The Medicines Authority recommends withdrawal from the market of products containing the local antibiotic use fusafungine (Locabiosol), used particularly in tonsillitis or sinusitis.
“In Portugal is marketed the Locabiosol medicine 125 micrograms solution for oral or nasal spray, indicated for the local treatment of the affections of the upper airways,” according to a note posted on Infarmed site – Authority medicine in Portugal.
the recommendation of withdrawal from the market comes after a security review of the risk Assessment Committee on Pharmacovigilance of the European regulator, which evaluated the risk of severe allergic reactions in patients using fusafungine , concluding that the drug’s benefits do not outweigh the risks.
However, this position will be subject to a final decision and, by then, the drugs remain for sale.
“the most severe allergic reactions occurred after the drug and included bronchospasm. Although these reactions are rare, can be fatal and measures are identified that could significantly minimize this risk,” adds the Medicines Authority in its statement of disclosure of the position of the European evaluation committee.
it was also examined the increase in bacterial resistance caused by fusafungine, completing the European Medicines Agency that there is insufficient evidence, but the risk can not be excluded.
according to the note Infarmed, it was concluded that the benefit-risk balance “of these medicines is negative for all approved indications in the European Union”, recommending “the withdrawal of the respective authorization in market. “
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