VIVA – FDA request a voluntary withdrawal of drugs for diabetes from Nostrum Laboratories the metformin type (two lots of 500 mg tablets and two lots of 750 mg tablets). On top of that, the company also withdrew metformin because it may contain N-nitrosodimethylamine (NDMA) above the acceptable dosage limit, triggering cancer.
Quoted from its official website, the FDA published a list of metformin withdrawn including details about which metformin products have been withdrawn. However, patients taking metformin retreats should continue taking it until a doctor or pharmacist provides them with a replacement or a different treatment option.
Because, it may be dangerous for type 2 diabetes patients to stop using their metformin without first talking to their health care professional. The FDA recommends that health care professionals continue to prescribe metformin when clinically as needed.
Quoted from page Trust Well, NDMA (N-nitrosodimethylamine) is a dangerous cancer-causing chemical that has recently been detected in several drugs. Water and many foods may contain low levels of NDMA but these levels are usually not high enough to cause damage.
But recently the Food and Drug Administration (FDA) found NDMA in levels that were higher than those recommended for some drugs. Several drugs, such as Zantac (ranitidine), an antacid, have been withdrawn.
Meanwhile, some drugs, such as valsartan, a drug used to treat high blood pressure and, in some cases, heart failure, and metformin, a drug for type 2 diabetes, are being further tested for these ingredients. However, the FDA continues to request a recall of these products.
It should be understood, NDMA is an organic chemical. It is a yellow liquid and has no smell. Although not intentionally produced in the US, except for research purposes, NDMA is created as a byproduct of various manufacturing processes and naturally through chemical reactions. For example, a process involving naturally occurring alkylamines and man-made compounds found in the environment can produce NDMA via chemical reactions.
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