Why was Locabiotal withdrawn from sale?

the Locabiotal 1% was a antibiotic and anti-inflammatory medicine used as a spray in the nose or throat marketed by laboratories servant to relieve the respiratory tract infections (nasopharyngitis, angina for example). Her marketing was stopped in France in 2005 due to the side effects of its active ingredient, the fusafungin. In 2016, theEuropean Union has decided in turn to remove the Locabiotal® of the sale estimating “that the benefits of fusafungin do not outweigh its risksin particular the risk of serious allergic reactions”. What were the directions Locabiotal? Why was it taken off the market? What to replace it with?

What were the indications for Locabiotal?

Locabiotal 1% (fusafungine) manufactured by the Servier laboratory receives marketing authorization (MA) the March 27, 1995. It is an antibiotic and an anti-inflammatory used in the form of a nasal and oral spray in the local adjunctive treatment of infections of the upper respiratory tract:

• nasopharyngitis (common cold)
• tonsillitis (inflammation of the tonsils)
• sinusitis (sinus infection)
• rhinitis (stuffy nose with discharge)
• laryngitis (inflammation of the larynx)

What are the causes of the withdrawal of Locabiotal?

► December 8, 2004. An opinion from the Transparency Commission of the Haute Autorité de Santé (HAS) estimates that Locabiotal 1% “is of no interest in terms of public health Given the Poorly established efficacy/adverse effects ratio of this proprietary medicinal product, the absence of usual gravity of the condition treated and the lack of place in the therapeutic strategy“. This specialty entails a risk of sensitization linked to the presence of fusafungine and can cause local irritation.

► July 19, 2005. Following the reassessment of medicines containing antibiotics and administered by the nose, throat or mouthwash, the National Agency for the Safety of Medicines (ANSM) concludes with the ineffectiveness of these drugs, including Locabiotal® (Fusafungine) in the treatment of nasopharyngitis, angina, oral infections or the prevention of their complications. “Topical antibiotic therapy has not demonstrated its ability to reduce symptoms or prevent complications from the pathologies targeted by these drugs. The antibiotics contained in these specialties are not useful in curing these infections which are mainly of viral origin and develop spontaneously favourably. The bacteria responsible for possible complications of these infections are not or poorly combated by the local antibiotics concerned“says the ANSM. In addition, the inappropriate use of antibiotics favors the appearance of resistant bacteria, in other words, it increases the risk of the body developing resistance to antibiotics which will no longer be effective in case of bacterial diseases. The risk-benefit balance of these proprietary medicinal products is considered to be unfavourable.

► September 30, 2005. The marketing of Locabiotal 1% is stopped in France at the request of theANSM.

► December 15, 2010a stopped of justice of the French government decides that Locabiotal 1% (fusafungine) is removed from the list of reimbursed drugs.

► March 12, 2012. A new specialty Locabiotal 0.25% solution for nasal or buccal spraying, no longer comprising fusafungine but peppermint essential oilis marketed in France by Servier laboratories.

► On April 1, 2016, the European Medicines Agency (EMA) withdraws the marketing authorization for all fusafungin-based spray medicines used in the treatment of respiratory tract infections, marketed outside France, including Locabiotal after having “concluded that the benefits of fusafungine did not outweigh its risks, in particular the risk of severe allergic reactions”.

► June 22, 2016the marketing authorization for Locabiotal 0.25% is canceled in France on request of Laboratoires Servier to avoid any risk of confusion due to the brand name with Locabiotal containing fusafungine. All lots are recalled.

What were the side effects of Locabiotal?

L’European Medicines Agency took note of the withdrawal of fusafungine sprayers after having “concluded that the benefits of fusafungine did not outweigh its risks, in particular the risk of severe allergic reactions”. These reactions involved bronchospasms (excessive and prolonged contractions of the muscles of the respiratory tract resulting in difficulty breathing). “Although the examination revealed that serious allergic reactions are rare, they can life-threatening and no measures have been identified to sufficiently reduce or manage this risk“argued the authority. Before sharing his “concerns about the potential of fusafungin to promote antibiotic resistance”.

What can I replace Locabiotal with?

There were no alternatives offered by the health authorities following the withdrawal of Locabiotal. In question, the “weak” evidence of its beneficial effects and “the benign and self-limiting nature of upper respiratory tract infections such as nasopharyngitis” for which it was indicated. In France, the ANSM also recalled that “angina, colds and nasopharyngitis are generally of viral origin. LAntibiotics are ineffective and therefore useless to cure them. To relieve yourself, you can use medicines intended to combat fever, pain and to reduce the troublesome manifestations of the disease. Sore throats that are caused by bacteria can be recognized by a quick test that the doctor performs during the consultation“.

Sources:

– Locabiotal 1%, solution for oral and nasal spray, Opinion of the Commission, HAS, 8 December 2004

– Information point on the withdrawal of topical antibiotics for the nose, throat and mouthwash, ANSM, July 2005

– Topical antibiotics for the nose, throat and in mouthwash: definitive cessation of marketing as of September 30, 2005, ANSM, July 19, 2005

– CMDh approves withdrawal of authorizations for fusafungine sprayers used in the treatment of respiratory tract infections, European Medicines Agency, 1 April 2016

– Fusafungin-containing medicinal products for oromucosal and nasal use, European Medicines Agency