Other safety alerts
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| European Union: PRAC recommends that fusafungine nose and mouth sprays are no longer marketed |
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The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that the marketing authorisation for fusafungine-containing medicines be revoked, so the medicines can no longer be marketed in the EU. This follows a review by the PRAC which concluded that the benefits of fusafungine did not outweigh its risks, particularly the risk of serious allergic reactions. Fusafungine is an antibiotic and anti-inflammatory nose and mouth spray used to treat upper airway infections such as rhinopharyngitis (common cold).
The majority of the serious allergic reactions occurred soon after the use of the medicine and involved bronchospasm (excessive and prolonged contractions of the airway muscles leading to difficulty breathing). Although the PRAC review found that serious allergic reactions are rare, they can be life-threatening, and the PRAC considered that no measures had been identified to sufficiently reduce this risk.
With regard to the benefits, the PRAC considered that the evidence for beneficial effects of fusafungine is weak. Taking into account the mild and self-limited nature of upper airway diseases such as rhinopharyngitis the PRAC considered that the benefits of fusafungine did not outweigh the risks.
The PRAC therefore concluded that the benefit-risk balance for fusafungine-containing medicines is negative for all currently authorised uses and recommended that their marketing authorisation be revoked in the EU.
The PRAC recommendation will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for the adoption of EMA final opinion.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002469.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, the above product is not a registered pharmaceutical product, and there is no registered product containing fusafungine.
Ends/ Saturday, February 13, 2016
Issued at HKT 12:00
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