According to the U.S. Food and Drug Administration, we came to know that the medicines of blood pressure contain the third potential carcinogen which can affect one’s health adversely. Hetero Labs Ltd which is an Indian based company discovered the NMBA. The medicine of blood pressure contains losartan, and this impurity is known as N-Nitroso-N-methyl-4-aminobutyric acid and also know as an animal carcinogen.
Eighty-seven of the losartan medicines were taken and recalled in the United States, and it is claimed that they have impurities. In July this report and investigation have been started, and many medicines of blood pressure and heart failure were recalled to check the impurities and if they have some human carcinogen. FDA says that “overall, the risk to individual patients is very low,” but the agency added that those findings don’t diminish the significance of this issue and that it continues to evaluate the risks posed to patients.
Dr. Gottlieb said, “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. That said, any presence of such impurities in drug products is not acceptable. Over the past few months, the FDA has conducted a major investigation and has worked with drug companies to address the presence of impurities in these products.”
He added, “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. FDA scientists have developed novel and sophisticated testing methods specifically designed to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in ARB medicines. Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA,”