Based on the results of the assessment of the Periodic Benefit-Risk Evaluation Report (PBRER) for fenspiride dated 05.11.2018, which was approved by the EMA Committee for Medicinal Products for Human Use (CHMP) on 21.11.2018, the company Les Laboratoires Servier, France, has undertaken to conduct a study on the proarrhythmic potential of fenspiride.
Cases of heart rhythm problems had previously been reported during the use of this medicine. To investigate a potential link between fenspiride and heart rhythm disorders, animal studies were conducted, according to which fenspiride is capable of prolonging the QT interval.
In view of the emergence of new safety data on fenspiride, the National Agency for the Safety of Medicines and Health Products of France (ANSM) announced on 08.02.2019 its decision to suspend the Marketing Authorization of medicinal products containing fenspiride (ERESPAL®), together with the recall of the medicinal products.
ANSM initiated an urgent referral procedure (Article 107i of Directive 2001/83/EC) with discussion at the next meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) (11-14.02.2019).
15.02.2019 PRAC recommended suspending the use of fenspiride medicines in Europe due to a potential risk of heart rhythm problems.
Fenspiride medicinal products are used in children and adults to relieve cough associated with lung diseases.
The suspension is a precautionary measure to protect patients while PRAC reviews the risk of QT interval prolongation and ventricular tachycardia (abnormalities of the heart’s electrical activity that can lead to cardiac rhythm disorders).
PRAC will now review all available evidence and make recommendations on the actions to be taken regarding marketing authorizations for medicinal products containing fenspiride in the EU. After the review is completed, the European Medicines Agency (EMA) will provide additional information and updated guidance to patients and healthcare professionals.
Currently, PRAC recommends that applicants communicate the following information to patients and healthcare professionals:
Information for patients
- Safety data indicate that cough medicines containing fenspiride may cause sudden serious heart rhythm disorders.
- While the available evidence is being reviewed, patients are advised to stop taking these medicinal products.
- The risk of cardiac rhythm disorders is observed only during the use of fenspiride.
- If you are taking cough medicines containing fenspiride, consult your doctor for recommendations on alternative treatment, if necessary.
- If you have any questions about the medicinal product you are taking, consult your doctor.
Information for healthcare professionals
- As a precautionary measure, while this matter is under review, healthcare professionals are recommended to advise their patients to stop taking fenspiride.
- The suspension of medicinal products containing fenspiride is related to the results of preclinical studies (a standard in vitro model of animal studies, inhibition of hERG channels), which showed that fenspiride could potentially lead to an increase in QT intervals in humans. These data supported the suspected link between fenspiride and QT interval prolongation/the occurrence of ventricular tachycardia in humans.
- Taking into account the indications for prescribing fenspiride (only for symptomatic treatment) and the seriousness of the danger of QT interval prolongation, the use of these medicinal products is temporarily suspended pending the results of the safety review.
- Further information will be provided, as necessary, to healthcare professionals after completion of the review.
After the review is completed, PRAC will send its recommendations to the EMA Committee for Medicinal Products for Human Use (CHMP), which will express the final opinion of the EMA.
LLC “Servier Ukraine” reported its appeal of 11.02.2019 to the Ministry of Health of Ukraine regarding the cancellation of the registration certificate and the subsequent withdrawal from the market of the company's medicinal products containing fenspiride (ERESPAL®). The procedure for withdrawing medicinal products from the pharmaceutical market is initiated by the company's decision in accordance with the legislation of Ukraine.
Link:
https://www.ema.europa.eu/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-suspension-fenspiride-medicines-due_en.pdf
