WRITTEN QUESTION No. 4015/98 by Graham MATHER Licensing suspension for Tasmar (Tolcapone)
Date: 1999-01-08
Institutions: European Parliament, MATHER
Subjects: European Medicines Agency, health risk, market approval, marketing restriction, medicinal product, pharmaceutical legislation, pharmacology, public health, trade licence

C 289/112

Official Journal of the European Communities

EN

11.10.1999

Although the problem of nuclear safety is one which particularly affects the candidate States of Central and
Eastern Europe, with their legacy of Soviet-design nuclear power reactors, all candidate States must ensure that
the levels of technological and operational safety comply with current practice in the Union.

As regards Turkey, the European Council has confirmed Turkey’s eligibility for accession to the Union, whilst
recognising that the political and economic conditions allowing accession negotiations to be envisaged are not
yet satisfied. Therefore, for the immediate future the question posed by the Honourable Parliamentarian on
Turkey does not arise in the context of enlargement. Nonetheless, the Council will not neglect the question of
nuclear safety in the framework of the Union’s current relations with Turkey.

(1999/C 289/147)

WRITTEN QUESTION E-4015/98

by Graham Mather (PPE) to the Commission

(8 January 1999)

Subject: Licensing suspension for Tasmar (Tolcapone)

The Commission recently initiated a procedure whereby Member States are requested to suspend the licensing
of Tasmar as of 17 November.

This has raised concerns among sufferers of Parkinson’s Disease in the United Kingdom.

Can the Commission please provide a full explanation for this decision and details of any contact it has had
with the US Food and Drugs Administration on this matter?

Answer given by Mr Bangemann on behalf of the Commission

(29 January 1999)

The procedure concerning the suspension of the marketing authorisation for the medicinal product tolcapone
(TASMAR) was finalised by Commission Decision on the 11 December 1998, in accordance with the opinion
of the standing committee in which the Member States are represented.

The decision was taken following the scientific evaluation made by the European agency for the evaluation of
medicinal products which recommended the suspension of the marketing authorisation.

The scientific evaluation, indicates that it was impossible to guarantee the safe use of this medicinal product for
the following reasons:

7 serious hepatic reactions occur unpredictably and liver monitoring does not seem to be able to predict the

development of severe, sometimes fatal, hepatic disease;

7 taking into consideration this hepatotoxicity, as well as the possible occurrence of rhabdomyolysis and
neuroleptic malignant-like syndrome, the overall benefit to risk balance of tolcapone was considered to be
unfavourable in the authorised indication and it was not felt possible to restrict the indications sufficiently
to permit safe use.

The procedure and the decision were made on the basis of the information provided to the European
competent authority. Similar concerns had been identified by the United States Food and drugs administration
(FDA), and the decision of the Commission has been communicated to the FDA.