FDA on Tuesday announced the drug manufacturer ScieGen Pharmaceuticals has voluntarily recalled certain lots of the blood pressure therapy Irbesartan, after agency officials found some of the tablets contained an impurity believed to cause cancer.
Irbesartan is used to treat high blood pressure and kidney disease. The latest action comes after FDA this summer recalled various medications commonly used to treat heart failure and high blood pressure, citing an impurity in the products that could cause cancer.
ScieGen Pharmaceuticals recalls Irbesartan
FDA said ScieGen Pharmaceuticals has recalled certain Irbesartan tablets because they contain the organic chemical N-nitrosodiethylamine (NDEA), which is an impurity the International Agency for Research on Cancer has classified as a probable human carcinogen. According to FDA, NDEA "occurs naturally in certain foods, drinking water, air pollution, and industrial processes."
FDA said it estimates only about 1% of Irbesartan pills are affected by the recall. The recall applies to Irbesartan tablets in doses of 75 mg, 150 mg, and 300 mg that were manufactured by ScieGen Pharmaceuticals. The manufacturer packaged the tablets in 30- and 90-count bottles and labeled them as products from Westminster Pharmaceuticals and Golden State Medical Supply.
Consumers can check whether their Irbesartan tablets are affected by the recall at FDA's Irbesartan recall page or by calling Westminster's Regulatory Affairs department. FDA advised patients who are affected by the recall to continue using their medication until they can connect with a pharmacist or physician to identify an alternative medication (Shoot, Fortune, 11/1; Shannon, USA Today, 11/2; WSOCTV, 11/1; Fitzgerald, Sun Herald, 11/2).
Medication reconciliation: What you're missing beneath the surface
Medication reconciliation is a key lever for reducing readmissions, improving transitions of care, and boosting patient and provider satisfaction—but many organizations struggle to get it right.
Learn five of the most common medication reconciliation missteps and how pharmacy can help.