| October 17, 2000 |
Supply of Acenalin® (cisapride) products to be temporarily suspended |
Janssen-Kyowa Co., Ltd, manufacturer of Acenalin ® (generic name: cisapride), will temporarily suspend the supply of Acenalin ® (a prokinetic), effective October 17, 2000. In Japan, cisapride products were launched under the trademark Acenalin ® manufactured by Janssen-Kyowa and marketed by Kyowa Hakko Kogyo Co., Ltd., and under the trademark Risamol manufactured and marketed by a licensee, WelFide Corporation in 1989. Both cisapride products have been widely prescribed for eleven years since the launch in Japan and a post-marketing evaluation was completed in 1998. Cisapride remains a safe and effective treatment when prescribed appropriately in line with the approved dose and labeling. The Janssen-Cilag companies have been in discussion with Health Authorities in different countries worldwide to ensure appropriate use of cisapride taking into consideration the risk and benefit profile of cisapride, after serious cardiac adverse events were reported in western countries. No fatal cases of cardiac adverse events have been reported in Japan. While having reported the safety data of cisapride in Japan as well as the regulatory status of overseas countries to regulatory authorities, Janssen-Kyowa has also been discussing with regulatory authorities about the actions to take in order to ensure the safe and appropriate use in Japan. Based upon the result of the discussion, Janssen-Kyowa and Kyowa Hakko will temporarily suspend the supply of Acenalin ® products. |
