EU Chief Calls for Closer Focus on Drug Safety

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And just think they banned vitamins which were not harmful and gave the ok to prescription drugs to have them over the counter without prescription, something is not making sense, unless they are trying to kill us off?___________________________ http://www.reuters.com/newsArticle.jhtml?type=healthNews & storyID=7878811 & src=rss/healthNews | | | EU Chief Calls for Closer Focus on Drug SafetyFri Mar 11, 2005 10:07 AM ET By Ben Hirschler, European Pharmaceuticals Correspondent LONDON (Reuters) - Europe must do more to ensure the safety of medicines following recent product scandals, European Commission Vice President Guenter Verheugen said on Friday. He told a meeting of the European Medicines Agency (EMEA) that new monitoring mechanisms -- some of which will be introduced this year -- were needed to track adverse side effects of medicines after launch. "As recent product withdrawals have reminded us, we cannot know the safety profile of all products at the time of authorization. Therefore, we must have systems in place to learn more about the safety of medicines once they are marketed," he said. The global pharmaceuticals industry was rocked last year by the withdrawal of Merck & Co Inc's blockbuster painkiller Vioxx, which triggered tough new warnings on the safety of all so-called COX-2 drugs. A serious safety problem also emerged last year over selective serotonin reuptake inhibitor (SSRI) antidepressants after they were linked to suicidal behavior in a minority of patients. Professor Munir Pirmohamed of Liverpool University said such episodes highlighted the inadequacy of post-marketing surveillance schemes that relied on healthcare professionals reporting adverse events spontaneously. "A major problem with all such schemes is the degree of under-reporting of ADRs (adverse drug reactions). Even with fatal reactions, less than one in 10 reactions may be reported," he said. Verheugen said new European laws, which will come into force by November, would allow the EMEA to play a more significant role in monitoring the safety of medicines after launch -- but it remained to be seen whether further steps might be needed. "An ongoing study launched by the Commission into the robustness of the system should tell us whether these measures are sufficient," he said in a speech delivered on his behalf. Verheugen was unable to attend the event to mark the 10th anniversary of the EMEA in person due to illness. STRONGER SAFETY NET Continued ... © Reuters 2005. . 1 | 2 Next Reuters.com Help & Info. | Contact Us | Feedback | Advertise | Disclaimer | Copyright | Privacy | Corrections | Partner Newspapers