According to an online news report posted on swissinfo.ch, millions of blood pressure tablets were recalled due to contamination with a probable carcinogen. As the U.S. Food and Drug Administration and pharmaceutical companies work on solving that issue, another hazardous chemical has been discovered in the same medications. The newly discovered contaminants are called azido impurities. According to regulatory authorities, azido impurities are mutagenic, which can change the user’s DNA and increase cancer risks.
The azido impurities were discovered in blood pressure medications that were recalled in the United States, Canada, and Europe. U.S. officials initiated the recalls due to N-Nitrosodimethylamine (NDMA) contamination, but U.S. regulators have not recalled medications with azido impurities.
So far, U.S. Food and Drug Administration inspectors have discovered at least one major pharmaceutical manufacturer in India has flawed processes for testing for the impurities and preventing the impurities during manufacture. Hetero Labs Ltd. was identified in documents reviewed by Bloomberg as a manufacturer that hasn’t made certain that any residue of impurities is not accumulating on its manufacturing equipment. This residue cross-contaminates subsequent batches, according to the internal documents.
The FDA inspector visited Hetero Labs Ltd.’s production plant that produces valsartan, an active ingredient for blood pressure drugs. This active ingredient is then sold to several pharmaceutical companies to create a finished tablet. This recent report states that Valsartan production can also create azido impurities. The news report states that the company did not answer requests for comment concerning the new findings.
Health Canada drug regulators declared a recall of valsartan last May due to elevated levels of azido impurities. The agency also recalled losartan and irbesartan since the drugs are in the same class of drugs as valsartan, and they were recalled for identical impurities.
Hetero’s Sangareddy district production plant is one of the company’s ten Indian facilities that is registered with the FDA to manufacture medications marketed in the United States. The plant was last inspected back in 2018, and it received the FDA’s worst rating. This could cause the FDA to deny approval of any new drugs manufactured at the plant until the company resolves the issues. The FDA usually permits companies with several violations to continue making medication they are already permitted to make at substandard plants as they correct their issues.
According to the news report, the documents also show that a particular substance used in the early phase of the drug-making process creates the azido impurities. The FDA’s documents report that Hetero’s production guidelines ask for maintaining that substance at a certain level to avoid forming dangerous impurity levels. The company’s internal study used to decide what the “safe level” should be was faulty.
FDA spokesman Jeremy Kahn stated that he could not comment on whether the agency was going to take action against Hetero.
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