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ScieGen's angiotensin II receptor blocker (ARB) is a carcinogenic protein that has been detected during the testing, and the FDA warned in a MedWatch Safety Alert.
Westminster Pharmaceuticals and Golden State Medical Supply. The FDA provided a number of articles to the subject of the voluntary recall, which affects 1% of irbesartan in the U.S., according to the agency.
N-Nitrosodiethylamine (NDEA), a "probable" human carcinogen according to the International Agency for Research on Cancer. One area where the compound occurs 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 to return their irbesartan tablets, the FDA suggested. Moreover, they should not stop taking irbesartan until they find an alternative, "the risk of harm to a patient may be higher if the treatment is stopped immediately."
This is the second ARB discovered to contain 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 ARBs for the presence of impurities and has been reported by the United States." ARBs for the unexpected NDMA and NDEA impurities, "the agency noted.
2018-10-31T14: 30: 00-0400
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