1. Testing lab challenges FDA findings that carcinogens in metformin do not exceed acceptable levels

    Testing lab challenges FDA findings that carcinogens in metformin do not exceed acceptable levels

    As questions about suspected carcinogens in drugs continue to roil the supply chain, the FDA last month said its testing of metformin did not find any with unacceptably high levels of NDMA. But testing laboratory Valisure has challenged those findings in a new Public Citizen petition, saying it discovered problems in 42% of the batches it checked. It contends the situation is likely to get worse as the COVID-19 outbreaks wreak havoc on supply chains.

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  2. Quotes

    1. This certainly underscores the prevalence of existing pharma quality problems, which may end up becoming even worse as coronavirus continues to derail Chinese drug manufacturing, where the majority of U.S. drugs originate from.
    2. FDA has not recommended metformin recalls in the U.S..
    3. We will respond directly to the petitioners.
    4. Valisure urges FDA and industry to take swift and broad action to clean up the U.S. supply of metformin, a drug that tens of millions of Americans rely on.
    5. We must strive to avoid a repeat of over year-long rolling recalls that patients and practitioners still endure with blood pressure medications.