
After months of testing, the Food and Drug Administration reported finding unacceptable levels of a possible carcinogen in some metformin diabetes pills, marking the third time in two years that the same impurity was discovered in a widely used medicine.
In a brief statement, the agency noted that traces of a possible carcinogen known as NDMA were found in extended-release versions of metformin, but not in immediate-release versions. As a result, the FDA is contacting manufacturers to take “quick and appropriate action,” but did not say whether any recalls have so far occurred.
What is it?
STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.
What's included?
- Daily reporting and analysis
- The most comprehensive industry coverage from a powerhouse team of reporters
- Subscriber-only newsletters
- Daily newsletters to brief you on the most important industry news of the day
- STAT+ Conversations
- Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
- Exclusive industry events
- Premium access to subscriber-only networking events around the country
- The best reporters in the industry
- The most trusted and well-connected newsroom in the health care industry
- And much more
- Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
Ed, could you please share the link for the FDA communication? I can see lots of reporting on this issue, but can’t find the actual FDA communication. Thanks!
Hi Rob
Maybe I missed it, but I haven’t seen one. What I learned from the FDA came in the form an email sent me. If there is a communication, I will update the post, whenever one may be issued or I find it.
Regards
ed at pharmalot