Product name:

Mibefradil

CAS number:

116644-53-2

Synonyms:

(1S,2S)-(2-{[3-(2-Benzinidazoylyl)propyl]methylamine}-ethyl-6-fluoro-1,2,3,4- tetrahydro-1-isopropyl-2-naphthyl methoxyacetate dihydrochloride

Country

Effective Date

Description of action taken
Grounds for decision

Armenia

July 2000

Mibefradil has been voluntarily withdrawn on the basis of a large number of reports of life-threatening interactions of the drug: extremely low heart rates and a risk of muscle injury. (Reference: Communication to WHO, 9 August 2000.)

Bulgaria

April 1999

The Bulgarian Drug Agency in the Ministry of Health withdrew the calcium channel blocking agent, mibefradil (Posicor) because of serious adverse reactions worldwide. (Reference: Communication to WHO from the Bulgarian Drug Agency, Ministry of Health, Bulgaria.)

Germany

August 1998

The Federal Institute for Drugs and Medical Devices has suspended the marketing authorization for mibefradil because it considers that mibefradil has a negative benefit/risk ratio. In particular, it has a life-threatening potential to induce cardiac arrhythmias (including torsades de pointes) especially when taken concomitantly with other medications. (Reference: Communication from the Federal Institute for Drugs and Medical Devices, 21 August 1998.)

Jamaica

February 1998

The calcium channel blocking agent, mibefradil was voluntarily withdrawn from the market by Hoffman La Roche. (Reference: Communication to WHO from The Ministry of Health, Standards and Regulation, Kingston, Jamaica, 26 September 2000.)

Peru

1998

La Direcciòn General de Medicamentos, Insumos y Drogas (DIGEMID) of the Ministry of Health withdrew marketing authorization for mibefradil (Posicor) following reports of serious adverse effects caused by the interaction with other medicines. (Reference: Alerta DIGEMID No. 04-98, 1998.)

South Africa

1998

The South African Medicines Control Council has withdrawn products containing mibefradil because of safety concerns in relation to potential for serious drug interactions.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

United Kingdom

July 1998

Mibefradil was voluntarily withdrawn from the market by the manufacturer worldwide due to an increasing number of reports of serious interactions with a wide range of drugs. (Reference: Communication to WHO, 30 August 2000 from the Medicines Control Agency, Department of Health, United Kingdom.)

USA

1998

Roche laboratories announced the voluntary market withdrawal of the antihypertensive and antianginal medication mibefradil (Posicor). This action was taken because of information on a number of drug interactions, some of them serious that occur when mibefradil is taken together with other medications. (Reference: Dear Doctor letter of June 8 1998. www.fda.gov/medwatch/safety/1998.)