WHO Drug Information Vol. 15, No. 3 & 4, 2001: Regulatory and Safety Matters*: Continued suspension for tolcapone

WHO Drug Information Vol. 15, No. 3 & 4, 2001
(2001; 76 pages)

Table of Contents

	WHO Drug Information
	Personal Perspectives
		Internet pharmacies: advantages and risks
	Reports on Individual Drugs
		Atypical antipsychotics and impaired glucose metabolism
		Antituberculosis drugs: hepatobiliary reactions
	Quality Assurance Issues
		WHO pilot pre-qualification project for pharmaceutical products
	Current Topics
		Antimicrobials in animal feed: a threat to human use
		Declaration of Helsinki and placebo-controlled clinical trials
	General Information
		Improving the quality and usefulness of drug regulatory authority websites
	Regulatory and Safety Matters*
		Infliximab and congestive heart failure
		Infliximab: warning of opportunistic infections
		Brimonidine ophthalmic drops: accidental ingestion
		P-Glycoprotein and drug interaction
		Nonacog alfa: intensive surveillance
		Tenofovir disoproxil fumarate approved for HIV infection
		Ciprofloxacin hydrochloride for inhalation anthrax
		DTPa and limb swelling
		Nitrofurantoin and peripheral neuropathy
		Continued suspension for tolcapone
		MMR vaccine and idiopathic thrombocytopenic purpura
		New communications and networking unit at EMEA
	ATC/DDD Classification
		Final list
		Temporary list
	Regulatory Information
		Internet purchase of pharmaceuticals: a review of regulatory experience*
	Recommended International Nonproprietary Names (rec. Inn): List 46
	Selected WHO Publications of Related Interest

Continued suspension for tolcapone

European Union -Tolcapone (Tasmar®) was marketed in August 1997 for the treatment of Parkinson disease in 100 mg and 200 mg film-coated tablets.

In November 1998, the Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) recommended suspension of tolcapone following reports of severe hepatotoxicity. Subsequently, the suspension was renewed in October 2000.

In September 2001, evidence was reviewed and the benefit/risk profile re-assessed and the CPMP have recommended renewal of the suspension for a further year pending the results of an ongoing prospective trial on comparable treatments.

Reference: EMEA Press Release, 26 September 2001. http://www.emea.eu.int