Pharmaceuticals: Restrictions in Use and Availability
(2001; 40 pages) View the PDF document
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Open this folder and view contentsCombination Products
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Metamizole sodium

Product name:

Metamizole sodium

CAS number:

68-89-3

Synonyms:

Dipyrone; Noramidopyrine methanesulfonate sodium; Methanesulfonic acid,[(2,3-dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl) methylamino]-, sodium salt

Country

Effective Date

Description of action taken
Grounds for decision

Armenia

February 2000

The Drug and Medical Technology Agency has suspended the marketing authorization of metamizole sodium (tablets and solution). The decision is based on a large number of reports on agranulocytosis in Sweden since 1996 and other dangerous adverse effects. (Reference: Communication to WHO, 9 August 2000.)

Colombia

June 2000

The Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in Colombia, Colombian Ministry of Health has restricted the use of metamizole either alone or in combination. These products should be available only if other therapeutic management is insufficient. (Reference: Resolucion No. 259048, INVIMA, 22 June 2000, Ministerio de Salud.)

Morocco

May 2000

The Minister of Public Health has decided to suspend the marketing authorization for products containing metamizole sodium on the recommendation of the National Advisory Commission for Pharmacovigilance. This recommendation followed an official survey which showed severe adverse reactions associated with this product. (Reference: Letter from the Direction du médicament et de la pharmacie, Rabat, 8 September 2000.)

Sweden

1999

The Medical Products Agency has suspended the marketing authorization for metamizole sodium with effect from 28 April 1999. The decision is based on a larger than expected number of reports of agranulocytosis in Sweden since 1996 (1 in 1,700). (References: EU/EEA Rapid Alert, Läkemedelsverket (Medical Products Agency), 28 April 1999.)

Syria

1998

The Suprim Technical Committee and the Ministry of Health has instructed all local drug factories to stop manufacturing metamizole sodium (dipyrone) ampoules with immediate effect. (Reference: Announcement from the Directorate No: 1784 dated 2/2/98.)

Yemen

1998

The Supreme Board of Drugs and Medical Appliances has withdrawn all formulations of metamizole sodium because of its potential to cause anaphylactic shock and agranulocytosis. (Reference: Communications from WHO Representative, Yemen, 17 December and 10 October 1998.)

Zimbabwe

1998

The Medicines Control Authority has cancelled the registration of all metamizole sodium (dipyrone)- containing products due to the potential risk of metamizole sodium causing fatal agranulocytosis. (Reference: Drug Information Bulletin Vol.2, No.1, March 1998.)

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