Another medication used to treat hypertension is being recalled after it was found to be contaminated with a suspected cancer-causing agent, the Food and Drug Administration (FDA) announced in a Safety Communication. Manufacturer ScieGen is recalling certain lots of the heart drug irbesartan. Affected products have printed on their labels the words “Westminster Pharmaceuticals” and “GSMS Inc.”
The announcement comes on the heels of a recall of several lots of the high blood pressure and heart failure medication valsartan. Both irbesartan and valsartan are in a class of heart drugs called angiotensin II receptor blockers, or ARBs. And both were found to contain a substance known as N-Nitrosodiethylamine or NDEA.
NDEA is an organic chemical byproduct of manufacturing some pesticide and processing fish, and can unintentionally make its way into manufacturing through certain chemical reactions.
Several – but not all – drugs that contain valsartan were found to contain NDEA since July and were recalled. The agency had linked the recall to China-based drug maker Zhejiang Huahai Pharmaceuticals. The agency inspected the facility and put the drug maker on import alert at the end of September. This prompted the FDA to investigate all ARBs for these impurities.
Aurobindo is the manufacturer of the Irbesartan for ScieGen. Aurobindo is also recalling all unexpired lots of Irbesartan it supplied to the United States that are contaminated with NDEA. The recall affects about 1 percent of Irbesartan products on the market.
The FDA said patients should continue to take their medication as directed and to discuss any concerns with their doctor or pharmacist before changing medication. The agency also said that it believes the cancer risk with either Irbesartan or valsartan is low, but some medications may have been contaminated with NDMA for as much as four years.
FDA Recall Notice