WRITTEN QUESTION E-0912/00

by Hiltrud Breyer (Verts/ALE) to the Commission

(29 March 2000)

Subject: Viagra

1. Why has viagra been authorised as a drug by the European Agency for the Evaluation of Medicinal Products although, in trials, out of 4000 people taking part, 22 cases of death occurred in the group to which the active substance was administered (compared with two deaths in the group to which a placebo was administered)?

2. In view of the dramatic increase in deaths linked to viagra, does the Commission consider that authorisation should be withdrawn, and, if not, what are its reasons?

3. What does the Commission intend to do in the face of the increasing number of deaths linked to viagra?

4. Could the Commission explain why, at the forthcoming meeting between the Agency for the Evaluation of Medicinal Products and representatives of the Member States, viagra will again not be on the agenda despite the large number of deaths?

5. Is the Commission aware that the product information given in the package leaflet is incomplete? What action does it intend to take about this?

Answer given by Mr Liikanen on behalf of the Commission

(12 May 2000)

1. The Commission authorised Viagra on the basis of a favourable opinion from the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products (EMEA). The clinical trial reports indicating 22 deaths with Viagra as opposed to 2 deaths with the placebo fail to take account of the different number of patients in each group and the duration of the treatment. In fact, the rates are comparable, at around 0,5 deaths per 100 patients treated over the course of one year. Moreover, analysis suggests that none of these 22 deaths is attributable to treatment with Viagra.

2. To date there have been no data to suggest a dramatic increase in the number of deaths, even though the number of patients treated has risen from a few thousand to several million. It must be borne in mind that this is a medicinal product intended for patients suffering from erectile dysfunction, which affects more than 50 % of men over the age of 70. This means that, in many cases, death may be due to vascular problems.

3. The Commission ensures that holders of authorisation to place products on the market send the EMEA regular data on safety. For Viagra, the holder has been asked to supply such data on a monthly basis, i.e. more regularly than is normally required.

4. Viagra is being monitored closely, and there is no need to alter the current position. Should new information indicate otherwise, measures would be taken without delay to protect patients.

5. The information given in the package leaflet has also been evaluated by the EMEA and authorised by the Commission. Using language accessible to patients, it includes all the information given in the summary of product characteristics intended for health care professionals. Any changes to the summary are automatically made to the leaflet.