All batches of the diuretic Furosemide 40mg from the Teva laboratory are now subject to a recall measure as a “precautionary measure”, the Medicines Agency announced on Monday evening.
“As a precautionary measure and to avoid any risk of confusion on the lot numbers concerned”, the National Medicines Safety Agency (Ansm) asked “all patients who have boxes of Furosemide Teva 40 mg to return them at their pharmacist ”. This decision follows the death of a 91-year-old man on Saturday evening after taking a diuretic for several days that could come from a poorly conditioned batch.
Indeed, following a packaging problem, “some tablets have been replaced by tablets of the sleeping pill Zopiclone also called Imovane”, indicated the Ansm in a previous press release.
This new measure also comes after the Agency received Monday morning two new pharmacovigilance reports (one death and one serious case). In this case, the incriminated drugs represent two batches of 95,000 boxes, or 190,000 boxes of drugs in total.
However, the Agency would like to point out that “it is not the characteristics of the drug which are in question but an industrial problem linked to the packaging of the drug, which has led to the replacement of the diuretic by a sleeping pill”.
Finally, in conjunction with the Agency, the Order of Pharmacists asked pharmacists to directly call all patients to whom they would have sold boxes of Furosemide Teva dosed at 40 mg. And the Ansm indicates that “health professionals must immediately report any adverse effect suspected of being due to a drug of which they are aware to the regional pharmacovigilance center on which they depend geographically”. Patients and approved patient associations can also report any adverse reactions to their regional pharmacovigilance center.
A toll-free number has been opened by Teva laboratories at the request of Ansm: 0800 51 34 11. It is open to the public 24 hours a day.
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