Drug companies expanded a recall of Losartan lots after detecting a third potentially cancer-causing impurity in blood pressure medication.
Camber Pharmaceuticals voluntarily recalled an additional 87 lots of Losartan potassium drugs used to treat high blood pressure and congestive heart failure Thursday.
The detection of trace amounts of a new potential human carcinogen, known as N-Nitroso-N-methyl-4-aminobutyric acid or NMBA, prompted the recall.
On Friday, Torrent Pharmaceuticals voluntarily recalled 60 lots of Losartan potassium tablets and 54 lots of Losartan potassium/hydrochlorothiazide, similarly over the detection of trace amounts of NMBA.
The recalled tablets from both companies were made by Hetero Labs in India.
Each company noted it has not received any reports of adverse events related the recall.
Previous recalls of Losartan and other angiotensin II receptor blockers, ARB medicines, such as Valsartan and Irbesertan have included two other possible carcinogens, such as N-nitrosodimethylamine or NDMA, and N-nitrosodiethylamine or NDEA.
Certain lots of blood pressure and heart failure medications have been recalled from various companies worldwide since the U.S. Food and Drug Administration in July recalled valsartan medicines manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals after detecting NDMA.
Recent federal research has found NDMA and NDEA’s “risk to individual patients is very low,” a U.S. Food and Drug Administration statement said.
“We are deeply concerned about the presence of a third nitrosamine impurity in certain ARB medications, but it’s important to underscore that, based on the FDA’s initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure,” FDA Commissioner Scott Gottlieb said in the statement.