The Food and Drug Administration (FDA) has issued a recall of a common medicine after lab tests indicated that 33 batches of it contained a possible carcinogen. The metformin tablets are routinely prescribed in the UK and are also sold in the US. The batches included the environmental pollutant N-Nitrosodimethylamine (NDMA), which is linked to cancer. According to the NHS:
Metformin is a medicine used to treat type 2 diabetes and to help prevent type 2 diabetes if you are at risk of developing it.
Metformin is a generic medicine that works to lower insulin levels in the blood and is used by diabetics worldwide. It is also thought to affect metabolic and cellular processes linked to age-related diseases including inflammation. After a contaminant was discovered following a series of tests, batches of the medicine were voluntarily recalled in the United States.
Based on a series of laboratory tests, NDMA has been categorised as a probable human carcinogen. It is a yellow, odourless liquid substance that is used to produce rocket fuel. It is also an environmental contaminant that can be found in water and foods like meat, dairy, and vegetables. NDMA is basically a by-product of various manufacturing processes including water chlorination.
Metformin was recalled after a possible carcinogen was discovered in 33 samples of the regularly prescribed drug. Cadila Healthcare Limited made the contaminated tablets in India, while Viona distributed them in the United States. In response to the discovery, Viona Pharmaceuticals voluntarily recalled batches of its metformin hydrochloride extended-release 750 mg tablets, which are packaged in 100-count bottles. According to the FDA, the bottles' expiration dates range from June 2022 to March 2023.
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The health watchdog has advised patients to continue to take their medications and seek advice from their doctors about alternate therapies. There have been no reports of disease or death related to the recall. The FDA earlier announced in December 2019 that NDMA may be found in metformin products in countries outside of the United States, necessitating an investigation.
After agency lab testing revealed inadequate amounts of NDMA, the FDA urged at least six businesses to voluntarily recall lots of extended-release metformin between May and November 2020. The announcement comes as the FDA issues a second recall for Nitroglycerin Lingual Spray, which is used to treat pain caused by coronary artery disease in patients.