Finalising a review of the safety of clobutinol-containing cough medicines in the European Union (EU), the European Medicines Agency (EMEA) concluded that the risks of these medicines are greater than their benefits and recommended that the marketing authorisations for these medicines be withdrawn throughout the EU. Medicines containing clobutinol are available without a prescription in a number of EU Member States for the short-term treatment of irritable, non-productive cough (where the patients do not cough up any phlegm or mucus). Most of these medicines were marketed by Boehringer Ingelheim under the tradename Silomat.
The review of clobutinol-containing medicines was started in September 2007, following the suspension of the marketing authorisations for these medicines by the German competent authority, because preliminary results of a study indicated that the use of clobutinol was linked to side-effects affecting the heart. After Germany had informed the EMEA about the suspension, the Committee for Medicinal Products for Human Use (CHMP) started reviewing the safety of these medicines to reach a conclusion on whether the regulatory actions taken by Germany should be implemented throughout the EU.
Having considered all available evidence, the CHMP concluded that the use of clobutinol is associated with a risk of prolongation of the 'QT interval': this can affect the heartbeat, and is known to be linked to fainting and disruption of the heart rhythm, especially when taken in higher doses. In the light of these findings and because clobutinol is used to treat a common complaint for which alternative treatments are available, the CHMP considered that the benefits of these medicines do not outweigh their risks. The CHMP therefore recommended the withdrawal of the marketing authorisations of all clobutinol-containing medicines in the EU.
The CHMP opinion will now be sent to the European Commission for the adoption of a decision, applicable in all EU Member States.
For further information, please visit:
www.emea.europa.eu