Irbesartan may contain a substance classified as a probable carcinogen. The Arrow Generics laboratory recalls groups of this drug against hypertension, announced on Friday 11 January the National Agency for Drug Safety (ANSM).
As valsartan, which has suffered a wave of recalls since last summer, irbesartan belongs to the sartani family. It is not excluded that other sartani can be the object of calls for future lots, says ANSM. In question: the presence of two substances classified as probable carcinogens by the World Health Organization (WHO), NDMA and NDEA.
"No acute risk"
Arrow has conducted tests that have detected NDEA at levels above acceptable limits, notes the agency. Tests continue to be conducted on Sartan-based drugs already on the market. However, the potential presence of these substances "It does not induce an acute risk to patients' health", insists the ANSM.
"The risk of abrupt discontinuation of treatment is important (hypertensive attacks, heart failure, neurological accidents), patients should under no circumstances interrupt their treatment without medical advice", adds ANSM, which set up a toll-free number in July (0800 97 14 03).
Patients without interrupting their treatment can check with a pharmacist if it is their irbesartan box. If so, the pharmacist will give them a box to replace it.
Information on Sartan-based medicines available is on the Agency's website. In addition, many therapeutic alternatives to valsartan exist to support patients, according to the latter. In addition, the laboratories have intensified the production of drugs or alternatives based on Sartan, at the request of ANSM.
Chinese and Indian companies blocked
For France, two Chinese companies (Zhejiang Huahai Pharmaceuticals, Zhejiang Tianyu Pharm.) And three Indian women (Mylan Laboratories Limited in Hyderabad, Heterolabs, Aurobindo Pharma) that produce the active ingredient, have been blocked in this case.
At the European level, after the discovery of these undesirable substances in valsartan, the analyzes were extended to four other sartans: irbesartan, candesartan, losartan and olmesartan, these substances were 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 upstream: "It has been decided at the European level that controls in NDEA and NDMA should be conducted directly on raw materials before any production of Sartan-based medicines, starting from 1st January 2019 », says ANSM.