Doctors in the United States are being advised to carry out an ECG in all patients before prescribing cisapride (Prepulsid). The Food and Drug Administration has suggested that an ECG is advisable to help avoid giving the drug to patients at risk of rare, but serious, cardiac side effects. In the UK, a pre-treatment ECG is currently recommended for patients with risk factors for cardiac abnormalities, but not for all patients.
Dr Robert Donnelly (medical director, Janssen Cilag) said on March 14 that the company did not think that ECGs were necessary for all patients in Europe and that the Medicines Control Agency was believed to hold the same view. However, the company was currently in discussion with the MCA about a licence variation to strengthen the current precautions.