Just a few weeks after the U.S. Food and Drug Administration declared that they had not found unsafe levels of NDMA in the metformin drugs they tested, an online U.S. pharmaceutical company has come to a completely different conclusion. Now the company, Valisure, is urging regulators to issue recalls on the drug.
Valisure found high levels of NDMA in 16 batches of metformin made by 11 different drug companies. In one batch of metformin, made by the company Amneal Pharmaceuticals LLC, the levels of NDMA were a whopping 16 times higher than the acceptable level set by the FDA. This directly contrasts with the FDA’s findings, which included only trace amounts of NDMA in two samples and no detectable amount of NDMA in another eight samples.
NDMA, also known as N-Nitrosodimethylamine, is a naturally occurring substance that is often found in trace amounts in medications as well as in water and other sources, such as cured meats, dairy products, and vegetables. In amounts less than 96 nanograms per day, it is not considered harmful. However, the substance can also be created as a byproduct of industrial processes, and if it surpasses certain levels, it may be capable of causing cancer.
Metformin is the fourth most prescribed drug in the United States. It is used to treat people with type 2 diabetes and those who are at risk of developing type 2 diabetes. Its prevalence makes it vitally important that impurities like NDMA contamination are caught and controlled before they have negative effects on the thousands of people who take them.
Valisure is now asking the FDA to recall the contaminated drugs and begin investigating what went wrong with those products. A spokesperson for the FDA said that the organization will be responding directly to Valisure promptly. It will also continue to monitor the issue and provide updates to the public on any recalls.
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Pharmaceutical companies and regulators around the world are still investigating the issue of NDMA contamination. Metformin has been recalled in Singapore and Canada, and blood-pressure medication valsartan and heartburn drug ranitidine have also been recalled in the U.S. for NDMA contamination. Only time will tell whether metformin recalls will also be seen in the U.S.
For the time being, people who take metformin on a regular basis should NOT discontinue the drug without speaking to their doctor. The health risks associated with discontinuing a metformin regimen are often greater than the risks associated with continuing to take a drug that may contain NDMA.Whizzco