Some boxes of alprazolam, a tranquilizer, are being recalled by their manufacturer due to an error in the instructions that suggests that the maximum dose is much higher than reality, the French drug authority announced Tuesday.
“The withdrawal of all the batches of Alprazolam HCS 0.25 mg and 0.5 mg, (in) tablets, currently on the market is carried out by the Krka laboratory,” the National Drug Safety Agency detailed in a press release. (ANSM).
Alprazolam is one of the most prescribed tranquilizers in France. It is better known as Xanax, the name under which the giant Pfizer markets it, but the molecule is now in the public domain and is produced as a generic by laboratories such as Krka.
If you are forced to remove all your boxes of alprazolam, it is because you made a mistake in the instructions.
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 reach coma, as the ANSM reminds us.
However, this puts the seriousness of the situation into perspective by noting that alprazolam is only available by prescription, that no problems have yet been reported due to this error in the instructions, and that Krka only has’ a very small proportion of sales of this drug in France.
In any case, “the Alprazolam HCS tablets do not present any defect and this withdrawal is made solely due to an anomaly in the package insert,” insists the authority.
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