Pharmaceutical manufacturer Stada is recalling its cold spray "Locabiosol".The European Medicines Agency( EMA) withdrew its approval as of May 28, 2016, as the active substance fusafungin can cause serious 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 Withdrawal May 28
The over-the-counter cold remedy "Locabiosol" will no longer be available from the pharmacy. The active substance fusafungin has long been considered controversial, now the European Medicines Agency( EMA) has withdrawn the approval on 28 May. 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 calls on the pharmacists to withdraw the affected funds from the sale.
Serious allergic reactions possible
Fusafungin has antibacterial and anti-inflammatory properties and has been used in the form of oral and nasal sprays for 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Assessment( PRAC) concluded that the health risks are much higher than the benefits and the authorization should be withdrawn.
Therefore, 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 perspective 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 rated the remedy as "unsuitable" years ago. Because the antibiotic "Locabiosol" is directed against bacteria, it has no effect on the much more common virus-related inflammation in the nasopharynx. Thus, even with bacterial infections, no sufficient effect can be demonstrated, moreover, there is a risk of an onset of respiratory distress, so the experts of the Foundation.(nr)