The agency is specifically testing metformin, a generic drug commonly used to treat patients when initially diagnosed with Type 2 diabetes. The agency is testing for N-nitrosodimethylamine, also known as NDMA, a potentially cancer-causing impurity that is formed during some drug manufacturing processes.
Metformin is the active ingredient in Bristol-Myers Squibb’s Glucophage, Sandoz’s Etform, Teva Pharmaceutical’s Metformax and Berlin-Chemie’s Siofor, according to Bloomberg.
The European Medicines Agency is also testing its metformin products, and health officials in Singapore recalled three versions of metformin marketed there after finding levels of NDMA above the acceptable level.
The FDA said patients taking metformin should continue use while testing occurs and that the agency will recommend recalls as appropriate.
Read the full article here.
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