In the affected boxes there is an error in the maximum recommended daily dose to treat anxiety in the third column of the instruction leaflet.
The instructions incorrectly state that patients can take up to four grams, instead of four milligrams of the drug, per day.
The incorrect sentence should read: “Recommended Dose: Your doctor may increase your dose if necessary to a maximum of 4 mg per day, divided into several doses during the day.” “
In a statement, the National Medicines Safety Agency (Ansm) indicated that “all the stock of Alprazolam HCS 0.25 mg and 0.5 mg in tablet form currently on the market” produced by the laboratory was subject of a reminder.
Alprazolam is one of the most prescribed tranquilizers in France and KRKA holds a small share of sales of the drug in France. The drug is better known under the name Xanax, the name under which Pfizer laboratories market it, but the molecule is now in the public domain and produced as a generic by laboratories like KRKA.
Alprazolam is only available with a prescription and no problems have been reported so far due to this leaflet error.
The Ansm asks pharmacists to contact patients who have received the drug “by all means at their disposal” in order to offer them an exchange for an equivalent generic version of the drug of their choice.
Panorama of the French health system in 2021
Alternative medicine alert after two deaths in France