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FDA investigating if carcinogen NDMA is in diabetes drug

pharmafile | December 6, 2019 | News story | Medical Communications FDA, Health Canada, MDMA, NDMA, carcinogen, diabetes 

The FDA is looking into if the diabetes drug metformin has unsafe levels of a cancer-causing chemical.

This comes after the agency investigated a range of drugs to see if they contained carcinogens, with the drug Zantac, a popular heartburn medication, being recalled for fear it contained N-nitrosodimethylamine (NDMA).

Metformin is a medication for type 2 diabetes and it helps control blood sugar. Its more notable branded names are Fortamet and Glucophage.

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The investigation of metformin in particular is due to other countries findings of low levels of NDMA in their metformin drugs.

Jane Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, said: “The FDA is investigating whether metformin in the US market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms.” She added that “the agency will recommend recalls as appropriate if high levels of NDMA are found.”

However, the FDA had downplayed fears, saying that the levels of contamination are similar to those found in foods like grilled or smoked meats.

Health Canada, Canada’s health regulator, said it would work with international partners on the issue. They have asked companies to test their metformin products and hand over samples for government testing. Currently they say they are not aware of any metformin products with NDMA levels that are above the limit.

Conor Kavanagh

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