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NDMA 2 articles

Recalls cause shortage of high blood pressure drugs

Sweeping recalls of a class of high blood pressure drugs known as ARBs, or angiotensin II receptor blockers, has resulted in a shortage, Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb and FDA director of drug evaluation and research Dr. Janet Woodcock said in a joint statement. And the problem will probably get worse. The shortage is among ARBs that contain the active drug ingredient valsartan, and may soon also affect other ARBs that contain losartan and irbesartan. The shortage is due to recalls of the drug over an unexpected impurity, which was identified as a chemical called NDMA ... Read More

High levels of cancer-causing impurity found in heart drug valsartan

Levels of a carcinogenic impurity found in several brands of the high blood pressure and heart failure drugs containing the active ingredient valsartan are up to more than 2.5 times higher than what is considered “reasonably safe for human ingestion based on lifetime exposure,” according to a Food and Drug Administration (FDA) news release. The agency reported earlier that the impurity may have been present in some of the drugs for as long as four years. The impurity is called N-nitrosodimethylamine or NDMA. For reference, the FDA says that consuming up to 0.096 micrograms (mcg) of NDMA per day is ... Read More