If DMF were present in valsartan that also contained NDMA, that could exacerbate the cancer risks, according to Valisure. Its tests detected DMF in valsartan alone and in pills where it was combined with a blood-pressure drug called hydrochlorothiazide.
For every 8,000 people who took the highest dose of valsartan contaminated with NDMA, there would be one additional case of cancer, the FDA has estimated. In standalone and combined forms, valsartan has been a go-to therapy for cardiovascular issues for a generation.
Physicians’ Alarm
Some of the valsartan that was positive for DMF was on a list of medicines the FDA had earlier deemed safe to use amid the recalls, including drugs manufactured by Alembic Pharmaceuticals Ltd. and Macleods Pharmaceuticals Ltd., both based in India.
Alembic doesn’t use DMF in its manufacturing process, according to spokesman Ajay Desai, who said the contamination likely occurred during analysis. A representative for Macleods couldn’t be reached for comment.
According to the assessments that it has posted online, the FDA hasn’t yet screened valsartan that Valisure tested from Aurobindo Pharma Ltd., Lupin Ltd. and Novartis.
Representatives for Aurobindo and Lupin didn’t respond to requests for comment.
The agency’s testing is based on particular batches of drugs, said spokesman Kahn. “The FDA is committed to ensuring adequate and safe supply” of valsartan and other drugs, he said.
The FDA doesn’t regularly test pharmaceuticals, relying instead on companies to ensure that medicines work and are safe. In January, a Bloomberg News investigation detailed how some generic drugmakers ignored data showing their products didn’t meet U.S. standards.
In the wake of the recalls, the American Medical Association last week decided to assess over the next year whether more needs to be done to protect the U.S. drug supply, including possible independent testing.