The United States Food and Drug Administration (FDA) is recalling irbesartan, a blood pressure medication, after finding contamination that could cause cancer.
In testing the drug, the FDA found the pills contain organic chemical N-nitrosodiethylamine (NDEA), which is classified as a probable human carcinogen. NDEA is used to make liquid rocket fuel and is a byproduct of fish processing as well as manufacturing certain pesticides.
The irbesartan tablets being recalled were manufactured in doses of 75 mg, 150 mg, and 300 mg by ScieGen Pharmaceuticals Inc. They are packed in 30- and 90-count bottles and labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc. The FDA urges consumers consult their physicians before discontinuing use of the tablets they have on hand, even if they believe their irbesartan pills may be part of the recall. Risk of harm to a patient’s health if they suddenly stop taking the drug may be higher, and a doctor should prescribe an alternative treatment before patients return the pills.
To see if you may have these hypertension pills in your possession, check this FDA irbesartan recall page for more information. You can also direct questions about the product to Westminster’s Regulatory Affairs department by phone at (888) 354-9939.
In June, the FDA also recalled valsartan, a heart medication that was also found to be contaminated with cancer-causing NDEA. Irbesartan is the first non-valsartan pharmaceutical the regulatory agency has found to contain the NDEA impurity.