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31 May 2019

Case analysis: Can marketing authorization can be revoked?

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Yes. Marketing authorization can be revoked and it generally carried out, in case of safety issued observed with the molecule. Here is a latest case study on withdrawal of marketing authorization of already marketed formulation.

Case: EMA safety committee recommends to withdraw marketing authorisations for fenspiride medicines

  • The European Medicines Agency’s (EMA) safety committee (PRAC) recommended on May 16, 2019 that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU.
  • Reason: This follows a review that confirmed that these cough medicines could cause heart rhythm problems. The Pharmacovigilance Risk Assessment Committee (PRAC) considered all the available evidence in its review. This included cases of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that may lead to heart rhythm disturbances) in patients using these medicines, results of laboratory studies, data from published literature and stakeholder input.
  • Heart rhythm problems can be serious and occur suddenly, and it is not feasible to identify in advance the patients who may be at risk of these problems with fenspiride. In contrast, fenspiride medicines are used to treat non-serious cough. Therefore, the PRAC considered that these medicines should no longer be marketed.

In case of any withdrawal of marketing authorization, it is important that department should publish the notice and information should reach to patients and healthcare professionals. 

Information for patients: Cough medicines containing fenspiride will no longer be marketed in the EU because of data showing a risk of sudden, serious heart rhythm problems; You should stop taking these medicines and contact your doctor or pharmacist for advice on alternative treatments, if needed. You can check the ingredients of your medicine in the package leaflet accompanying the medicine; Patients are only at risk of heart rhythm problems with fenspiride while they are taking these medicines; If you have any concerns about your medicine, discuss them with your doctor or pharmacist; Return unused medicines to your pharmacy for appropriate disposal.

Information for healthcare professionals: Healthcare professionals should no longer prescribe fenspiride medicines and should advise their patients to stop taking fenspiride medicines; The withdrawal of the marketing authorisations of fenspiride medicines is based on case reports and nonclinical studies (including hERG channel binding) that showed that fenspiride can cause QT prolongation and has proarrhythmia potential (could cause triggering or worsening of arrhythmia) with the associated risk of torsades de pointes; Given the authorised uses of fenspiride for symptomatic treatment only and the seriousness of the safety concern, the benefit-risk balance of these medicines is negative for the currently authorised uses.

Fenspiride medicines are available as syrup or tablets and used in adults and children from the age of 2 years to relieve cough resulting from lung diseases. In the EU, fenspiride medicines have been authorised via national procedures in Bulgaria, France, Latvia, Lithuania, Poland, Portugal and Romania and are available under various brand names (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, etc).

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