnelly said that the company had informed the Medicines Control Agency of the situation.
A spokeswoman for the Department of Health told The Journal on March 28 that the MCA would be reviewing the advice given on cisapride in light of the action taken in the US. In addition, the European Pharmacovigilance Working Party (part of the Committee for Proprietary Medicinal Products) reviewed the safety of cisapride on March 28. Its findings were not available at the time The Journal went to press.
She added that, in the UK, the product information gave clear advice and that there was no need for patients to seek medical advice unless they developed any symptoms.