Home / france / batches of irbesartan recalled after discovery of impurity

batches of irbesartan recalled after discovery of impurity



After valsartan, irbesartan, another antihypertensive agent, is influenced by the recall of batches due to the presence of a substance classified as likely to be carcinogenic.

After valsartan, irbesartan, another medication for high blood pressure, is affected by recalls from parties due to the presence of an impurity classified as a probable carcinogen, the Friday drug agency said.

Valsartan and Irbesartan belong to the same family of drugs, the sartans. Since the summer, the valsartan, then occupied by 1.4 million French, has experienced a wave of recall campaigns due to the presence of two substances classified by the World Health Organization (WHO), the NDMA, as likely carcinogens. and NDEA. These successive recalls resulted in "supply tensions" and "stockouts".

WHO classifies a substance as "probably carcinogenic" if there is any doubt about its carcinogenicity, but there is no evidence to support or deny it.

As a reminder, the WHO classifies a substance as "probably carcinogenic" if there is any doubt about its carcinogenicity, but there is no evidence to support or deny it. Gherkins – and in general any vegetables stored in vinegar and fire fighting are also classified by WHO in this category. The risk of cancer is therefore only hypothetical at this stage.

»READ ALSO – Valsartan is defective: European Medicines Agency fears cancer

Do not interrupt your treatment abruptly

At European level, following the discovery of these undesirable substances in valsartan, the analyzes were extended to four other medicinal products: irbesartan, candesartan, losartan and olmesartan, these substances being produced by a process similar to that of valsartan.

The manufacturer of irbesartan, the Arrow Generics laboratory, has therefore checked many medicines. This showed the presence of NDEA at rates above the limits of the European Medicines Agency, hence the "recall of non-compliant parties", according to the agency in a statement. The recall of the lots took place on Thursday 10 January.

Controls are still being carried out on sartan-based drugs already on the market and likely to be affected by the presence of NDEA or NDMA. It is not excluded that other sartans may be the subject of future party recall, says the ANSM.

"However, the potential presence of NDMA and NDEA does not induce acute risk to the health of patients," the ANSM emphasizes. "The risk of abrupt discontinuation of treatment that is important (hypertensive attacks, heart defects, neurological accidents), patients should in no case interrupt their treatment without medical advice", adds the ANSM, which was established in July a green information number (0800 97 14 03).

"The risk of abrupt discontinuation of treatment is important, patients should under no circumstances interrupt their treatment without medical advice"

ANSM

READ ALSO – Palpitations: when do you care?

Alternatives available

Patients can check with a pharmacist if their box is irbesartan. If that is the case, the pharmacist gives them a box to replace them. Information on sartan-based medicines is available on the agency's website. In addition, there are many therapeutic alternatives for valsartan to support patients, according to the latter. In addition, the medicines agency has asked laboratories to market marketing products based on Sartan that have not been affected by the lack of quality to intensify their production.

Patients who take valsartan can also check with the pharmacist whether their medication is affected by the lack of quality. If this is the case, the office is reminded that the patient is asked to consult his doctor to adjust the treatment without stopping it himself. If there is no consultation, the pharmacist can give another medicine after consultation with the doctor.

In France, valsartan memories were organized in July, August, September, November and December 2018. Two Chinese companies (Zhejiang Huahai Pharmaceuticals, Zhejiang Tianyu Pharm.) And three Indian laboratories (Mylan laboratories limited in Hyderabad, Heterolabs, Aurobindo Pharma) manufacturer of the active ingredient was fixed in this case.

To ensure the quality of the medicines, the controls are no longer on the tablets but further ahead of the production process: "It has been decided at European level that the inspections in NDEA and NDMA must be carried out directly on the raw materials before all production of medicines based on sartans is effective from January 1, 2019, "says ANSM.

ANSM

Source link