Paris (AFP)

Benign sore throat tablets containing alpha-amylase, such as Maxilase, should no longer be freely available in pharmacies because of the risk of sometimes severe allergies, according to the ANSM Medicines Agency. .

The agency has informed the two laboratories holding marketing authorizations (MA) of these drugs, Sanofi and Top Pharm, its willingness to remove them from free access, told AFP Dr. Jean-Michel Race, a director of drugs at the ANSM. Pharmacists were notified by mail in June of this precautionary measure.

Allergic reactions occur mainly in the skin (hives and itching ...), but can also very rarely manifest as a drop in blood pressure, breathing difficulties alone or accompanied by swelling of the face (anaphylactic shock ).

Two cases of these serious shocks affected young people: in 2013, a 9-year-old child who had taken syrup containing this substance and in 2017, a teenager who took tablets. Added to this is the death in 2017 of an adult in his fifties who had also taken pills, details Dr. Race.

9.5 million boxes (syrups or tablets) based on alpha-amylase were sold in 2017.

The syrups, more frequently used in children, were not directly accessible but placed behind the counter of the pharmacist, notes he.

Very soon, the public will not be able to use the tablets directly but will have to address the pharmacist to obtain them as for the syrups.

The pharmacist can thus discourage the use of these drugs (syrups or tablets) in case of asthma or allergies. He will be able to steer on other means, not medicated, like drinking a lot of water, taking sweet things (sucking sweet candies, taking honey ...), because it is not a drug that will shorten the sore throat, says Dr. Race.

The independent journal Prescrire listed these alpha-amylase-based products (Maxilase and others), no more effective than placebo, in the latest version of its list of 105 drugs "more dangerous than useful" that can be pass, published Thursday.

The serious risk is in the leaflet for consumers and that for health professionals since 2018, according to the ANSM.

The products concerned (syrups and tablets) are Maxilase Alpha-Amylase throat pain from Sanofi and Top Pharma products operated by the Pierre Fabre and Biogaran laboratories: Alfa-amylase Biogaran and Alfa-amylase Top Pharm by Pierre Fabre (ex-Drill) .

© 2019 AFP