FDA advises recall of diabetes drug metformin over carcinogen concerns
pharmafile | May 29, 2020 | News story | Medical Communications | Carcinogens, MDMA
The FDA has asked that multiple pharmaceutical companies recall the formulations of their diabetes drug metformin after the regulatory body found high levels of a possible carcinogen.
The FDA said that the extended release versions of the drug contained the carcinogen N-nitrosodimethylamine (NDMA) in a level that was beyond the acceptable limit of 96 nanograms.
The regulatory body has said that five companies who sell the formula have been contacted, and have named Canadian company Apotex Corp as one of the firms whose metformin tablets had high levels of NDMA.
However, the FDA says that type 2 diabetes patients taking the drug should continue to do so until their doctor can prescribe a replacement treatment.
NDMA is toxic to the liver and possibly causes cancers in the stomach and bladder. It is usually found in small quantities in alcohol, tobacco, cheese and cold meats.
This investigation began back in December after concerns were raised by the online pharmacy Valisure over NDMA contamination in ranitidine and metformin formulations. Valisure said back in March, that its independent tests showed high levels of metformin made by 11 companies. Their analysis of 38 batches found that 16 had traces of NDMA exceeding the FDA’s acceptable levels.
The results of this investigation come after the FDA launched a recall of the heartburn drug Zantac in April due to high levels of the same carcinogen.
Conor Kavanagh
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