Brussels, 17/09/2001 (Agence Europe) - At a meeting of the European Parliament's Environment, Health and Consumer Policy Committee on Thursday, MEPs expressed concern at the risks inherent in the use of medicines. They questioned the Executive Director of the European Agency for the Evaluation of Medicinal Products (EMEA), Thomas Lönngren, about the effectiveness of medicines monitoring in Europe. Returning to the cerivastatin affair which was in the headlines this summer and forced Bayer Laboratories to withdraw its anticholestoral medicine from the market after it resulted in the deaths of more than 50 people, Giuseppe Nistico of Forza Italia seriously questioned the medical surveillance systems. German Green Hiltrud Breyer called for stricter EU rules after the deaths of 33 people from cardiovascular disease after taking Viagra. Mr Lönngren explained that it had been authorised by national authorities as part of the mutual recognition process and that the EMEA itself had not been involved in checking the safety of Viagra. At the beginning of July the EMEA launched an enquiry into the statin family (including Viagra) in order to find out how frequently undesirable side effects occurred, and will be publishing its report before November. The counter-indications and side effects of Viagra are well known, particularly when taken together with vasodilators and vasoconstrictors. Mr Lönngren highlighted the role of the prescribing doctor who has to be particularly vigilant and provide adequate information to the patient.
Mr Lönngren said that some pharmaceutical firms neglected monitoring and called for a system of sanctions, welcoming the recent proposals to strengthen the monitoring of medicines at Community level (see EUROPE of 19 July, p.7). The Environment Committee's President, Caroline Jackson (Conservative, UK), suggesting drawing up a list of companies and Member States that do not respect medicine monitoring regulations.