AIFA orders an immediate ban on the use specialita’ antifungal drug “ITRACONAZOLE”

The Italian Medicines Agency by order dated Aug. 4, 2016, has ordered the immediate nationwide prohibition of all lots of the medicinal specialty ITRACONAZOLE EG*8CPS 100MG – AIC 037080037 from the company Eg Spa. The measure became necessary, points out Giovanni D’Agata, president of the "Sportello dei Diritti," following the inspection by Aifa inspectors at the Cosmo production workshop, with particular reference to the detected deviation n. 26 concerning documentary deficiencies. EG company must ensure immediate communication of the ban to all recipients of the batch in question as soon as possible and in any case within 48 hours of receiving the ministerial order. L’itraconazole (trade name: Sporanox, Triasporin) is an antifungal drug that acts against a broad spectrum of fungi and fungi that can cause both superficial and systemic infections. For superficial mycoses, it is indicated against vulvovaginal candidiasis, onychomycosis, oral candidiasis and dermatophytosis.

Its systemic use targets aspergillosis, cryptococcosis, histoplasmosis, sporotrichosis, blastomycosis, and other related infections. Side effects: apart from the aforementioned mechanism of competition on membrane sterol synthesis with human cells, a cardiodepressant effect of itraconazole was demonstrated’itraconazole. In particular, there is a reduction in left ejection fraction, which has no particular symptoms, when the drug is administered intravenously.

There have been several clinical cases of heart failure and edema leading to heart failure’heart failure.