Boxes of anti-anxiety drug recalled in France over incorrect leaflet

Instructions inside boxes of Alprazolam made by KRKA France laboratory recommend a maximum daily dose that is considerably too high

20 October 2021

Pharmacists have been asked to contact patients using the medicine “using any means at their disposal” Pic: Ninnaka / Shutterstock

By Joanna York

Boxes of the anti-anxiety drug Alprazolam produced by the KRKA France laboratory are being recalled in France due to incorrect instructions for use inside the box.

In affected boxes, there is an error in the maximum recommended daily dosage for treating anxiety in the third column of the instruction leaflet.

The instructions incorrectly state that patients may take up to four grams, instead of four milligrams of the medication, per day.

The incorrect sentence should read: “Recommended dose: your doctor can increase your dosage if necessary up to a maximum of 4mg per day, divided into multiple doses during the day.”

In a statement, l'Agence nationale de sécurité du médicament (Ansm) said that “all stock of Alprazolam HCS 0.25mg and 0.5mg in pill form currently on the market” produced by the laboratory was being recalled.

Alprazolam is one of the most prescribed tranquilisers in France and KRKA has a small share of sales of the drug in France. The drug is best known as Xanax, the name under which the Pfizer laboratories markets it, but the molecule is now in the public domain and produced as a generic by laboratories such as KRKA.

Alprazolam is only available on prescription and no problems have so far been reported due to this leaflet error. 

The Ansm asks pharmacists to contact patients who may have been given the medicine “using all means at their disposal” in order to provide them with an exchange for an equivalent generic version of the drug of their choosing.

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