Some Generic Metformin Contains Nearly Double Daily Limit Of NDMA, Class Action Lawsuit Claims
A clas action lawsuit has been filed against a manufacturer of generic metformin, alleging that versions of the popular diabetes drug were distributed with nearly twice as much of a cancer-causing chemical than is allowed by federal safety regulations.
The complaint (PDF) was filed by Kristen Wineinger in the U.S. District Court for the District of New Jersey on March 9, pursuing damages on behalf of all users of generic metformin sold by Granules USA, Inc. and Granules Pharmaceuticals, Inc.
According to the lawsuit, recent tests revealed that Granules’ generic version of metformin contained levels of N-notrosodimethylamine (NDMA) that were 1.7 times higher than the FDA’s daily limit of 96 nanograms (ng).
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Learn MoreNDMA 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 first warned about the potential risk that problems may also be impacting metformin, after some versions of the drug sold outside the United States tested positive for NDMA, raising concerns that metformin recalls may be necessary. However, the FDA indicated that testing of products distributed in the U.S. found that the metformin NDMA contamination levels were undetectable or below federal limits for exposure to the chemical.
Earlier this month, the independent online pharmacy Valisure filed a citizen’s petition urging the FDA to issue metformin recalls, after independent testing found levels of NDMA in certain pills that was higher than the agency’s recommended daily exposure threshold of 96 nanograms.
Metformin is sold by a number of different generic drug makers, and also marketed under several brand names, including Glucophage, Carbophage, Fortamet, Diabex and Riomet. It is also often used in combination with other diabetes drugs.
Wineinger, of Indiana, indicates she used Granules’ version of metformin for some time before learning it was one of the products tested by Valisure, which found high levels of NDMA.
According to Valisure, each 500mg Metformin ER tablet sold by Granules contained about 41 ng of NDMA. Since the standard dose is four tablets daily, that adds up to about 164 ng per day of NDMA exposure, which is 1.7 times the amount recommended by the FDA.
“When purchasing metformin from Defendants, Ms. Wineinger reviewed the accompanying labels and disclosures, and understood them as representations and warranties by the manufacturer, distributor, and pharmacy that the medications were properly manufactured, free from defects, and safe for their intended use,” the lawsuit states. “Ms. Wineinger relied on these representations and warranties in deciding to purchase metformin from Defendants, and these representations and warranties were part of the basis of the bargain, in that she would not have purchased metformin from Defendants if she had known that they were not, in fact, properly manufactured and free from defects.”
A similar metformin class action lawsuit was filed just days earlier, on March 3, against a number of other manufacturers. To date, none of the drug makers have agreed to issue a recall of metformin, raising concerns among user and the medical community. However, health officials stress the importance that patients continue to take their prescribed diabetes treatment, unless otherwise directed by their doctor.
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 in pharmaceutical drugs 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.
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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44 Comments
E. LindaSeptember 4, 2022 at 6:10 pm
They have been trying to get me to take this drug since 2005, saying I was borderline diabetic. It was 119, and still, to this day, my new Dr told me the same. I refuse to take them, had her stop prescribing them, especially now after all the bad reports and recalls. I was told by 3 people who have type 2 diabetes, that they would never take Metformin if their reading was that low. So I’m glad I [Show More]They have been trying to get me to take this drug since 2005, saying I was borderline diabetic. It was 119, and still, to this day, my new Dr told me the same. I refuse to take them, had her stop prescribing them, especially now after all the bad reports and recalls. I was told by 3 people who have type 2 diabetes, that they would never take Metformin if their reading was that low. So I’m glad I went with my gut.
WandaJuly 17, 2021 at 2:02 am
Took metformin and now I am four stage of kidney failure I can go anywhere with warring a pad thank you Wanda Huff
DebbieFebruary 21, 2021 at 7:56 am
My wife was diagnosed with pancreatic cancer on02/18/2021 she has taken metformin for over 4 years she has 8 months to a year to live.hers was by granules pharmaceutical distributed by Wal-Mart pharmacy
ivanDecember 3, 2020 at 11:42 pm
I have been taking metformin for years and have been diagnosed with cancer spots on my kidney and liver.
MarthaDecember 3, 2020 at 6:40 pm
I started taking Metforman about 4 weeks ago and am already am experiencing nausea, vomiting, diarrhea, stomach pain. Actually in urgent care right now having tests done. I don’t think I want to continue on this medication.
HoracioNovember 10, 2020 at 11:49 pm
I’m been taking metformin for about ten years and my stomach is a mess among some other problems
GenevaNovember 8, 2020 at 11:35 pm
Took metformin and kidney went into renal failure. I developed flesh eating diease. Almost lost my life.
DonnaOctober 23, 2020 at 4:55 am
I have been taking the twin labs met Forman that’s been required for cancer producing chemicals I have had our ups precancerous and now a cancerous polyps can this be due to his drug
CathyOctober 20, 2020 at 7:00 am
I started taking Metformin in 2007 and ended in 2018 Dr. Just took me off. Same their had been a recall. I has cancer in 2010 and 2013 Breast Cancer Mastectomy in 2014. I’m looking to join case action lawsuits !
JphnAugust 7, 2020 at 4:39 pm
I was prescribed Metformin and took it about 7 months before stopping because of stomach problems then tested positive for colon cancer and still have stomach issues today
TIFFANYAugust 6, 2020 at 2:55 am
I took metformin ER for years and was diagnosed in 2019 with stage 3b colon cancer at age 36.
SusanJuly 30, 2020 at 2:37 pm
I started talking Metformin about 6 years ago because I was borderline or pre-diabetic. Since then, I have been diagnosed with 3 unrelated cancers. 1 type is so rare that only 1 in 1 million get out! This has been wondering and very concerned!
FredJuly 20, 2020 at 8:35 pm
Hi i beed taking metformin for a couple years. I recieved a letter saying i may have the recalled meds so i checked the bottle and yes thats what ive been getting. I have been having troyble breathing and stomach issues since i been taking it. Never guessed thats what it could have been
LarryJuly 18, 2020 at 5:06 pm
Just got taken off of metformin after 15 years and have been having kidney function stage 4 renal disease problems readings of only 17 on my test. The dr. Is saying the metformin is mostly to blame. Anyone else with this problem.
MonicaJuly 13, 2020 at 7:27 pm
I’ve been on Metformin for years and recently started using the G7 brand from Granules. Fortunately, until now, I haven’t experienced issues. However, since starting G7, my stomach aches, I’m vomiting, & have diarrhea. Even if this lot isn’t on the recall list (I checked), something isn’t right. Praying for us all because we need medication that works & not cause patients/users harm.
MickeyJuly 11, 2020 at 12:31 am
My husband and my 2 daughters are taking Metformin for many years. I am very upset and angry about NDMA being higher than the FDA limit. Looks like there is no company's products that has not been recalled. I am not sure what to do. Their by products are outsourced from China and manufactured in India. Even TEVA an Israeli company made in india is being recalled.
AudreyJuly 8, 2020 at 4:55 pm
our 45 yr old daughter Dx with stage 4 bladder cancer 9/2011 and passed away 8/2012. She was in Metformin 1000 mq bid and Avandia 8 mg qd.
CrissyJune 27, 2020 at 3:18 pm
Me and my mom have been taking for some time and started having stomach issues lately.
wilhelminaJune 24, 2020 at 2:56 am
I have been taking 500 mg of Metformin for about 40 years. some time ago, about 15 years, my feet became tingling and numb. It has gotten increasingly worst so that some days I cannot walk. I am diabetic 2 with sugar levels always far under normal. The condition jhas been diagnosed as diabetic neuropathy. I have many tests of the nerves, muscles , blood tests (many for everything) they found every[Show More]I have been taking 500 mg of Metformin for about 40 years. some time ago, about 15 years, my feet became tingling and numb. It has gotten increasingly worst so that some days I cannot walk. I am diabetic 2 with sugar levels always far under normal. The condition jhas been diagnosed as diabetic neuropathy. I have many tests of the nerves, muscles , blood tests (many for everything) they found everything normal. I am scheduled for an appointment with an orthopedic surgeon next month. No one can explain why I am having these conditions with my feet when all sugar tests are below normal.
ShelbyJune 23, 2020 at 3:16 pm
I have been taking metformin for a year and I've suffered from stomach pain. I don't believe I was meant to be prescribed this drug. I have PCOS and I was told that this drug would help regulate my hormones. I had been taking 750 mg for a year. Now I wonder if it has caused infertility.
KariJune 19, 2020 at 4:32 am
I've been on 2000mg of Metformin ER daily for 2 years almost for PCOS to help p with insulin resistance. I'm worried.
ElizabethJune 18, 2020 at 5:22 pm
The pharmaceutical companies make far to much money to be producing a medication that will cause more of a problem than what it is suppose to help. Walmart Pharmacy just called me to give me the warning that I was given a Metformin ER that had to much of a cancer causing additive. What am I I suppose to do with that information?
AliceJune 12, 2020 at 7:35 pm
I have been on metformin for years. I just came back from my pharmacy and the last 2 90 day supply bottles I have were from granules pharmacy. I’m a little concerned.
GraceJune 11, 2020 at 4:53 am
Im also on metformin long term n very concerned
EngelsJune 11, 2020 at 3:49 am
I am very concerned taking 1000.mg twice a day not feeling well with all this medication loosing my trust in the healthcare system.
StanleyJune 10, 2020 at 2:47 am
Been taking it for years and it makes me sick to my stomach every time. Very concerned been taking that for awhile now
DeborahJune 9, 2020 at 2:12 pm
I've been taking metformin 500 mg twice a day for close to ten years. In July of 2019 I was diagnosed with metaplastic breast cancer. I had to have surgery, chemotherapy, and radiation. Now I'm subject to five years of hormone blockers. I have no history of breast cancer in the family. I can't help but wonder about the metformin connection
RafaelJune 9, 2020 at 4:38 am
I have been taking metformin 500mg. 2 times a day. I have numbness on both feet.
DiamondJune 8, 2020 at 10:14 pm
My mom died 6 years ago she has type two diabetes and was taking Metformin and in 2013 she was diagnosed with cholangia carcinoma and died. I was wondering if me and my father are eligible for compensation, because no one in my family has a history of cancer.
DeborahJune 8, 2020 at 5:24 am
I have been taking metforfmin for many years and have concerns.
BeverlyJune 6, 2020 at 7:33 am
Was taking metformin er 500mg 2x day. Dr found renal cell carcinoma in right kidney purely by accident, had to have right kidney removed. Is there anything I can do about this?
JessicaJune 6, 2020 at 3:18 am
I have been taking Metformin XR 750mg by Amneal Pharmaceuticals since 2012. This is one of the brands now recalled. I was diagnosed with pre-myeloma in 2016, and still require monitoring by an oncologist, since this condition puts me at high risk for blood cancers. Could there be a connection?
PamelaJune 5, 2020 at 6:02 pm
I've been taking both Valsartan and Metformin for years. Last year I was diagnosed with breast cancer.
AnnelieseJune 4, 2020 at 7:21 pm
I have been taking Metformin for about 10 years and last year I was diagnosed with pancreatic cancer. There is no history of cancer in my family.
TenaJune 4, 2020 at 2:22 am
I take Janumet XR 50/1000 I have tingling in my feet and toes is this drug safe to take
CristinaJune 2, 2020 at 7:05 pm
I took metformin for about a year and a half and it constantly had my stomach upset am I at risk of getting cancer
StephenMay 31, 2020 at 2:16 pm
Taking 1000mg of Metformin 2x daily says on label NDC 60429-113-18 Am I ask risk for cancer?
SandraMay 31, 2020 at 12:27 am
I was diagnosed with stage 3a lung cancer. I have been on metformin for over 2 years. I am going through chemotherapy and radiation I was diagnosed in February 2020
JANMay 30, 2020 at 8:30 pm
My husband has been taking Metformin for about two years for Type II Diabetes. Last month he was diagnosed with pancreatic cancer. I am very interested in learning about any correlation between Metformin usage and cancer. I happen to know of others (3 personal friends) who have taken Metformin over a period of time and were later diagnosed with pancreatic cancer.
MicheleMay 30, 2020 at 4:37 pm
I’ve been taking Metformin HCL ER 500mg tablets 4 tablets daily, I have been having stomach issues!
PatriciaMay 5, 2020 at 10:55 am
My husband was a diabetic taking Metformin for a few years. In late 2017 he started having pain in his right knee. Thinking it was arthritis he waited until after the holidays to see the doctor. He was diagnosed with stage 4 cancer on January 16th, 2018. Other than the pain in his knee he had no other symptoms what so ever to lead him to believe anything was wrong. Sadly, by the time we were aware[Show More]My husband was a diabetic taking Metformin for a few years. In late 2017 he started having pain in his right knee. Thinking it was arthritis he waited until after the holidays to see the doctor. He was diagnosed with stage 4 cancer on January 16th, 2018. Other than the pain in his knee he had no other symptoms what so ever to lead him to believe anything was wrong. Sadly, by the time we were aware he had cancer it had spread throughout his body. My childhood sweetheart, bestfriend and soulmate of more than 40 years past away on May 18, 2018. If I find out that the NDMA in his Metformin was responsible for my husband's death - somebody will pay for this good man's death.
DavidApril 30, 2020 at 12:06 pm
I've been on Janumet and Metformin for many years now and since the time I have been prescribed them,my toes have become numbed and during these more recent years, both of my feet have become completely numbed. I was told that it is the Metformin that caused it to happen and I also heard that some people had the same numbness which started in the toes then continued to the feet and later those peo[Show More]I've been on Janumet and Metformin for many years now and since the time I have been prescribed them,my toes have become numbed and during these more recent years, both of my feet have become completely numbed. I was told that it is the Metformin that caused it to happen and I also heard that some people had the same numbness which started in the toes then continued to the feet and later those people ended up losing their feet by having them cut off. I certainly hope that isn't the next thing that's going to pĺhappen to me. I've been disabled since 1998 with many other health problems and now I am very concerned over the medicines i take. Thank you for hearing me out and please let me know if any thing can be done over the numbing of my feet.
GloriaApril 22, 2020 at 1:46 am
I’m been taking Metformin for ten years or more and also a few other medicines you have listed. I have had problems with my digestive system. It’s really make me think all the medicine we’re taking is bringing down our HEALTH.
fredApril 21, 2020 at 6:15 pm
I started usng Metformin in 1990. I lost part of my left forefinger to cancer and they had to take out my Spleen which had cancer on it. Now I have to take chemo.