New impurities lurking in some heart medications

Over the past few years, blood pressure medications have been recalled due to concerns about N-nitrosodimethylamine (NDMA), a probable carcinogen. But this may not be the only impurity to be worried about in these medications. As drug companies have addressed the NDMA issue, they have also found new potentially dangerous chemicals known as azido impurities.

Regulatory authorities say azido impurities are mutagenic, indicating they can alter people’s DNA and potentially raise their cancer risk. Earlier this year, Canada and European countries asked drugmakers to recall certain heart medications after finding azido impurities; the United States has yet to do so.

According to documents, an FDA inspector found that at least one large India-based manufacturer, Hetero Labs Ltd., used a faulty system for controlling the impurities when the inspector visited Hetero’s India production plant in August 2021. The plant makes the active ingredient for the blood pressure medication valsartan. Health Canada announced recalls of valsartan, an ARB, in May 2021 for elevated levels of azido impurities.

Other drugs in the same class, losartan and irbesartan, were recalled as well over the past few months. Teva Pharmaceuticals recalled ARBs in the United Kingdom in June 2021, followed by Sanofi in August 2021, according to UK’s Medicines and Healthcare products Regulatory Agency.