However, he has not received any communication official, if not "heard something, just a few days ago, from some scientific informants who, in proposing other sprays, advised against Locabiotal".
The TEST – Antonella Giordano – 29 March 2016
Is it possible that a drug that is about to be withdrawn from the market throughout Europe continues to be safely prescribed by doctors? Let's talk about Locabiotal, an oral spray based on fusafungine, which has been used for over 50 years in cases of laryngitis, tonsillitis and even simple colds. For some months the drug has been "under observation" for various allergic reactions, including serious ones, which have occurred immediately after use. It was precisely the Italian Medicines Agency that asked for an opinion to the EMA which recommended its withdrawal in all European countries for a more than valid reason: the health risks outweigh the benefits. France and Portugal have already moved in this direction.
But the Italian doctorsof all this they know nothing and they continue to treat Locabiotal as a harmless spray, to be prescribed when necessary, as they have done up to now. Is it normal that they have not received any communication informing them at least of an increase in cases of allergic reactions linked to the use of the drug?
The Test-Lifebuoy has verified it asking for an opinion directly from some general practitioners, specialized in allergy.
“THEY DIDN'T SAY ANYTHING TO US”
“Locabiotal? I prescribe it a lot and I have never heard of allergic reactions. By now the communications of Federfarma and Aifa are on the agenda and allergies are very widespread. Especially if you abuse a substance, it happens a bit like with peanuts!” This was the response of the first doctor consulted. Second rumor but same disinformation: a doctor explains to us that she prescribed the drug during the last winter season, while this year she hasn't prescribed it yet. However, he has not received any communication official, if not "heard something, just a few days ago, from some scientific informants who, in proposing other sprays, advised against Locabiotal".
Let's try one pediatrician which gives us a less inclined reaction towards the drug, but still open to it: “I've never prescribed it, but I haven't received any notice of withdrawal. And in any case, I always evaluate on a case-by-case basis; sometimes I also prescribed medicines that had been discouraged by Aifa because I felt it was necessary to do so. In this case I would say that an alternative can be found since it is not a life-saving drug”.
We continue to ask doctors and collect different answers. An allergist, for example, tells us: “I never prescribe it because if antibiotic therapy is needed, I prefer to prescribe a normal antibiotic and not Locabiotal which, being a local drug, I consider almost useless. But everyone chooses on the basis of their own experience”. Another doctor admitted that Locabiotal can cause this type of reaction (which he called annoyances!), but that these are rare events. And to the question: "Would you prescribe it?" he replied: “No, because they are old products, which no longer have a reason to exist”.
So why are there still doctors who continue to prescribe it a lot despite the EMA's Pharmacovigilance Risk Assessment Committee wrote black on white That the marketing authorization of fusafungine-containing medicines should be revoked so that the medicines can no longer be sold in the EU?
“ARE YOU JOKING? I WILL CONTINUE TO PRESCRIBE IT”
The icing on the cake comes from a general practitioner who did not want to listen to reason: “Locabiotal is perfect because it is both antibiotic and anti-inflammatory, and it doesn't create any problems. I don't know where you read all this, but these are things that can be said about any drug, for each excipient it contains. I could make you a list of a thousand medicines that should be withdrawn from the market, such as rinazine and rinocidine, which are performance-enhancing drugs and instead are easily sold in pharmacies as over-the-counter medicines".
That there are doping drugs on the market certainly does not reassure us. But in this case the point is another: doctors are the guardians of our health and should be the first recipients of important communications on the effects that a medicine can cause. But apparently communications are either not sent or not read!
The TEST – Antonella Giordan0 – 29 March 2016
AIFA. EMA communication on medicines containing fusafungine (12/02/2016)
THE
the Risk Assessment Committee for the Pharmacovigilance EMA's (PRAC) has recommended that the marketing authorization of fusafungine-containing medicines should be withdrawn so that the medicines can no longer be marketed in the EU.
This follows a review by the PRAC which concluded that fusafungine's benefits do not outweigh its risks, in particular the risk of serious allergic reactions. Fusafungine is an antibiotic and anti-inflammatory used as a spray by nose or mouth to treat upper respiratory tract infections such as nasopharyngitis (common cold).
The PRAC recommendation will now be forwarded to the Co-ordination Group for Mutual Recognition and Decentralized Procedures for Medicinal Products for Human Use (CMDh), which will adopt a final position.
Attached the EMA communication
For more information:
go to the EMA website http://www.ema.europa.eu/ema/
contact thePharmacovigilance Office
Related news: EMA communication on medicines containing fusafungine (12/02/2016)
