Product name:

Astemizole

CAS number:

68844-77-9

Synonyms:

1[(4-fluorophenyl)methyl]-N-[1-[2-(4-methoxyphenyl)ethyl]- 4-piperidinyl]-1H- benzimidazol-2-amine

Country

Effective Date

Description of action taken
Grounds for decision

Armenia

July 2000

Astemizole has been voluntarily withdrawn on the basis of prolongation of the QT-interval and ventricular arrhythmias. (Reference: Communication to WHO, 9 August 2000)

Brunei Darussalam

July 1999

The manufacturer withdrew astemizole worldwide because of serious adverse cardiovascular reactions. (Reference: Official letter to Regulatory Agencies, Jansses-Cilag, 1 July 1999.)

Mauritius

June 1999

Astemizole was withdrawn from the market following reports of adverse drug reactions published by the FDA and the decision of Janssen Pharmaceutica to remove the drug in the USA. (Reference: Letter to WHO from the Ministry of Health and Quality of Life, Port Louis, Mauritius, 27 December 2000.)

Philippines

1998

The Department of Health Bureau of Food and Drugs have noted the voluntary withdrawal by the sponsoring company of the antihistamine, astemizole due to its association with severe cardiac adverse events when used inappropriately with contraindicated drugs. (Reference: Communication from the Department of Health and Bureau of Food and Drugs to WHO, 15 August 2000.)

Singapore

The National Pharmaceutical Administration in the Ministry of Health has banned astemizole since it has been associated with adverse drug reactions including irregular heart rhythms and severe allergic reactions if taken at higher than recommended doses or in conjunction with some other drugs including antihypertensives and anti-asthmatics. (Reference: Communication to WHO, 2 August 2000.)

South Africa

1999

The South African Medicines Control Council has withdrawn products containing astemizole because of the potential for serious drug interactions. (Reference: Information from the Pharmaceutical Services in the Ministry of Health in South Africa.)

Tanzania

2 July 1999

The Pharmacy Board of the Ministry of Health, in the United Republic of Tanzania has withdrawn astemizole from the market. (Reference: Communication to WHO from the Ministry of Health, Tanzania, 20 November 2000.)

United Kingdom

1998

Astemizole has been reclassified to Prescription only Medicine as a result of new data on interactions from postmarketing surveillance studies. These data highlight an increased risk of QT prolongation with concomitant administration of oral or parenteral formulations of azole antifungals, macrolide antibiotics except azithromycin, selective serotonin reuptake inhibitors, HIV protease inhibitors and mibefradil (now withdrawn worldwide). In addition, astemizole is contraindicated for use in patients with hepatic dysfunction. (Reference: The Pharmaceutical Journal 261, p.9, 4 July 1998.)

United Arab Emirates

June 1999

The Ministry of Health has banned the sale of astemizole with effect from 23 June 1999 on account of increased risk of QT prolongation with concomitant administration of oral or parenteral formulations of azole antifungals, macrolide antibiotics except azithromycin, selective serotonin reuptake inhibitors and HIV protease inhibitors. (Reference: Communication with WHO, 10 July 2000

USA

1999

Janssen, the manufacturer of the histamine H1-receptor antagonist, astemizole, (HismanalR) has announced that it is voluntarily withdrawing the 10-mg formulation from the market. Since the drug's approval in 1988, new adverse reaction data has necessitated a series of labelling changes and warnings. In the light of the choices of other prescription antihistamines now available and the overall risk benefit profile of this drug, the Food and Drug Administration supports the decision of the company to withdraw the product. (Reference: FDA Talk Paper T99-29, 21 June 1999.)