The mistake is small, but it can have serious consequences.
Boxes of alprazolam, a tranquilizer drug, are being recalled by their manufacturer because of a leaflet error which suggests that the maximum dose is much higher than reality, the French drug authority announced on Tuesday.
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"A recall of all batches of Alprazolam HCS 0.25 mg and 0.5 mg, (in) tablet, currently on the market is carried out by the Krka laboratory", detailed in a press release the National Security Agency of drug (ANSM).
Alprazolam is one of the most prescribed tranquilizers in France.
It is best known as Xanax, the name under which the giant Pfizer markets it, but the molecule is now in the public domain and produced as a generic by laboratories like Krka.
If he is forced to recall all his boxes of alprazolam, it is because he made a mistake in the instructions.
4 grams instead of 4 milligrams
It is written that the patient's doctor can increase his daily dose up to 4 grams per day when in reality it is a maximum of 4 milligrams.
However, if the recommended dose is exceeded, the consequences can go as far as a coma, as the ANSM reminds us.
However, this puts the seriousness of the situation into perspective by noting that alprazolam is only available on prescription, that no problem has yet been reported because of this error in the instructions and that Krka only presents 'a very small proportion of sales of this drug in France.
In any case, "Alprazolam HCS tablets do not present any defect and this recall is carried out only because of an anomaly in the leaflet", insists the authority.