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PRECAUTION- A second antihypertensive drug of the sartan family is currently subject to batch recalls, announced Friday the Agence du médicament.
In question? Again, the presence of a substance clbadified as probable carcinogen. Details.
– The LCI Editor
It is not excluded that other drugs from the same family may be subject to future batch reminders.
After valsartan, a second antihypertensive drug is currently affected by batch recalls due to the presence of a substance clbadified as probable carcinogen, Announced Friday the Drug Agency.
This is the generic, irbesartan Arrow Génériques laboratory. Controls on batches of irbesartan-based drugs have found NDEA at levels above acceptable limits, resulting in the "recall of non-compliant lots," the agency said in a statement.
The patients concerned, without interrupting their treatment, can check with a pharmacist if their box of irbesartan is concerned. If it does, it will give them a box to replace it.
As their names indicate, valsartan and irbesartan belong to the same family of drugs, the sartans. Information about them is available on the agency's website, while controls continue to be carried out on these products.
"The potential presence of NDMA and NDEA does not induce acute risk to patients' health", insists however the ANSM, which set up as of July a green number of information (0800 97 14 03).
And to warn: "The risk of abrupt cessation of treatment being important (hypertensive outbreaks, cardiac decompensations, neurological accidents), patients should not under any circumstances interrupt their treatment without medical advice".
As a reminder, since the summer, valsartan, which then took 1.4 million patients, has suffered a wave of recalls due to the presence of two substances clbadified as probable carcinogen by the World Health Organization (WHO) , NDMA and NDEA.
After the discovery of these undesirable substances, the badyzes were extended at the European level, to four other sartans: irbesartan, candesartan, losartan and olmesartan, manufactured according to a process similar to that of valsartan.
On the other hand, to ensure the quality of drugs, controls are no longer on tablets but more upstream of the manufacturing process.
In recent months, successive recalls have resulted in "supply tensions" and "stockouts".
First laboratories have already intensified their production of sartan-based drugs or alternatives, at the request of the ANSM.
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