The online pharmacy, Valcury, has found another cancer-causing chemical in blood pressure pills made by companies, including Novartis, according to a petition to the US Food and Drug Administration.
FDA submission on Thursday includes dimethylformamide, DMF, a drug found in the heart of valsartan, according to Valisure. The pharmaceutical operation in New Haven, Connecticut requires the FDA to reduce the amount of DMF in medicines and to recall that valsartan has high levels of DMF. The year when chemical N-nitrosodimethylamine or NDMA was found in the Chinese version of valsartan as a drug that has been used for decades to treat hypertension.
In March, the FDA stated that the impurities found in the recovered medicines could have been the result of chemical reactions that occur in the production of drugs or the reuse of materials as solvents. will examine Valcur's findings, a spokesman for the agency said. Consumers should continue to take blood pressure medications, regardless of whether they have been withdrawn until they have consulted their doctor, according to the regulatory agency.
the risk that our scientists believe will be related to drug prolongation while the patient's physician or pharmacist does not provide a safe replacement or different treatment option, "the FDA spokesman said.
The FDA does not regularly check for pharmaceutical products, relying on manufacturers to make sure their products are safe and effective. Novartis, which makes Diovan, a trademark version of valsartan, said it usually does not use DMF in making medicines, and information from its vendors shows that they do not.
In this way, "Novartis can not currently exclude the possibility that traces of DMF (within the applicable limits) have been available in the materials of other drug suppliers," said a spokeswoman for the physician.