Country |
Effective Date |
Description of action taken
Grounds for decision |
Armenia |
July 2000 |
Cisapride has been voluntarily withdrawn because of the increased risk of cardiac arrhythmias in patients taking other medications or suffering from underlying conditions known to increase risk of cardiac arrhythmias. (Reference: Communication to WHO, 9 August 2000). |
Brunei Darussalam |
September 2000 |
The Drug Advisory Committee of the Ministry of Health has withdrawn cisapride (Prepulsid) from the market because of reports of serious cardiovascular adverse effects. (Reference: Official letter to WHO from Medical and Health Services Headquarters, Ministry of Health, Brunei Darussalam, 30 September 2000.) |
Canada |
7 August 2000 |
Health Canada has withdrawn cisapride because of the possibility of rare but serious heart complications including arrhythmias and sudden death. (Reference: Warnings Health Canada, 31 May 2000.) |
Colombia |
May 2000 |
The Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in Colombia, Colombian Ministry of Health has restricted the use of cisapride. It should be made available only if other therapeutic management is insufficient. (Reference: Letter from INVIMA to WHO, 21 August 2000.) |
Germany |
June 2000 |
The Federal Institute for Drugs and Medical Devices has suspended the marketing authorization of cisapride because of the association with cardiac arrhythmias and a number of deaths. (Reference: Communication to WHO, 3 July 2000.) |
Ireland |
September 1999 |
The Irish Medicines Board has restricted the indications for cisapirde following reports of cardiac arrhythmia, cardiac arrest and sudden death. (Reference: Irish Medicines Board, Drug Safety Newsletter.) |
Japan |
October 2000 |
The Ministry of Health and Welfare, Tokyo has decided to suspend marketing authorization of cisapride until its risk/benefit ratio is further revi ewed. (Communication to WHO, 18 October 2000.) |
Mauritius |
July 2000 |
Cisapride was withdrawn from the market following reports of adverse cardiac events published by the FDA. (Reference: Letter to WHO from the Ministry of Health and Quality of Life, Port Louis, Mauritius, 27 December 2000.) |
New Zealand |
|
The Therapeutics section of the Ministry of Health, Wellington has severely restricted the use of cisapride in view of reports of cardiac arrhythmias associated with its use particularly in conjunction with erythromycin, clarithromycin, fluconazole, itraconazole or miconazole. (Reference: Prescriber Update No.14, February 1997.) |
Oman |
April 2000 |
The Directorate General of Pharmaceutical Affairs & Drug Control has suspended the marketing of cisapride because of the possibility of rare but serious heart complications including arrhythmias and sudden death. (Reference Circular No. 28/2000 Directorate General of Pharmaceutical Affairs, Ministry of Health, Sultanate of Oman, 30 April 2000.) |
Philippines |
2000 |
The Department of Health Bureau of Food and Drugs has banned the use of cisapride because of documented reports on adverse events including deaths associated with its use. (Reference: Administrative Order No.97 s 2000, 9 August 2000. Communication from the Department of Health and Bureau of Food and Drugs to WHO, 15 August 2000.) |
United Arab Emirates |
15 April 2000 |
Indications for use of cisapride have been severely restricted because of the risk of rare but serious cardiac events associated with the drug. (Reference: Communication with WHO, 10 July 2000.) |
United Kingdom |
July 2000 |
The Medicines Control Agency has withdrawn cisapride from the market because of rare but serious cardiac adverse effects. (Reference: Advice from the Medicines Control Agency, 21 July 2000.) |
USA |
April 2000 |
Cisapride has been voluntarily withdrawn from the market because of the risk of rare but serious cardiac events associated with the drug. These include heart rhythm disorders and deaths associated mostly with the use of the drug in people who are either taking certain other medications or who have certain underlying conditions that are known risk factors. (Reference: www.fda.gov/medwatch/safety/2000/propull.htm) |
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