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these medicines be withdrawn throughout the EU.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.
1. More information about the review is available in a separate
question-and-answer-document:
click here.
2. Most clobutinol-containing medicines have already been removed from
the market because Boehringer Ingelheim decided to voluntarily
withdraw its clobutinol-containing medicines from all markets
worldwide following their suspension in Germany.
3. Clobutinol-containing medicines are available in the EU in Austria,
Belgium, the Czech Republic, Germany, Greece, Finland and France.
4. The review of clobutinol was conducted under Article 107 of the
Community code relating to medicinal products for human use (Directive
2001/83/EC). This type of procedure is initiated in cases where a
Member State withdraws, suspends or changes the marketing
authorisation of a nationally authorised medicine as a result of the
evaluation of safety data. It provides for a harmonised European
approach because the CHMP is asked to prepare an opinion on whether or
not the regulatory actions should be implemented throughout the
European Union.
emea.europa.eu