March 4, 2019 — Camber Pharmaceuticals Inc. has recalled 87 lots of Losartan medications because it may contain a cancer-causing impurity.
The recall was issued after the FDA detected a third type of carcinogen — N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) — at dangerous levels.
The Losartan in the recalled medication was manufactured by Hetero Labs Ltd. in India.
In the ongoing saga of recalled blood pressure drugs, the FDA now believes that the carcinogens are generated in the manufacturing process — and specifically the reuse of materials, such as solvents.
The FDA has identified at least two other similar carcinogens in other types of recalled blood pressure drugs, including N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)
The FDA says “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.”
Losartan is a prescription medication that is used to treat high blood pressure and congestive heart failure.
The FDA will continue to update the list of products included in the recall as more information becomes available from ongoing testing. If patients take Losartan, Valsartan, or Irbesartan products, they should check the list periodically, as information may change.