The U.S. Food and Drug Administration (FDA) has issued an alert that people taking the blood pressure medication, irbesartan, should contact their doctor immediately as ScieGen Pharmaceuticals Inc. is recalling certain lots of the drug with “Westminster Pharmaceuticals” and “GSMS Inc.” on the label due to possible contamination of a carcinogen used in the production of gasoline, as a byproduct of fish processing, and in the manufacturing of certain pesticides.
How do chemicals used in rocket fuel ever enter into the pill manufacturing process? NDEA and NDMA can be unintentionally introduced into manufacturing through certain chemical reactions.
Recalled tablets were manufactured in 75mg, 150mg and 300mg doses by ScieGen and are packed in 30 and 90-count bottles.
NDEA and NDMA
According to the National Institutes of Health (NIH), the recalled drugs contained N-Nitrosodiethylamine (NDEA), a “suspected human and animal carcinogen used in gasoline as a stabilizer for industry materials and as a lubricant additive.” A few months ago, the FDA announced a recall of another blood pressure medication, valsartan, due to contamination from NDEA and N-nitrosodimethylamine (NDMA).
NDEA is deadly if swallowed and can cause cancer. In studies, mice and rats have died after a dose of 40 grams of NDEA, and it’s corrosive to soft tissue in humans. Direct contact to NDEA may not produce an immediate response, but prolonged exposure can cause damage to the dermis.
Millions of the valsartan pills have been recalled over the last several months due to NDMA contamination (similar to NDEA), and the FDA urged people taking the drug to see their doctor immediately and to not stop taking the drug without advice from their doctor.
The same FDA alert now stands for irbesartan. While the risk of having a contaminated pill in your possession is unlikely, it is a possibility and therefore all people should follow the FDA’s direction.
One company in China, Zhejiang Huahai Pharmaceuticals, was found to have produced tainted pills, so the FDA placed this company on an import alert in September 2018; all active pharmaceutical products made by this company are not permitted to enter into the United States.
Irbesartan is an angiotensin II receptor blocker (ARB), a type of drug that blocks a potent chemical in the blood called angiotensin, which causes muscles surrounding blood vessels to contract from binding to the angiotensin II receptors. When angiotensin is not blocked and is able to bind, it narrows the vessels, which can then cause high blood pressure. Just as with valsartan, it’s crucial to contact your doctor before abruptly stopping irbesartan because of the dangers involved with doing so.
If you have taken this medication for hypertension, please check with your doctor and refer to the FDA recall page for more specific information. You can also direct questions to Westminster’s Regulatory Affairs Department at (888) 354-9939.