Nasal spray can cause severe hypersensitivity reactions
The pharmaceutical manufacturer Stada recalls its “Locabiosol” cold spray. The European Medicines Agency (EMA) withdrew the drug on May 28, 2016, because the active ingredient fusafungin can cause serious allergic reactions in an emergency. However, Stada and the French marketing authorization holder Servier do not want to exhaust the remaining weeks, but instead ask the pharmacists to take the products out of sale now.
European Medicines Agency withdraws approval on May 28
The over-the-counter cold medicine “Locabiosol” will no longer be available in pharmacies in the future. The active ingredient fusafungin contained therein was considered controversial for a long time, now the European Medicines Agency EMA has withdrawn the drug on May 28th. However, the French approval holder "Les Laboratoires Servier" and the German manufacturer Stada do not want to use the sell-off period. In a red hand letter, Servier therefore informs the specialist circles about the revocation of the authorizations for medicinal products containing fusafung within the EU and calls on the pharmacists to remove the affected products from the sale.
Severe allergic reactions possible
Fusafungin has an antibacterial and anti-inflammatory effect and has so far been used in the form of oral and nasal sprays for the local treatment of diseases of the upper respiratory tract such as sinusitis or runny nose. In Germany, the sprays were available without a prescription in the pharmacy under the name "Locabiosol®". A European risk assessment process was initiated in September 2015 due to increasing reports of severe allergic reactions in connection with medicinal products containing fusafung. The Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that health risks are much greater than the benefits and that approval should be withdrawn.
Accordingly, the active ingredient could lead to serious hypersensitivity reactions such as a spasm of the respiratory muscles (bronchospasm). Although these are rare, they are potentially life-threatening. In addition, the evidence of the benefits from the perspective of the PRAC is limited, according to the information from the license holder Servier. Since such a risk was not to be justified, the EMA finally decided to withdraw drugs with the active ingredient fusafungin from Europe.
No effect on infections caused by viruses
Years ago, the Stiftung Warentest had rated the product as "unsuitable". Because the antibiotic "Locabiosol" is directed against bacteria, it has no effect on the much more common virus-related inflammation in the nose and throat. According to the foundation's experts, there was also no evidence of a sufficient effect on bacterial infections, and there was also a risk of shortness of breath. (No)