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The National Medicines Safety Agency (ANSM) announced that an impurity had been found in some of these antihypertensives. Faced with the supply tensions that this recall induces, she explains to patients the procedure to follow.
Used in the treatment of arterial hypertension or even heart failure, some losartan-based drugs may be missing until early 2022. Alone or in combination with hydrochlorothiazide, they indeed face supply tensions after the detection of a “new impurity”In several batches which leads to their recall, said the National Agency for the Safety of Medicines and Health Products (ANSM) in a press release published on October 27.
Recall of losartan: a potentially mutagenic impurity
Evolupharm, Arrow generics, Biogaran… Several laboratories are concerned by “the presence of this impurity”Which is currently the subject of investigations at European level“to determine if this impurity is mutagenic or not”, That is to say capable of causing mutations in DNA. While waiting for the results, which should happen “in the coming weeks“, Laboratories “blocked the distribution of the affected lots”.
Reminder of losartan: what to do next
The ANSM explains that this recall has been carried out “as a preventive measure”And that he“does not exist no immediate risk associated with the presence of this impurity”. That is why she advises patients to do not stop their treatment without medical advice, “the risks in the event of sudden discontinuation of treatment” being “real”(Hypertensive outbreaks, destabilization of cardiovascular disease).
For those who need to renew their prescription, if their treatment is no longer available, the pharmacist can give them directly another medicine from the sartan family, without having to go through their doctor first. This replacement will nevertheless be carried out “on an exceptional and temporary basis, until the next medical consultation”. Pharmacists have a dose equivalence table in order to suggest the appropriate specialty.
Recall of losartan: affected batches
Here is currently the list of batches of losartan-based medicines affected by the recall (regularly update by ANSM):
- Evolupharm Laboratory (04/11/2021)
- Zentiva France Laboratory (03/11/2021)
- Eurogenerics Laboratory (03/11/2021)
- Zydus Laboratory (02/11/2021)
- Laboratory Arrow generics (02/11/2021)
- Mylan Laboratory (10/29/2021)
- Cristers Laboratory (10/29/2021)
- Sandoz Laboratory (10/28/2021)
- Biogaran Laboratory (10/28/2021)
- Téva Laboratory (10/27/2021)
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