The US Food and Drug Administration has announced a recall of several batches of a blood pressure medication over concerns that it may contain high levels of a cancer-causing impurity.
Lupin Pharmaceuticals is voluntarily recalling several batches of two drugs: Irbesartan tablets as well as its Irbesartan and Hydrochlorothiazide tablets. The recall comes after an analysis found that certain batches of both medications had exceeded safe levels of the impurity N-nitrosoirbesartan, which is a probable human carcinogen—meaning it could cause cancer.
The FDA says that "out of an abundance of caution," the company is recalling all batches of Irbesartan tablets USP 75mg, 150mg, and 300mg, and Irbesartan and Hydrochlorothiazide tablets USP 150mg/12.5mg and 300mg/12.5mg.
The recall comes on the heels of reports the company received of people becoming ill after taking the medication. From October 8, 2018 through September 30, 2021, Lupin was notified about four cases of illness from Irbesartan, though no reports of people becoming sick from Irbesartan and Hydrochlorothiazide were received, per the FDA. It's not clear if the cases involved people who developed cancer or another illness.
Irbesartan tablet USP is designed to treat high blood pressure, to lower blood pressure, and to treat diabetic nephropathy in patients with high blood pressure who also have type 2 diabetes. Irbesartan and Hydrochlorothiazide tablet USP is a combination of irbesartan and hydrochlorothiazide, a type of diuretic that's used for high blood pressure in patients who need more than one medication to control their blood pressure, the FDA explains.
The FDA provided a full list of the recalled lots.
"The problem is the irbesartan component," Jamie Alan, PharmD, PhD, associate professor of pharmacology and toxicology at Michigan State University, tells Health. Irbesartan works by blocking a compound in the body called angiotensin, which raises blood pressure, Alan explains.
If you're currently taking this medication, the FDA recommends that you continue to do so but contact your health care provider about alternatives.
"Patients taking, Irbesartan Tablets USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment," the FDA stated.
Why does the FDA advise that you continue to take the meds, even if they are subject to a recall? The reason, Jamie Alan explains, is that you don't want to suddenly go off blood pressure medication if you need it. "If you stop taking the medication, your blood pressure could go up, raising your risk of stroke and other bad consequences," Alan says.
Just make sure you contact your health care provider ASAP, who can offer guidance that may involve switching you to a different blood pressure medication which functions the same way, says Alan.
As for the N-nitrosoirbesartan impurity, Alan urges people not to panic. "The overall risk is fairly low, and cancer is a very complex disease," she explains. "The risk of cancer is complicated by many things including genetics, environment, diet, and more. I would not panic, but I would call your doctor."
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