Reports of side effects from medicines up
7 April 2005, BRUSSELS – The number of Belgian patients reporting serious side effects from medicines is rising, it emerged on Thursday.
7 April 2005
BRUSSELS – The number of Belgian patients reporting serious side effects from medicines is rising, it emerged on Thursday.
Almost 3,000 cases were registered with the Belgian Centre of Pharmaceutical Information in 2004 – an increase of 30 percent on the previous year.
In five cases the secondary effects of the medicine the patients took were fatal, although in one case the death was not judged to have been caused by the medicine.
One of the cases was clearly linked to the drug taken while in the other three the drug may have played a role in the deaths.
Of the 2,945 cases reported, some 2,655 were registered by the drug companies themselves, in keeping with their legal obligation to register side effects.
Only serious cases warranting further investigation are reported.
The Belgian pharmaceutical watchdog, registered by the Department of Health, passes its reports on to the World Health Organisation which compiles data on around 50 countries.
Drug companies must also compile regular reports on medicines’ side effects under EU law.
As a result, warnings on medicines are changed and products may also be withdrawn from the market.
Between January 2004 and February, 114 medicines were withdrawn from sale.
In the majority of cases the products were not withdrawn due to side effects, but to other factors such as poor sales or the development of replacement drugs.
However, the company Merck, Sharp and Dohme did withdraw the anti-inflammatory pill Vioxx late last year due to reports over side effects.
[Copyright Expatica 2005]
Subject: Belgian news