December 06, 2019
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FDA assessing potentially harmful substance in metformin products

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Potential carcinogenic agents may be present in metformin based on reports from non-U.S. countries, which has prompted an investigation from the FDA, according to an agency statement.

The agent in question is N-Nitrosodimethylamine (NDMA), which is a nitrosamine. Food and water naturally contain some amount of this substance, according to Janet Woodcock, MD, director of the center for drug evaluation and research at the FDA, who noted that 96 nanograms is the “acceptable daily intake limit.” Current reports from non-U.S. countries have indicated that NDMA may be present in diabetes medications, although “within the range that is naturally occurring in some foods and in water.”

“The FDA is aware that some metformin diabetes medicines in other countries were reported to have low levels of NDMA,” Woodcock said in the statement. “The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms.”

It is at higher levels that “NDMA may increase the risk of cancer,” according to Woodcock. However, the FDA is not currently planning to recall metformin and the medication should still be taken and prescribed.

“The FDA recommends prescribers continue to use metformin when clinically appropriate, as the FDA investigation is still ongoing, and there are no alternative medications that treat this condition in the same way,” Woodcock wrote.

As Healio previously reported, due to evidence of NDMA, recalls of the angiotensin receptor blocker valsartan as well as generic forms of Zantac (ranitidine) have been initiated. - by Phil Neuffer