Product name:

Tolcapone

CAS number:

134308-13-7

Synonyms:

3,4-Dihydroxy-4'-methyl-5 nitrobenzophenone; 3,4-Dihydroxy-5-nitrophenyl (4- methylphenyl)metahanone

Country

Effective Date

Description of action taken
Grounds for decision

Australia

February 1999

Following overseas reports of serious and unpredictable hepatotoxicity associated with the use of the catechol-O-methyl transferase inhibitor, tolcapone (TamarR), including 3 fatalities, its registration has been withdrawn in Australia. (Reference: Australian Adverse Drug Reactions Bulletin Vol.18, No.1, February 1999.)

Bulgaria

April 1999

The Bulgarian Drug Agency in the Ministry of Health withdrew the antiparkisonism agent, tolcapone because of serious adverse reactions worldwide. (Ref: Communication to WHO from the Bulgarian Drug Agency, Ministry of Health, Bulgaria.)

EMEA

November 1998

The European Agency for the Evaluation of Medicinal Products has recommended the suspension of the marketing authorization for tolcapone. This follows several reports of severe and unpredictable hepatic reactions including fatal fulminant hepatitis. (Reference: Press release from the European Agency for the Evaluation of Medicines. 17 November 1998.)

Iceland

November 1998

The State Committee on Pharmaceuticals in Iceland withdrew the marketing authorization for tolcapone due to serious adverse effects. Since then the product has been available to specialist neurologists for the treatment of severe cases of Parkinson's disease. (Reference: Communication to WHO from the State Committee on Pharmaceuticals in Iceland, 17 October 2000.)

Lithuania

December 1998

The State Medicines Control Agency has withdrawn from the market tablets of tolcapone. (Reference: Order of State Medicines Control Agency No. 123, 15 December 1998.)

Singapore

The National Pharmaceutical Administration in the Ministry of Health has restricted the use of tolcapone to neurologists as there are concerns over reports of severe hepatotoxicity associated with the use of the drug. (Reference: Communication to WHO, 2 August 2000.)

United Kingdom

November 1998

The manufacturer of the antiparkinsonism drug, tolcapone has voluntarily withdrawn it from the market. This follows a review of the hepatotoxic effects by the European Committee for Proprietary Medicinal Products (CPMP) which found that the overall balance of risks and benefit was no longer favourable. (Reference: Communication to WHO, 30 August 2000 from the Medicines Control Agency, Department of Health, United Kingdom.)