ADR that result in revision of patient information
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| European Union: Withdrawal of marketing authorisations for fenspiride medicines |
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European Medicines Agency (EMA) announces that, on 16 May 2019, EMA’s safety committee (PRAC) recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU. This follows a review that confirmed that these cough medicines could cause heart rhythm problems. The 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.
The PRAC recommendation was adopted by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) by consensus on 29 May 2019 and will be implemented directly at national level.
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.
- Patients should stop taking these medicines and contact their doctor or pharmacist for advice on alternative treatments, if needed. They can check the ingredients of their 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 they have any concerns about their medicine, discuss them with their doctor or pharmacist.
- Return unused medicines to their 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.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/withdrawal-marketing-authorisations-fenspiride-medicines-0
In Hong Kong, there is one registered pharmaceutical product containing fenspiride, namely Fenspiride Tab 40mg “P.L.” (HK-59766). The product is registered by Julius Chen & Co (HK) Ltd, and is classified as a non-poison. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to fenspiride. Related news was previously issued by EMA, and was posted on the Drug Office website on 16 Feb 2019 and 18 May 2019. Letters to inform local healthcare professionals were issued by the DH on 18 Feb 2019. In light of the above EMA’s announcement, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, May 30, 2019
Issued at HKT 15:00
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