Health Canada Issues Recall Of Valsartan, Losartan & Irbesartan

Health Canada Issues Recall Of Valsartan, Losartan & Irbesartan

Introduction

Health Canada has announced a recall of most of the versions of valsartan , irbesartan, and losartan as the tests claimed that the drugs have exceeded the limit of azido impurity.

The health officials stated that multiple lots of valsartan, irbesartan, and losartan might contain mutagen and higher exposure to it can cause cancer.

The recalled products are sartan-based medications, which are angiotensin receptor blockers (ARBs) that help the blood to flow easily by relaxing the blood vessels. It helps to prevent heart attacks and stroke among patients with high blood pressure. Patients who have suffered from a heart attack or heart failure can also be treated with this medication.

The recall notice provided by Health Canada states that the products contain excessive levels of azido impurities that are known to mutate the DNA of a cell. The order even notified that as per the international guidelines, the mutagenic impurities have to be kept at a specific level as over-exposure to mutagen can increase the risk of cancer.

The officials have instructed the patients to consult their healthcare professional or pharmacist before continuing the medications as sudden cessation of the medication could cause serious health consequences among the users.

Most of the U.S. supply for the generic version of Diovan was impacted in July 2018, when U.S. Food and Drug Administration (FDA) issued a valsartan recall. Even certain versions of losartan and irbesartan were recalled as the studies concluding that the products contain a potent human carcinogen known as N-nitrosodimethylamine (NDMA).

Currently, there are hundreds of valsartan lawsuits pending in the U.S. court system with similar allegations that NDMA exposure has resulted in stomach cancer, liver cancer, esophageal cancer, prostate cancer, pancreatic cancer, and other injuries among the users.

An MDL has been formed of all the lawsuits overlooked by U.S. District Judge Robert B. Kugler in the District of New Jersey for coordinated discovery and findings.