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The Swiss drug regulator, Swissmedic, has ordered the withdrawal of Novartis Pharmaceutical's IBS drug Tegaserod (Zelmac®, Zelnorm®) after an analysis of new data found an increased risk of cardiovascular conditions including angina pectoris and heart attack with this medication compared to placebo.
"After careful analysis of the complete data, the risk-benefit ratio for Zelmac® now appears unfavourable, so that Swissmedic has refused to extend the product licence." the regulatory agency said in a statement.
Novartis pulled Tegaserod from the U.S. market earlier this year at the request of the U.S. Food and Drug Administration due to similar concerns.
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Epidemiological studies describing population characteristics which collect data at one point in time and then consider relationships between observed characteristics.. Because they don't look at time trends they cannot establish causes.
