Health Risks Much Higher Than Benefits For Colds with Fusafungin?

Cold Spray: Comes out for Fusafungin?
For cold sprays that contain fusafungin, could possibly come out. The approval for this should be revoked. Background is the increasing number of side effects reports. According to the experts, the risk of the application is higher than the benefit.

Severe allergic reactions
The German Federal Institute for Drugs and Medical Devices (BfArM) has announced in a press release that the European Medicines Agency (EMEA) Committee for Risk Assessment (PRAC) has recommended that the authorizations of fusafungine-containing nasal and oral sprays be revoked. Background is the increase in reported cases of severe allergic reactions in adults and children. The risk of using the drug is according to experts, higher than its benefits.

Nasal and oral sprays with fusafungin are increasingly critically evaluated due to the threat of side effects. (Image: fefufoto / fotolia.com)

For the treatment of infections and inflammation
Fusafungin has antibacterial and anti-inflammatory properties and is used in sprays for the local treatment of infections and inflammation of the nose and throat area. In Germany, these are available as oral and nasal sprays in pharmacies without a prescription under the name "Locabiosol®" and are approved for the treatment of acute inflammatory diseases of the upper respiratory tract. The risk assessment procedure was already initiated in September 2015. The PRAC concluded that although severe allergic reactions are rare, they can potentially be life-threatening. In the treatment of mild upper respiratory diseases such a risk is not responsible. The members of the committee were unable to identify any measures that would satisfactorily reduce this risk. Therefore, the experts recommend taking drugs with fusafungin throughout Europe from the market.

In Germany only one drug affected
Professor Martin Schulz, chairman of the German Pharmacists Committee of the German Pharmacists said: "In Germany, to our knowledge, only the drug Locabiosol® affected." He recommends that patients who want to use or buy the OTC drug in to get advice from the pharmacy. There are many alternatives available. Many health experts advise against such means anyway. Because some nasal sprays favor a stuffy nose even more.

Preparations will remain available
It is said that manufacturers of fusafungine-containing products can now request re-examination by the PRAC within 15 days. However, because such preparations are authorized at national level, the Mutual Recognition Coordination Group (CMDh) must first make a decision on the PRAC recommendation. If this is unanimous to the detriment of the active ingredient, the withdrawal is immediately binding for all member states. And in the case of a simple majority, the final decision is up to the EU Commission. Until then, however, the preparations remain available without restriction. (Ad)