The U.S. Food and Drug Administration has found a third type of cancer-causing impurity leading to the recall of blood pressure medications.
Nearly 90 lots of Losartan potassium tablets made by Hetero Labs in India and distributed by Camber Pharmaceuticals were recalled Thursday due the discovery of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a probable carcinogen.
This is the first hypertension medication found to contain NMBA, but a handful of other recalls at the end of 2018 resulted from the potential contamination of N-Nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA)—two other potential carcinogens.
“Our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug’s active pharmaceutical ingredients,” said FDA Commissioner Scott Gottlieb, M.D., in a statement.
Gottlieb said the agency is “deeply concerned about the presence of a third nitrosamine impurity” in hypertension drugs and is working on “novel and sophisticated testing methods” to detect these impurities.
The FDA warns that consumers should contact their doctor before stopping any medication.
While a number of different hypertension medications have been recalled—including Losartan, Valsartan, Amlopidine, Irbesartan, and Hydrochlorothiazide—an FDA analysis of NDMA and NDEA in recalled Valsartan found that the overall risk to individual patients is very low. Although, the agency added, “this doesn’t diminish the significance of this issue or the FDA’s concerns.”
