There could be more harm than good in 2 potentially life-saving blood pressure drugs, according to the U.S. Food and Drug Administration (FDA). Irbesartan and hydrochlorothiazide tablets made by Lupin Pharmaceuticals are being voluntarily recalled due to concerns that they may contain high levels of impurities that can cause cancer.
Many batches of both blood pressure-lowering medications, were found to bear elevated levels of the impurity N-nitrosoirbesartan, which, according to laboratory testing, can cause cancer in humans. FDA data shows that nearly 90% of over 300 known N-nitroso compounds (including N-nitrosoirbesartan) were carcinogens based on animal studies.
“Out of an abundance of caution,” the FDA report reads, Lupin is recollecting all batches of Irbesartan tablets (including 75mg, 150mg, and 300 mg sizes in 30- and 90-count bottles) and all collections of the drug Irbesartan and Hydrochlorothiazide tablets (including 150mg/12.5mg and 300mg/12.5mg sizes in 30- and 90-count bottles) in the USA. On the FDA’s website, you can view the full list of recalled lot numbers.
It is advised that you continue taking your medication if it meets the recall criteria but you should contact your doctor for alternative treatment as soon as possible.
In addition to helping hypertensive patients with type 2 diabetes with diabetic nephropathy, Irbesartan tablet USP is used to help lower blood pressure and help people with hypertension. Even if you are not treated for high blood pressure, you should check your medicine cabinet for the medicine.
Based on FDA information, Lupin received four reports of illnesses related to Irbesartan between October 8, 2018, and September 30, 2021 (the earliest distribution date). None of these reports seem to be related to the issue. However, the two medications have been withdrawn from the market this year by the company.
According to the FDA, patients who are currently taking either drug should continue to take it since abruptly stopping it could be harmful to their health. In any case, they should contact their doctor immediately to discuss alternatives to conventional treatment. It is also recommended that retailers stop selling these drugs and send them back.