Valisure Challenges FDA's Claims on Metformin's Safety
The U.S. Food and Drug Administration recently tested the oral diabetes medicine metformin for the presence of N-Nitrosodimethylamine (NDMA), a potent carcinogen, and in February, it published its results. Those tests showed that NDMA was either not detectable or only found at acceptably low levels.
But online pharmacy Valisure has conducted its own tests on 38 batches, and said that in 16 of them, it found NDMA levels above the 96 nanograms that the FDA deems an acceptable daily intake. In some batches, Valisure found NDMA in quantities more than 10 times that limit.
Of the 22 companies in total whose metformin drugs it tested, Valisure found batches from 11 that were over the threshold, among them Amneal Pharmaceuticals (NYSE: AMRX). That healthcare company is coming off a disappointing year in which its revenue fell 2% compared to 2018. Its net loss of $362 million was also more than twice its 2018 loss of $170 million.
Source Fool.com
