A pharmaceutical company has recalled a commonly-used diabetes drug after it found that the said drug contains high levels of a cancer-causing agent.
Marksans Pharma Limited issued a recall of its metformin hydrochloride extended-release tablets. They found that the drug contains high levels of N-Nitrosodimethylamine (NDMA), which is considered a probable carcinogen. They noted that it has a dose higher than the acceptable limit on a daily basis of 96 nanograms a day. The recall was published by the Food and Drug Administration (FDA) this week.
Metformin is a type of drug that treats type 2 diabetes. The drug is designed to lower patients' glucose levels. Those recalled were the ones sold under Time-Cap Labs, Inc. brand name. Drugs between 500-750 mg were the ones that were noted in the recall.
The recall expands the previous recall on the same drugs, which transpired during the summer. It is only one of the various metformin products, which were ascertained to contain NDMA. There were also seven more pharmaceutical companies that issued a similar recall on the metformin hydrochloride extended-release tablets because of their carcinogenic ingredients.
One thing that the FDA is keen on doing now is to find out the origin of NDMA and how it gets included in metformin drugs. It is something to ponder upon for the FDA because more often than not, the drugs that they have would have acceptable levels of NDMA in accordance with the guidelines set by the FDA. However, Marksans did not divulge the amount of NDMA found in the drug.
The risk statement on FDA's announcement underscored that NDMA is a known contaminant, which can be found in foods like dairy products and vegetables, as well as in the water. They also pointed out though that Marksans Pharma Limited has not yet received any report relating to the recall on any adverse effect of the drug.
The pharmaceutical company is already making efforts to notifying its distributors and customers. The company issued a press release and has also sent out notification letters with regards to the return or replacement of the recalled products. They also specified the affected lots, which must be recalled. The lot number is located on the bottle label's side panel.
The World Health Organization (WHO) reported that in 2014, there were already 422 million people suffering from diabetes. Low and middle income countries have seen a rise in diabetic cases. The disease is one of the major causes of blindness, heart attack, kidney failure, stroke, including lower limb amputation.