New Carcinogens Found in Blood Pressure Medications, Recall Issued

More carcinogens have been discovered in blood pressure medications, which has prompted another recall by the U.S. Food and Drug Administration (FDA). On Friday, the FDA raised concerns about losartan potassium tablets sold by India-based Hetero Labs Ltd. and distributed by Camber Pharmaceuticals. The FDA said the medication used to treat high blood pressure and heart failure contained an impurity called N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), a known carcinogen. The FDA said this is the first angiotensin II receptor blocker (ARB) drug recall due to the presence of NMBA. This marks the third type of nitrosamine impurity detected in ARB medicines, the FDA said.
ARBs work by blocking a substance in the body known as angiotensin that causes blood vessels to tighten. As a result of its mechanism, ARBs relaxes blood vessels, which lowers blood pressure and increases the supply of blood and oxygen to the heart. According to the FDA, recent testing of the 87 lots of losartan tablets revealed levels of NMBA that are higher than the acceptable limits set by the FDA. The evaluation suggests that the nitrosamines found in ARBs may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API, and may also result from the reuse of materials, such as solvents, the FDA said.