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Metformin Recall Urged Due To Presence of Cancer-Causing NDMA

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An independent online pharmacy is calling for federal regulators to issue a metformin recall, indicating that the generic diabetes drug contains the same cancer-causing agent that has led to massive recalls for Zantac, valsartan and other medications in recent months.

In a citizen’s petition (PDF) filed with the FDA on March 2, Valisure reports that it has detected high levels of N-Nitrosodimethylamine (NDMA) in specific batches of metformin tested by the online pharmacy.

Given the cancer risk linked to NDMA, the petition calls for a recall to be issued for those batches of metformin, and for a widespread investigation of other versions of the widely used front-line treatment for type 2 diabetes.

The petition comes less than a month after the FDA declared that it had not found unacceptable levels of NDMA in metformin after conducting its own investigation.

NDMA is a chemical byproduct, which is considered a carcinogen. It used to result from making rocket fuel in the early 1900s, but today is only used in laboratory experiments to induce cancer in animal test subjects.

In recent months, detection of the chemical in other drugs has resulted in wide scale Zantac recalls and valsartan recalls, after it was confirmed that dangerously high levels of NDMA were present in the popular heartburn and blood pressure medications.

Late last year, reports indicated that NDMA was also discovered in some metformin samples sold outside the United States, raising concerns that metformin recalls may be necessary.

Metformin is sold under several brand names, including Glucophage, Carbophage, Fortamet, Diabex and Riomet. It is also often used in combination with other diabetes drugs, and is widely used worldwide.

Valisure indicates that it closely followed the FDA’s recommended testing procedures at a lab specifically accredited for analyzing levels of NDMA.

“Valisure’s analysis of 22 companies selling metformin and a total of 38 batches revealed 16 batches from 11 companies where NDMA levels were detected above the 96 ng daily acceptable intake limit, which was factored using a common number of tablets taken per day,” the petition states. “Several batches contained over 10 times the daily acceptable intake limit and there was significant variability from batch to batch, even within a single company; underscoring the importance of batch-level chemical analysis and the necessity of overall increased quality surveillance of medications.”

The company noted that the FDA’s own analysis did not find these levels of NDMA and suggested the agency needs to take a broader approach to its testing.

NDMA In Zantac and Valsartan

Valisure is the same pharmacy which first raised alarms about the link between Zantac and cancer in September 2019, after finding that some pills contained 3,000,000 ng of NDMA. This led to further FDA testing, which confirmed the high levels were present in virtually all Zantac products and their generic equivalents, resulting in a widespread, and still ongoing, Zantac recall.

Concerns over NDMA drug contamination began to emerge in 2018, with an investigation into a number of generic blood pressure drugs that were found to contain high levels of the chemical. This led to several rounds of recalls for valsartan, losartan and irbesartan, and investigations suggested that NDMC may have contaminated the drugs as a by-product of changes in the generic drug manufacturing process.

In response to concerns about the cancer risk with valsartan and other similar drugs, and the possibility of shortages for the hypertension drugs, the FDA established a permissible daily limit for NDMA at 96 nanograms, requiring pills that may expose users to more of the carcinogen to be recalled.

Unlike valsartan, where NDMA contaminated the pill due to the manufacturing process, it appears that NDMA in Zantac was caused by the instability of the active pharmaceutical ingredient, which may produce NDMA when exposed to high temperatures, such as during transit or inside the human body. However it is not yet clear what processes are causing the levels of NDMA detected in metformin.

While drug makers and federal regulators indicate they are continuing to investigate the underlying cause of both the NDMA contamination, many consumers diagnosed with cancer in recent years are now pursuing valsartan lawsuits and Zantac lawsuits, alleging they may have avoided a cancer diagnosis if other treatments had been used.

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153 comments

  1. Rose Reply

    I was on metformin 10yrs or longer. I was put on Januvia last year for a short time. No I am on Janumet since last year.

  2. Raymond Reply

    I have been on Metformin for about 15 years and was just diagnosed with cancer about a month ago.

  3. Marjorie Reply

    I developed an autoimmune disease which caused rashes and later development of Rheumatoid Arthritis. Suffered for months and months while they tried all kinds of medications (all of which I had bad side effects) so now I just live with the arthritis and am on insulin.

  4. Bertha Reply

    I’m been on Metformin for years. I’ve had Stomach Cancer so I need to know is this true.

  5. Friend Reply

    They don’t list the batch numbers that are found in each bottle so that consumers would know if they are affected.
    It’s from a law firm looking for business.
    I would call my pharmacist about this first

  6. Samuel t. Reply

    I’ve been taking metformin for 3 years

  7. Glenda Reply

    I scared to take meds now why cant they find out all this before they try to kill all of us I have been taking this for about 20 years off and on. Now what..

  8. Florence Reply

    I hope it’s not true I took metformin for years at least 15 years or longer.

  9. Alfredia Reply

    I have been on Metformin for years and in 2016 I was diagnosed with Breast Cancer is there any connection.

  10. Stephen Reply

    This medication makes me sick to my stomach when I take it…I’ve informed my Physician and my Pharmacist and neither has offered a solution

  11. Melody Reply

    I am on metformin, & have been for years. I have been taking Nexium daily for 30 years! This news is alarming!

  12. Tammy Reply

    I was diagnosed with breast cancer back at the end of 2018. It resulted in a double madectomy and numerous cancer treatments. My surgeon said when i was diagnosed i already had the cancer 5 years. I am a diabetic i have taken metformin longer than 5 years. I did not have a genetic proclivity to getting it i was genetically tested. Do i have a lawsuite case possibly.

  13. Laurie Reply

    My husband was diagnosed with stage 2 kidney cancer. He has been on Metformin for maybe 2 years now. He had part of his kidney removed.

  14. Tim Reply

    I’ve taken these for years. So what do we do with the meds.

  15. Jamaine Reply

    Is this true I’ve been taking this medication for years do I need to change to another medication

  16. Jennifer Reply

    How will I know if my meds were part of the recalled ones?

  17. Lisa Reply

    I have been on this drug for years. Metformin. Is this tru?

  18. Jill Reply

    4 of us take Metformin 2x a day for many years!

  19. John Reply

    Is this real? I’m taking 1000 mg twice a day.

  20. Mary Reply

    I take Metformin HCL 500mg twice daily.
    The mfr is Aurobindo.

  21. Tory Reply

    I was just put on this for PCOS. Is this true?

  22. James Reply

    So is my diabetic meds okay I’ve been on this one for at least 2 yes now ?

  23. Terty Reply

    Took it for years had terrible stomach issues been off it for several years still causing me problems had 4bypasses while on this drug toe amputated gall bladder surgery amoung other purseagers

  24. Donna Reply

    I have taken Metformin for at least 6 years maybe longer. 2000 mg per day.

  25. Crisanda Reply

    I’ve been on Metformin for awhile now for my diabetes. I take 1000mg twice a day. I have a history of cancer in my family already so I hope this isn’t the truth about Metformin!

  26. Euginna Reply

    Is this why I my stomach is always upset or I am vomiting all the time the last five years while taking this.

  27. Linda Reply

    I have been taking this drug for years for my diabetes and also have had breast cancer. IUs this true? Should I stop taking and call my physician?

  28. Allen Reply

    Wife and I have been on metformin for years what are our options

  29. Vincent Reply

    Wish the report had stated the batch and companies whose metformin tested positive for the cancer-causing NDMA so we can buy the good metformin.

  30. Carolyn Reply

    I was on metformin for years. I was diagnosed with cml..
    Chronicmyeloid leukemia and also non hodgkins lymphoma. I also had chemo.

  31. Kristen Reply

    My husband has been on this for years and actually had a high carcinogen level in his blood on recent tests…………

  32. PA Reply

    My 33 yo daughter has been on this for PCOS for at least 4 years and was diagnosed and treated for breast cancer in August!

  33. Mark Reply

    My husband was On it for 10 years are his kidneys he’s in stage 4 kidney failure becareful

  34. Cindy Reply

    I takr metformin 500 mg twice a day should i stop

  35. Kathy Reply

    You don’t want us to drink diet drinks because of the artificial sweeteners in them causing cancer but you can give us cancer causing medication.

  36. Rodney Reply

    I have been taking Metphormin for about 8-10 years.

  37. Cynthia Reply

    My husband has taken this for years, already had both hips replaced and now on insulin. Should we worry?

  38. Eric Reply

    I’ve been taking Metformin for 20 years and now I have stage 4 bone marrow cancer.

  39. Gina Reply

    I have been on Met Forman for over 15 years begin at 500 but the last few years it’s been 1000 twice daily

  40. Evelyn Reply

    I have been using the meds losartan and metformin for a long time now. So is what I read true?

  41. Myra Reply

    I have been taking Metformin for several years now. If this is true why haven’t Doctors been notified to stop prescribing this for their patients? And why has it not been pulled from pharmacies.

  42. Brandy Reply

    What batches are being recalled?

  43. Cory Reply

    Wow! Another one of my medications! I had been taking valsartan previously for my blood pressure for awhile before it got pulled. Now, my metformin is another one!? I have been on metformin for about 6 to 7 years now for my type 2 diabetes. Been taking 1000 to 1500 milligrams a day ever since. This is getting alitte ridiculous with the cancer causing agents in medications, don’t you think?!

  44. Ova Reply

    I took metformin for a week and I got so sick .took it for stage 2 diabetic . Was throwing up diarrhea couldn’t hold food or water down always sweating . My chest hurt for days felt like I had cracked my ribs from throwing up so much. And then I felt like I was having a heart attack so I called my doctor and he took me off it and put me on another medication.

  45. Sadie Reply

    I have been on metformin for about 12 years…I noticed my hair is falling out bad…could this be the cause….I take metformin 1000 mg twice a day

  46. Debbie Reply

    There is a link, in the above story, that will take you to the PDF and give you all the information on Lot #’s, manufactures, etc. I think, if I read it correctly, my Metformin is good to go but I will follow up.

  47. Denise Reply

    I have been on metformin extended release for a very long time. I had the stomach issues with regular metformin. I just started chemo for a form of ovarian cancer. If my genetic testing results come back with nothing to show why I got cancer, I would have to assume this had something to do with it.

  48. Theresa Reply

    I have been taking metformin for about 7 years and have just been diagnosed with breast cancer. I will be asking the doctor about this.

  49. Anita Reply

    I to have been on metformin For15,+years.2017. I had half my lung removed.Lung cancer.I have never smoked ever.my cancer was a slow growing kind.I had it for 5 years or more.I have nothing but trouble now .DR.said no could it be?

  50. Damaris Reply

    Reading through this article and the comments, it just reminds me why so many of my friends, family, pts, and colleagues have gone off of Metformin and have opted for another product out there that was used in ayuvedic medicine to get off of this and insulin, including me with metformin and actually reverse T2. Just read the side effects as it also causes joint pain in some folks as well. I work with various pts who are struggling to get off synthetic insulin and metformin, and are using a different product with some tremendous results. Be encouraged, there is hope out there!!

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