The drug agency fears a risk of involuntary overdose in the consumer.
A drug commonly prescribed to lower cholesterol is recalling in French pharmacies, the National Agency for Medicines (ANSM) announces in a press release. This preventive withdrawal follows a packaging error which could lead to confusion between two different dosages and expose the patient to an involuntary overdose.
More precisely, “A limited number” Boxes supposed to contain the 10 mg/40 mg version of the treatment were wrongly labeled with the packaging of the 10 mg/80 mg version, can be read on the reminder of the ANSM. The content inside the box remains in accordance with the 10/40 mg dosage (tablets, blister, QR code), but the error on the case could mislead patients or health professionals. The batch concerned carries the beg10124b reference, with an expiration date in October 2026.
This treatment is used in patients with hypercholesterolemia. This is the association Ezetimibe/Atorvastatin, marketed by the Zydus France laboratory in the form of a box of 90 film -coated tablets with dosages 10 mg/40mg and 10 mg/80 mg (CIP: 34009 302 850 8 4). Several thousand patients receive this association each year in France each year, combining two active ingredients: Ezetimibe (which reduces the absorption of cholesterol at the intestinal level) and atorvastatin (which reduces the production of cholesterol by the liver). According to the latest data from the drug observatory, around 1,300 patients are treated each year with these dosages precisely, therefore potentially affected by this recall.
The laboratory specifies that no incident linked to this defect has been reported to date. In the meantime, the patients concerned are invited to check their box and not to change their treatment without medical advice. If in doubt, it is recommended to contact your pharmacist or doctor. Health professionals have received information via the usual pharmacovigilance channels. This reminder, although limited, recalls the importance of vigilance around chronic treatments.
