The shocking case of metformin, a popular medicine for diabetes detected with carcinogen has surprised everyone. Metformin has been prescribed to maintain and regulate body sugar and it is the fourth most commonly recommended medicine for diabetic patients in USA.. Bloomberg has reported this case where Valisure, an online pharmacy has tested metformin.
Valisure said in its report that metformin has been contaminated with N-nitrosodimethylamine, commonly famous as NDMA which is a cancer-causing agent. This carcinogen was reported in 16 batches, obtained from 11 different drug companies.
The highest amount of NDMA was reported in a drug made by Amneal Pharmaceuticals. The report tells that this amount was 16 times higher than the daily acceptable limit.
Metformin is a common medicine that doctors prescribe to patients of diabetes type 2. It helps to control high blood sugar. Last December FDA, said that it would soon test all diabetic medicines for the potential presence of NDMA after it was diagnosed in a popular heartburn medicine. It also said that it might recall medicines if found contaminated.
FDA did test metformin recently but it cleared it for daily use. It is not clear why the FDA’s report is different from Valisure’s report.
Valisure is currently pressing regulators for recalling metformin and investigating how did this contamination happen. On the other side, the FDA has received a citizen’s petition yesterday requesting a recall.
Last year, metformin was recalled in Singapore and this month it was recalled in Canada. But currently, there is no such information in the USA regarding recalling metformin. FDA would still continue to monitor levels of NDMA inside this drug metformin and many other drugs.
Previously, N-Nitrosodimethylamine (NDMA) was detected in many other medicines such as blood pressure drugs called “valsartan” and a heartburn drug called “ranitidine” leading to their recall from the market. In lower amounts, NDMA has also been found in grilled meat products, dairy and several vegetables based eatables.
Janet Woodcock is a certified physician and works as a director at FDA’s Center for Drug Evaluation and Research. In December 2019, she said that;
“Everyone is exposed to some level of NDMA. The FDA and the international scientific community do not expect it to cause harm when ingested at low levels.”
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It is still not confirmed why do these two reports differ in their results. Valisure claims to follow all FDA’s protocol while conducting the tests for NDMA not only in metformin but also in other drugs. However, it only made a few changes to make it more precise.
David Light, is the founder and CEO of Valisure, in a statement, he said that FDA might have tested samples that were not from the general drug supply system. This NDMA contamination might have occurred because of any error made during the manufacturing process, storage or even the drug’s own functions.
Valisure doubts that this contamination has originated during the manufacturing process and there are chances that the drug itself has added up to this contamination. A statement made to Becker’s Hospital Review says that;
“The FDA knows that impurities in medicines are of great concern to patients and consumers who rely on safe and effective medicines approved by the FDA, and we are working with manufacturers and global regulators to provide clear and actionable information. We will continue to work with drug manufacturers to ensure safe, effective, and high-quality drugs for the American public,”