Medicines containing valsaratan, losartan and irbesartan, which were manufactured by various companies in different countries, have been taken out of the pharmacy's shelves since July, when chemicals have emerged as being carcinogenic. Recalls of these angiotensin II receptor blockers or ARBs continue to increase. The US Food and Drug Administration maintains a regularly updated list of recalled medicines.
In this case, this is not a callback. Instead, Valisure, an online pharmacy, tests "every batch of medication that is spent". In ongoing tests, which include FDA standard tests and some proprietary analysis technologies, the pharmacy found that N-dimethylformamide (DMF) is high in certain batches of the active substance valsartan. She shared these details with the FDA in a June 1
3 Citizens petition. She said she would do so to grab the FDA's attention and call on the authorities to act.
DMF is a solvent that may have liver damage, cancer and other causes, according to US Centers for the Control and Prevention of Diseases. It is used in chemical manufacturing and pharmaceutical production and is included in some textile pigments, dyes, printing materials, stripping solvents and coatings.
Jeremy Kahn, spokesman for the FDA, wrote in an e-mail that the FDA generally does not comment on third party research, but evaluates it as part of the evidence to further our understanding of a particular issue and our mission to help protect public health. "
" The FDA will examine citizen petitions and address them directly to the petitioner.
Kahn added that there are international standards on how much DMF is permitted in medicines and is classified as a Class 2 residual solvent with a permissible daily exposure of 8.8 milligrams per day.
"It's important note that the reported DMF levels are more than 100 elements lower than those specified by international standards as a worrying level for the patients, "said Kahn.
The drugs recalled by the FDA were containing several different contaminants Contaminated, including N-nitrosodimethylamine or NDMA, classified as a potential carcinogen by the US Environmental Protection Agency.