Azido impurities, chemicals that can change a person's DNA and potentially increase their cancer risk, have been found in some U.S. blood pressure drugs, Bloomberg reported Oct. 13.
In 2018, the FDA began asking drugmakers to recall blood pressure pills after finding unacceptable levels of N-nitrosodimethylamine, or NDMA, a chemical that can cause cancer when ingested at high level. This action led Canada and countries in Europe to do the same.
Now, Canada and European countries have begun asking drugmakers to recall the same heart drugs after finding azido impurities, though the U.S. has yet to pull the drugs.
The FDA found at least one large manufacturer, India-based Hetero Labs, has an inadeqaute process for controlling the inpurities, according to documents reviewed by Bloomberg. The documents said Hetero has not ensured that impurity residue isn't building up on manufacturing equipment, leading to potential for cross-contamination of subsequent drug batches.
Drugmakers implicated in Canada and Europe's 2021 azido impurity recalls include Sanofi, Teva and Novartis subsidiary Sandoz.