Pharmaceuticals: Restrictions in Use and Availability
(2001; 40 pages) View the PDF document
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Open this folder and view contentsIntroduction
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View the documentAlatrofloxacin mesilate
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View the documentAmfepramone hydrochloride
View the documentAristolochia
View the documentAstemizole
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View the documentBuspirone hydrochloride
View the documentCamphor
View the documentChlormezanone
View the documentCisapride
View the documentDantron
View the documentDequalinium
View the documentDexfenfluramine hydrochloride
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View the documentDronabinol
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View the documentEpoetin alfa and epoetin beta
View the documentErythrityl tetranitrate
View the documentFenfluramine
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View the documentFurazolidone
View the documentGentamicin (topical preparations)
View the documentGrepafloxacin hydrochloride
View the documentGinkgo biloba
View the documentKetamine hydrochloride
View the documentKetorolac
View the documentLamivudine
View the documentLevamisole hydrochloride
View the documentLexipafant
View the documentLoxoprofen sodium
View the documentMedifoxamine
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View the documentMetamizole sodium
View the documentMethylrosanilinium chloride
View the documentMetoclopramide (paediatric)
View the documentMibefradil
View the documentMisoprostol
View the documentNandrolone
View the documentOxeladin citrate
View the documentPexiganan
View the documentPhenolphthalein
View the documentPhentermine
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View the documentPhenylbutazone
View the documentPiperazine
View the documentPromethazine
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View the documentPyrithione zinc
View the documentPumactant
View the documentRituximab
View the documentSertindole
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View the documentSulfaguanidine
View the documentTerfenadine
View the documentTilbroquinol
View the documentTolcapone
View the documentTramadol
View the documentTroglitazone
View the documentTrovafloxacin mesilate
View the documentZopiclone
Open this folder and view contentsCombination Products
Open this folder and view contentsGroup Products
 

Cisapride

Product name:

Cisapride

CAS number:

810968-60-4

Synonyms:

Cisapridum; R-51619

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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