番茄社区

ScieGen's angiotensin II receptor blocker (ARB) irbesartan is under recall due to a carcinogenic impurity found during lab testing, the FDA warned in a .

Affected products are labeled as coming from Westminster Pharmaceuticals and Golden State Medical Supply. The FDA provided lot numbers of the products subject to the voluntary recall, which affects 1% of irbesartan in the U.S., according to the agency.

The trouble is that the irbesartan was found to contain N-Nitrosodiethylamine (NDEA), a "probable" human carcinogen according to the International Agency for Research on Cancer. One area where the compound occurs is in industrial processes.

There has been no NDEA found in the irbesartan from other companies.

Patients should contact a healthcare provider who can advise them about an alternative treatment prior to returning their irbesartan tablets, the FDA suggested. Moreover, they should not stop taking irbesartan until they find an alternative, as "the risk of harm to a patient's health may be higher if the treatment is stopped immediately."

This is the second ARB discovered to contain a possible cancer-causing impurity -- beginning in July, several valsartan products fell under recall when they were found to contain N-Nitrosodimethylamine (NDMA).

"FDA continues to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities," the agency noted.

Comment