FDA again expands recall for blood pressure drug losartan

This is the fifth time the losartan recall has been expanded so far this year.

By Nicholas Sakelaris

Sept. 24 (UPI) -- The U.S. Food and Drug administration has expanded a recall for generic blood pressure medications due to possible contamination with a cancer-causing chemical, regulators said.

The expanded recall includes five new lots of the medication losartan, an angiotensin II receptor blocker used to treat hypertension.


The FDA said the added lots were developed by Torrent Pharmaceuticals Limited and include both losartan potassium and potassium/hydrochlorothiazide tablets.

The agency said the medications were found to contain traces of N-methylnitrosobutyric acid, or NMBA, which has been linked to cancer. The recall applies only to lots that contain levels of NMBA above FDA-allowable levels.

Monday was the fifth time the FDA has expanded the losartan recall, which was first announced in January. The agency, however, advised patients using losartan to continue the treatment.

"[T]he risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment," the agency said in a statement. "Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication."

The drug is also used to treat Left Ventricular Hypertrophy and nephropathy in Type 2 diabetic patients.


The FDA warned a year ago of impurities in Torrent Pharmaceuticals' valsartan drug products, which are also used to treat high blood pressure.

A study of more than 5,000 patients taking the drugs showed they were not more likely to develop cancer in the short term.

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