The FDA has asked five drugmakers to voluntarily recall their metformin products after it found unacceptable levels of a carcinogen in the drug, The Wall Street Journal reported.
The agency said May 28 that after months of testing, it found unacceptable levels of N-nitrosodimethylamine, or NDMA, a cancer-causing chemical when ingested at high levels, in extended-release versions of metformin.
Metformin is used by millions of Americans to treat Type 2 diabetes and sold under brands including Fortamet, Glucophage, Glumetza and Riomet.
Apotex and Amneal Pharmaceuticals have both recalled their extended-release tablets after being asked to do so by the FDA. An FDA spokesperson declined to tell the Journal which other drugmakers were asked to recall their metformin products because they haven't formally filed a recall action.
The FDA told the Journal it didn't ask drugmakers that sell a large percentage of extended-release metformin in the U.S. to recall their products, but to test their products for NDMA and not release any batches if the chemical is above acceptable levels.
The agency also told the Journal that it is assessing whether any of the recalls would cause shortages and is working with manufacturers to limit the effects of any potential shortages.
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