Blood Pressure Recall Losartan drugs again (Reports).
Torrent Pharmaceuticals Limited is the latest drug company to issue a recall of losartan potassium, a popular blood pressure drug that’s been under scrutiny for more than a year for containing probable human carcinogens.
The voluntary recall, announced by Torrent Sept. 23, affects three lots of losartan potassium tablets and two lots of losartan potassium/hydrochlorothiazide tablets. Losartan potassium is used to treat hypertension in patients with left ventricular hypertrophy or nephropathy in type 2 diabetics; potassium-hydrochlorothiazide tablets are indicated for use only in hypertensive patients with LV hypertrophy.
In its statement, Torrent said it issued the recall—the latest in a series of Torrent recalls that date back to December 2018—due to the detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) in six lots of its finished product. NMBA has been found in Torrent’s drugs before, including in 60 lots of losartan potassium tablets and 54 lots of losartan potassium/hydrochlorothiazide tablets back in March, and in other manufacturers’ products, including Vivimed Life Sciences and Teva Pharmaceuticals.
Recalls of angiotensin II receptor blockers (ARBs) like losartan, valsartan and irbesartan have been ongoing for months, and at the end of August the FDA said its investigation into the phenomenon revealed little actual risk with taking the drugs. Center for Drug Evaluation and Research Director Janet Woodcock, MD, said in a letter that if 8,000 people took the highest dose—320 mg—of N-Nitrosodimethylamine (NDMA)-tainted valsartan each day for four years, there might be one additional case of cancer over the lifetimes of those 8,000 people. That’s a risk of 0.01%, but Woodcock said the risk patients face is likely much smaller than that.
“As part of our efforts to be transparent with regarding impurities in ARBs, we want to make sure patients have a full understanding of how these impurities may affect them,” Woodcock wrote at the time. “Notably, we would like to stress that the actual risk to patients is likely much lower than our estimates, which reflect a scientific assessment of the highest possible exposure.”
Torrent’s affected losartan tablets were manufactured with active pharmaceutical ingredient (API) from Hetero Labs Limited, which has been implicated in several other ARB recalls. The FDA said it’s a snag in the drug manufacturing process that results in the formation of genotoxic impurities in a finished product.