WRITTEN QUESTION No. 3886/98 by Anna KARAMANOU Adverse effects of Viagra on health
Date: 1999-01-04
Institutions: European Parliament, KARAMANOU
Subjects: European Medicines Agency, cardiovascular disease, consumer protection, drug surveillance, marketing, medical research, medicinal product, new product, product safety, scientific research

6.11.1999

EN

Official Journal of the European Communities

C 320/85

(1999/C 320/113)

WRITTEN QUESTION E-3886/98

by Anna Karamanou (PSE) to the Commission

(4 January 1999)

Subject: Adverse effects of Viagra on health

The recent announcement by the Federal Drugs Agency that three Viagra users have recently died in Germany
is cause for legitimate concern about the safe use of the drug. Given that the cause of death in all three cases
was a heart attack, it is considered quite probable that Viagra played a part in these fatalities. What measures
has the Commission taken to protect the health of European citizens and, in particular, to ensure that they are
responsibly informed?

Answer given by Mr Bangemann on behalf of the Commission

(23 February 1999)

Authorisation for placing Viagra on the market was granted by the Commission on 14 September 1998 on the
basis of the scientific evaluation carried out by the European Agency for the Evaluation of Medicinal Products
which delivered a favourable opinion on the request for authorisation to place the product on the market. In
the scientific evaluation the safety of this medicine for users was carefully examined.

In the summary of product characteristics it is specified (under contra-indications) that this medicine must not
be used by men for whom sexual activity is inadvisable, in particular patients with severe cardiovascular
problems such as unstable angina pectoris or severe cardiac insufficiency. It is also mentioned (under special
warnings and special precautions for use) that before commencing such treatment the doctor must carry out
an examination of the patient’s cardiovascular function as all sexual activity involves some cardiac risk. In the
information for the patient it is clearly specified that he should not take Viagra in case of severe cardiac
problems, a recent heart attack or low blood pressure.

In the scientists’ view consumer protection is therefore guaranteed provided that the precautions for use and
contra-indications are heeded.

(1999/C 320/114)

WRITTEN QUESTION E-3896/98

by Hiltrud Breyer (V) to the Commission

(4 January 1999)

Subject: EU subsidies for exports of live cattle from the EU to third countries

Given that the protection of livestock must have priority over economic interests, why were exports of live
cattle not excluded from the most recent 8 % increase in export refunds, which came into effect on
17.10.1998 (1), and subsidies granted only to exports of meat?

(1) O J L 281, 17.10.1998, p. 17.

Answer given by Mr Fischler on behalf of the Commission

(10 February 1999)

Export refunds on live cattle have been granted since the common market organisation for the beef sector was
introduced in 1968 and there is a traditional export trade to certain countries. In 1997 live exports of adult
animals accounted for some 8 % of total refund-aided exports for the sector of 1 050 000 tonnes (carcase
weight).