EU Panel Backs Market Withdrawal of Fenspiride Due to Heart Risk

Troy Brown, RN

May 17, 2019

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended revoking marketing authorizations for fenspiride medicines because of heart risks, preventing them from being sold in the European Union (EU), according to an agency news release.

The move follows the committee's review of the risk for serious and potentially fatal heart rhythm abnormalities and its confirmation that fenspiride medications could cause these problems in patients who use them.

"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," according to the EMA.

Medications with fenspiride are used to relieve cough in children and adults with lung diseases.

"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," the agency said.

In February, PRAC recommended an EU-wide suspension of fenspiride medicines as a precaution while the committee reviewed the risk for QT prolongation and torsades de pointes in patients taking them.

For its review, PRAC considered cases of QT prolongation and torsades de pointes in patients taking fenspiride medicines, laboratory results, data from published literature, and input from stakeholders.

Fenspiride medicines are all licensed at a national level; therefore, the PRAC's recommendation will be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures-Human, which will decide on its implementation. The CMDh is responsible for harmonizing safety standards for medicines authorized by way of national procedures in the EU, Iceland, Lichtenstein, and Norway.

Information for Healthcare Professionals

Healthcare professionals should stop prescribing fenspiride medicines and should advise their patients to stop taking them.

"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," the agency said.

Patient Information

Cough medicines containing fenspiride will no longer be available in the EU because data has found a risk for sudden, serious heart rhythm abnormalities. Individuals are advised to stop taking these medicines and contact their healthcare provider or pharmacist for direction regarding alternative treatments, if necessary. Patients should talk with their doctor or pharmacist if they have questions or concerns about their medicine.

Information about ingredients in the medicine is available in the package leaflet that comes with the medicine. The risk for heart rhythm problems from fenspiride is only increased while the medicines are being used.

Individuals are urged to return unused medications to their pharmacy so they can be disposed of properly.

In the EU, fenspiride medicines are available under various brand names (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал, and Сиресп).

The drug is not approved in the United States.

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