URPL announces the withdrawal of marketing authorizations for medicinal products containing fenspiride due to the risk of life-threatening cardiac arrhythmias.After a review of data from the entire European Union, it was found that fenspiride prolongs the QT interval, which carries the risk of life-threatening cardiac dysrhythmia.
Given that these medicinal products are used to treat mild symptoms, no appropriate measures have been identified to minimize this risk. Therefore, the benefit-risk ratio of drugs containing fenspiride is negative.
Marketing authorizations for these medicines will be revoked within the EU and these products will no longer be available on the market.
Professional health care professionals should no longer advise patients on medicines containing fenspiride and should inform patients about discontinuation of therapy with these drugs and recommend alternative means of treatment, if necessary.
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