Two potentially lifesaving blood-pressure drugs could be causing more harm than good, according to a recall notice posted by the U.S. Food and Drug Administration (FDA). Lupin Pharmaceuticals announced a voluntary recall of all of its Irbesartan tablets and Irbesartan and Hydrochlorothiazide tablets, many of which could contain high levels of a cancer-causing impurity.
The recall was issued last week after testing revealed that several batches of both medications, which are used to lower blood pressure, exceeded acceptable levels of the impurity N-nitrosoirbesartan, a probable human carcinogen—meaning it could cause cancer, based on laboratory testing, the FDA explains. More than 90% of the over 300 known N-nitroso compounds (one of which is N-nitrosoirbesartan) were found to be carcinogenic when tested on animals, per the FDA.
“Out of an abundance of caution,” the FDA notice reads, Lupin is recalling all batches of Irbesartan tablets (including 75mg, 150mg and300 mg sizes in 30- and 90-count bottles) and all batches of the drug Irbesartan and Hydrochlorothiazide tablets (including 150mg/12.5mg and 300mg/12.5mg sizes in 30- and 90-count bottles) in the United States. The full list of recalled lot numbers is available at the FDA’s site.
If your medication fits the recall criteria, you're advised to keep taking it but should contact your doctor to seek alternative treatment as soon as possible. The Irbesartan tablet USP is an angiotensin II receptor blocker, used to help treat hypertension, lower blood pressure, help diabetic nephropathy in hypertensive patients with type 2 diabetes, among other uses. So be sure to check your medicine cabinet for the medication even if you're not being treated for blood pressure regulation.
Between October 8, 2018 (the earliest date the affected tablets were distributed) and September 30, 2021, Lupin received four reports of illness from Irbesartan and zero from Irbesartan and Hydrochlorothiazide; none “appear to relate to this issue,” per the FDA. The company stopped marketing both medications early this year.
Patients currently taking either medication are advised by the FDA to continue using them, since suddenly quitting them could have adverse health consequences. But, they should contact their doctor as soon as possible to discuss alternative treatment. Retailers are also advised to stop selling the drugs and return them as soon as possible.
Consumers can call 855-769-3988 or 855-769-3989 with questions.
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