In 2000, the former Medicines Control Agency (now the Medicines and Healthcare products Regulatory Agency) and the Committee on Safety of Medicines (CSM) conducted a thorough review of the balance of risks and benefits of cisapride (Prepulsid, licensed for the treatment of motility-related gastrointestinal disorders). As cisapride was also authorised in other European Union (EU) Member States, a safety review by the European Committee for Proprietary Medicinal Products (CPMP) was also taken forward at this time.
Following careful review of efficacy studies and consideration of reports of suspected cardiac adverse reactions, the CSM concluded that the balance of risks and benefits for cisapride was no longer favourable and the Licensing Authority suspended the UK marketing authorisations (MAs) pending the outcome of the EU review. Following an opinion of the CPMP, the European Commission issued a Decision in May 2002 allowing restricted MAs for cisapride for use in certain indications in clinical trials or via a safety registry.
However, the UK MAs remained suspended until