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.
NDMA is an organic chemical that was once used to make rocket fuel and is an unintended byproduct of certain chemical reactions. The World Health Organization and the U.S. Environmental Protection Agency consider the impurity to be a possible carcinogen, and its appearance in a growing list of medications has prompted regulators and manufacturers to scramble to understand the reasons.
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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