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Published on 24 October 2007

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EMEA recommends clobutinol withdrawal

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The EMEA has recommended that marketing authorisations for cough medicines containing clobutinol should be withdrawn throughout the European Union (EU).

The organisation made the decision after it launched an investigation into the safety of the drug.

It concluded that the risks associated with the treatments are greater than their benefits, and as a result suggested that their authorisations should be withdrawn.

The investigation was launched in September after German health regulators suspended the marketing authorisations for the medicines because preliminary results of a study indicated that the use of clobutinol was linked to side-effects affecting the heart.

The Committee for Medicinal Products for Human Use (CHMP) reviewed the safety of the medicines in the light of Germany’s decision in a bid to decide if it should be implemented throughout the EU.

The CHMP concluded that the use of clobutinol is associated with a risk of prolongation of the QT interval, which can affect the heartbeat, and is known to be linked to fainting and disruption of the heart rhythm, especially when taken in higher doses.

And the CHMP said because clobutinol is used to treat a common complaint for which alternative treatments are available, the marketing authorisations of all clobutinol-containing medicines in the EU should be withdrawn.

Copyright © PA Business 2007

European Medicines Agency



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