Health risks Stada recalls known cold spray Locabiosol

Nasal spray can lead to severe hypersensitivity reactions
The pharmaceutical manufacturer Stada calls back his cold spray "Locabiosol". The European Medicines Agency (EMA) withdrew its approval as of May 28, 2016, as the active substance fusafungin can trigger severe allergic reactions in an emergency. However, Stada and the French license holder Servier do not want to exhaust the remaining weeks but urge the pharmacists to take the products out of the sale now.

European Medicines Agency withdraws approval on 28 May
The over-the-counter cold remedy "Locabiosol" will no longer be available in pharmacies in the future. The active ingredient fusafungin has long been considered controversial, now the European Medicines Agency (EMA) has withdrawn the approval for May 28. But the French license 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 medical community about the withdrawal of the marketing authorization for fusafungin-containing medicines within the EU and urges the pharmacists to withdraw the affected funds from the sale.

European Medicines Agency sees more risks than benefits with the cold spray "Locabiosol". (Image: matthias21 / fotolia.com)

Serious allergic reactions possible
Fusafungin has an antibacterial and anti-inflammatory effect and has been used in the form of oral and nasal sprays for the local treatment of upper respiratory tract disorders such as sinusitis or runny nose. In Germany, the sprays were available without prescription in the pharmacy under the name "Locabiosol®". In September 2015, a European risk assessment procedure had been initiated due to increasing reports of severe allergic reactions related to fusafungine-containing medicines. In doing so, the European Medicines Agency (EMA) Committee on Risk Assessment (PRAC) concluded that the health risks are much higher than the benefits and the authorization should be withdrawn.

Accordingly, it could come through the drug 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 proof of benefit from the point of view of the PRAC is limited, according to the information of the license holder Servier. Since such a risk was not responsible, the EMA finally decided to withdraw drugs with the active ingredient fusafungin Europe-wide from the market.

No effect on infections by viruses
The Stiftung Warentest had already rated the product years ago 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 experts of the foundation, bacterial infections can not be demonstrated to have a sufficient effect. Moreover, there is a risk of respiratory distress onset. (No)