Hypertension: The French Medicines Agency Recalls Batches of Drugs Based on Irbesartan

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Batches of drugs containing Irbesartan have been recalled

A month and a half after the Valsartan drug recall, irbesartan is also being recalled by the French Medicines Agency on Friday, January 11th. The presence of two substances classified as “carcinogenic” is the cause.

After valsartan , another anti hypertensive drug is affected by batch recalls because of the presence of a substance classified as a probable carcinogen, the Arrow Generics laboratory’s irbesartan, the Medicines Agency said Friday.

The recall of the lots concerned, organised Thursday, is the first recall batches of drugs of the family of sartans, other than valsartan, says the ANSM drug Agency.

Since the summer, valsartan, which then took 1.4 million patients, has suffered a wave of recalls due to the presence of two substances classified as “probable carcinogen” by the World Health Organisation (WHO), NDMA and NDEA. These successive recalls resulted in “supply tensions” and “stockouts” .

“Non-compliant” lots

The Arrow laboratory conducted controls on batches of irbesartan-based drugs that found NDEA at levels above acceptable limits, resulting in “recall of non-compliant lots ,  the agency notes. communicated.

Controls continue to be carried out on sartan-based medicinal products already on the market and likely to be affected by the presence of NDEA or NDMA.

However, “the potential presence of NDMA and NDEA does not induce acute risk to the health of patients,” insists the ANSM.

A toll free number 0800 97 14 03

“The risk of abrupt cessation of treatment being important (hypertensive attacks, cardiac decompensations, neurological accidents), patients must not under any circumstances interrupt their treatment without medical advice” , adds the ANSM, which set up in July a green information number (0800 97 14 03).

Patients, without interrupting their treatment, can check with a pharmacist if their box of irbesartan is concerned. If so, the pharmacist will give them a box to replace it.

Information about sartan-based medicines available is on the agency website. In addition, many therapeutic alternatives to valsartan exist to support patients, according to the latter. In addition, the first laboratories intensified their production of sartan-based medicines or alternatives, at the request of the ANSM.

Patients on valsartan can also check with the pharmacist if their medication is affected by the quality defect. If this is the case, the agency recalls, without stopping the treatment, the patient can urgently consult his doctor to adapt the treatment. If there is no consultation, the pharmacist can deliver another medicine after having a consultation with the doctor.

European analyses extended to other drugs

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

At European level, after the discovery of these undesirable substances in the valsartan, the analyses were extended to four other angiotensin II receptor antagonists, irbesartan, candesartan, losartan and olmesartan, these substances are manufactured in a process similar to that of valsartan.

On the other hand, to ensure the quality of medicines, the controls are no longer on tablets but further upstream of the manufacturing process: “It was decided at European level that NDEA and NDMA controls should be conducted directly. on raw materials before any production of sartan-based medicinal products, as of 1 January 2019, “ says ANSM

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