POSSIBLE HEART RHYTHM DISTURBANCE WITH THE COUGH PREPARATIONS ORCINOL AND SILOMAT

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Riyadh October 2007 – The Saudi Ministry of Health has withdrawn the marketing approval for two cough syrups, Orcinol and Silomat, containing clobutinol. The withdrawal in Saudi Arabia is in response to a similar action taken by the European Medicine Agency (EMEA) to ban clobutinol in the European Union. The Saudi Food and Drug Authority (SFDA) agrees with the Ministry of Health’s decision to protect the public health. </p>
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<p>Clobutinol is a cough suppressant. It is used for the short-term treatment of irritable, non-productive cough (a ‘dry’ cough where the patient does not cough up any phlegm or mucus). </p>
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<p>A preliminary study by the German drug regulatory authority found that clobutinol is associated with adverse effects on the heart. These include causing abnormal electrical conduction in the heart called QT prolongation. This adverse effect can lead to fatal heart rhythm disturbance in people using clobutinol. </p>
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<p>Cough suppressants are rarely needed and there are more safe alternative treatments to clobutinol available.</p>
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<p><strong>Actions that the Public and Healthcare Professionals Should Follow: </strong></p>
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<p>You should not use or give your children cough medications containing clobutinol. </p>
<p>Consumers should check their medicine cabinets for cough medications containing clobutinol. This includes cough preparations purchased outside Saudi Arabia. In case of inability to find out the content of your medications, go to the closest pharmacy to your residence. </p>
<p>Clobutinol containing products should be returned to their place of purchase or destroyed. </p>
<p>Physicians must avoid prescribing cough preparations containing clobutinol. </p>
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<p><strong>Reporting Adverse Drug Reactions to the SFDA</strong></p>
<p>The public and health professionals are encouraged to report adverse drug reactions to The National Pharmacovigilance Center on the Internet at .</p>
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