U.S Food and Drug Administration revealed levels of nitrosamine impurity N-Nitrosodimethylamine (NDMA) above acceptable intake limit in lots of extended –
Release(ER) formulation of metformin , a prescription used to control blood sugar in patients with type-2 diabetes .
USFDA is in contact with five firms to recommend they voluntarily recall their products ,
the health regulator said on Thursday , without mentioning their names .
“There are additional manufacturers of the metformin ER formulations.
The FDA is continuing to work closely with manufacturers to ensure appropriate testing”, a statement from the regulators said .
USFDA said it is also asking to all manufactures to first check out the level of NDMA before releasing them into US market.
Level above the acceptable limit ( 96 nano gram per day ) will not be release into market now .
According to USFDA , NDMA with continuous use for a long period of timeabove acceptable limit increase the chances of having cancer .
This investigation began because of some drugs for blood pressure and ARBs ( angiotensin II receptor blockers ) , heartburn medicines (ranitidine , nizatidine ) , as well as diabetic medicines metformin .
FDA said that patients should not stop medicines without first talking to their doctors .
According to data collected from the laboratories test done on metformin in the month of February .
NDMA found from ‘not detectable to low level. But in the month of may , according to announcement of Apotex, metformin found with NDMA levels in excess of the acceptable daily intake limit .
NDMA And It’s Causes
NDMA is N-Nitrosodimethylamine which is acceptable in daily limit with 96 nano-grams per day or 0.32 parts per million for ranitidine .
Drugs like omeprazole , esomeprazole, cimetidine , lansoprazole contains NDMA . It can contaminate drinking water and humans often get NDMA exposure from consuming foods or drink.
Exposure to NDMA in Valsartan can cause prostate cancer , lower esophageal cancer ,
Non Hodgkin lymphoma , leukemia , multiple myeloma , colon stomach intestinal or pancreatic cancer .
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