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EMEA on cough drug risks

This article was originally published in The Tan Sheet

Executive Summary

The European Medicines Agency concludes the risks of OTC clobutinol-containing cough medicines are greater than their benefits and on Oct. 18 recommends the European Commission withdraw the products' marketing authorizations. Most of these medicines were marketed in Europe by Boehringer Ingelheim under the brand Silomat, but the firm on Aug. 31 withdrew the product from all its markets after regulators in Germany suspended marketing authorization there. Following Germany's decision, EMEA's Committee for Medicinal Products for Human Use concluded the use of clobutinol is linked to a risk of fainting and disruption of the heart rhythm, especially when taken in higher doses. EMEA says clobutinol-containing cough medicines also are available in Austria, Belgium, the Czech Republic, Finland, France and Greece. The EC has not set a schedule for rendering a decision on the recommendation...

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