Healthcare regulators have set their sights on type 2 diabetes drug metformin to see if it contains unsafe amounts of N-nitrosodimethylamine (NDMA).
The FDA is looking into the drug’s possible contamination with NDMA, a potential carcinogen, and has initiated an investigation, CDER Director Janet Woodcock said. Additionally, the EMA has reportedly asked drugmakers to test their products for the contamination.
Woodcock noted the agency’s improved testing methods enable the detection of trace amounts of impurities and said this could be why low levels of NDMA have been found.
“We know what to look for in products' chemical structure and manufacturing processes that may increase the risk of forming low levels of nitrosamines,” she said.
Singapore’s Health Sciences Authority recalled three metformin-based medicines after finding they had levels of NDMA, a potential carcinogen, that exceeded internationally accepted levels. The authority noted that the risk to patients taking the three medicines are “very low” because they have only been on the market since last year.