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Yes, some batches of metformin have been recalled. As of May 28, 2020, the FDA (FDA) had announced that it was working with five pharmaceutical firms to recall batches of metformin in which testing results revealed the presence of the carcinogen NMDA. Find out more about the recall.
NDMA, the contaminant found in metformin, is a known animal carcinogen and a probable human carcinogen. Data from numerous laboratory research studies on animal subjects and observational studies of human exposure demonstrate a strong link between NDMA and cancer. Learn more about metformin and cancer.
If you were diagnosed with cancer after metformin use, the medication could be to blame. Our metformin recall attorneys may be able to help you find out – and get justice. Find out more about pursuing a metformin lawsuit on a no-win, no-fee basis.
This recall shines a spotlight on the risks of NDMA medication contamination, a problem that has become alarmingly extensive in recent years.
For patients who haven’t developed cancer, the metformin recall is an opportunity to better preserve their health. They can talk to their doctor about safer forms of metformin (made by manufacturers whose product hasn’t been recalled), alternatives to metformin, or screenings that could help detect cancer early.
If you weren’t so fortunate, you need to know that this recall doesn’t have to be the end of the matter. Cancer patients and the surviving family of those who have lost their lives to cancer have a legal right to pursue compensation from a pharmaceutical company that produces dangerous drugs.
Medications that come with serious risks, whether through contamination or normal (but often unpublicized) adverse effects, are a particularly big problem in diabetes management. In fact, metformin cancer claims are the newest of the numerous diabetes drug lawsuits to be filed in recent years.
Having diabetes already raises your risks of a large and varied array of medical problems. The last thing you need is for the medication you must take to manage your diabetes to put you in even more danger by raising your risk of developing several types of cancer. Yet the results of testing by the FDA and external laboratories suggest that could be exactly what’s occurring.
If you took one of the recalled batches of metformin (see our metformin recall list below) and developed cancer, it’s time to take a stand against the manufacturers of these contaminated drugs.
Contact us today for your free consultation. Our metformin recall lawyers are ready to fight for you.
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Yes! The FDA announced on May 28, 2020, that the agency would be working with five pharmaceutical manufacturers to initiate voluntary recalls of metformin medications.
It’s important to know that not all formulations of metformin are included in the recall. In fact, since there are more than 20 companies currently manufacturing metformin, the current recall covers less than 25 percent of the market for this drug.
Will the metformin FDA recall be expanded? It’s too soon to know for certain. But it is worth noting that, in an investigation by an outside laboratory that evaluated contamination in 38 batches of metformin from 22 manufacturers, the percent of contaminated batches was almost double, at around 42 percent.
Although a drug doesn’t have to be pulled off the market for users harmed by it to sue, large-scale recalls are often the precursors to diabetes medication lawsuits. Before the FDA announces these recalls, patients often have no idea that they harm they suffered – in this case, the development of one of several different kinds of cancer, potentially detected at a surprisingly late stage – was related to their diabetes medication.
First of all, if you’re currently taking metformin, you should continue taking it until you speak with your doctor, the FDA advised. Given the potentially high stakes, though, you want to have that conversation sooner rather than later.
The reason why the FDA recommends patients to continue taking the drug is because stopping metformin without an alternative, an appropriate treatment plan, or your doctor’s medical expertise could cause “dangerous health risks” – risks that could cause more immediate harm.
If you previously relied on metformin to manage your blood sugar, stopping the drug abruptly could allow it to become dangerously high and result in new or worsening complications. Uncontrolled high blood sugar can, for example, lead to diabetic neuropathy, nerve damage that is often irreversible and sometimes even fatal.
Whether you take metformin now or did so previously, it’s a good idea to reach out to your doctor to talk about the best way to manage any potential increase in cancer risk.
Metformin is the generic name for the drug, which has also been sold under more than 20 brand names as well as in generic formulations made by dozens of pharmaceutical companies.
As of June 11, 2020, the 29 batches of medication that have been recalled were produced by the following metformin manufacturers:
All metformin products recalled have had metformin hydrochloride as their active ingredient.
So far, only the extended-release (ER) forms of metformin have been recalled. NDMA contamination has not been found in the FDA’s testing of immediate release (IR) forms of the medication. This is good news, since immediate release formulations are the ones most commonly prescribed, the FDA reported.
The contamination by NDMA discovered in some of the tested lots of medicine made by some manufacturers is what puts patients taking these metformin medications at risk of developing cancer. Having taken these medicines may mean you have a greater cancer risk than you would have had otherwise, and it is a good reason to talk to your doctor about the risks and benefits of metformin and about what screening tests are appropriate for you, in light of this increased risk.
What exactly has sparked recalls around the world of a medication widely considered so safe that it’s the go-to pharmaceutical treatment for type 2 diabetes? The discovery of a cancer-causing impurity called N-Nitrosodimethylamine (NDMA).
In a hurry? Here are the top three things you need to know about metformin and cancer:
What Is NDMA?
NDMA stands for N-Nitrosodimethylamine, one of the nitrosamines that can contaminate medications like metformin.
This chemical was once used to produce rocket fuel. However, that usage had to stop because it resulted in “unusually high levels of this compound… in air, water, and soil samples collected near a rocket fuel manufacturing plant,” the Agency for Toxic Substances & Disease Registry reported.
The contaminant is still produced as a byproduct of certain manufacturing processes. The only commercial production of NDMA today is as a research chemical, the Environmental Protection Agency reported. Its role in research laboratories is to induce tumors in animal subjects to facilitate the study of cancer and cancer treatments.
You don’t want a carcinogen like NDMA anywhere near you. So why does the FDA – not to mention health authorities in countries across the globe – consider any amount of NDMA to be safe?
Unfortunately, NDMA exposure occurs in a lot of other ways besides taking contaminated medicine.
You’ll find it in food products such as:
NDMA also appears in common products that include:
Your body might even produce NDMA in your stomach as it digests foods that contain alkylamines – which may be found in many different foods.
Workers in industries such as the manufacturing of rubber, tires, and pesticides may be exposed to NDMA in the workplace, the Agency for Toxic Substances & Disease Registry reported. NDMA is also found in the air, the soil, and the water. In fact, some of the human epidemiological studies that point to NDMA being a human carcinogen looked at the impact of NDMA-contaminated drinking water on cancer risk.
Since avoiding NDMA entirely isn’t feasible, the FDA instead set a “reasonably safe” allowable limit: 0.096 micrograms, or 96 nanograms.
That’s a tiny amount that’s just one-billionth of one gram – about the size of one lone cell in the human body.
When you’re talking about such a tiny amount, it may seem like a drug that contains a little too much NDMA wouldn’t be that big of a deal. But even a small amount over that limit could be risky.
“A person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer,” the FDA reported. However, “NDMA may increase the risk of cancer if people are exposed to it above the acceptable level,” according to the agency.
What makes the danger of NDMA in diabetes drugs like metformin particularly worrying is the cumulative effect of exposure. The potential increase in cancer risk is especially serious for “lifetime” medications like metformin. Over years and even decades, each dose of metformin adds to your cumulative amount of NDMA exposure and, in turn, your cancer risk. .
Decades of research have definitively shown that NDMA causes cancer in animals. The chemical is also considered a “probable human carcinogen” due to a combination of the clues gleaned from this animal research and the findings of observational studies of humans known to have been exposed to NDMA.
Researchers have studied the cancer-causing effects of NDMA on mice, rates, hamsters, rabbits, guinea pigs, cats, dogs, and monkeys. The chemical has proven dangerous across all of the mammal species studied, according to the World Health Organization.
Here is just a small sample of the findings of numerous animal research studies into NDMA and cancer:
Besides being carcinogenic, NDMA is also known to be hepatotoxic, or damaging to the liver. That’s particularly concerning for people with diabetes, because the metabolic disease itself already raises your risk of developing serious liver disease.
“NDMA has been consistently potently carcinogenic in all experimental species examined,” including non-rodent species like dogs, cats, and monkeys, the WHO reported.
Further, and even more alarming, “there appears to be no qualitative difference between rodents and humans in the formation of DNA adducts following exposure to NDMA,” the public health agency added.
What this means is that, based on the abundant evidence available, researchers see no difference in the way the carcinogen alters the DNA of a living being exposed to it, regardless of whether that being is a lab rat or a person.
NDMA has been designated a “probable human carcinogen” by:
Besides being probably carcinogenic, NDMA is known to be so toxic to humans that murderers have used the chemical to poison their victims. Ingesting as little as 2 grams of NDMA can cause a human being to die within days, according to Bloomberg Businessweek. (No batches of metformin have been found to be contaminated with NDMA at this high a level, but it’s important not to underestimate the harm that a relatively small increase in NDMA can do.)
Due to the dangers of NDMA exposure, researchers don’t do laboratory tests of the chemical in human subjects. Instead, they have learned about how NDMA increases cancer risks in humans from epidemiological case control studies.
These are observational, retrospective studies of people who were exposed to NDMA, usually in the workplace or through drinking water that has been found to be contaminated. Through these studies, researchers can identify patterns that include correlation and causation.
Here are some of the most stunning findings on NDMA and cancer risk in humans:
Besides an increased risk of cancer, NDMA has caused direct human deaths that involved cerebral hemorrhages, liver failure, distended abdomens, and enlargement of the spleen or liver, according to the WHO.
What led to metformin being linked to cancer was the discovery of NDMA in some batches of the drug.
The FDA began its investigation of the metformin-NDMA link in December, after Singapore announced its national recall on metformin medications over this issue.
In its investigation, the FDA used a technique called the LC-HRMS method, or the Liquid Chromatography-High Resolution Mass Spectrometry method, of testing metformin. Just 16 batches of metformin produced by 7 drugmakers were tested at this time.
When the FDA announced the results of its laboratory testing on February 3, 2020, it acknowledged that “low levels” of NDMA had been found in some batches of metformin. However, the agency said, “to date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA.”
Due to these findings, the FDA opted not to recommend any recalls of metformin products on the United States market at that time.
But to online analytical pharmacy Valisure, these results didn’t seem conclusive enough.
Valisure went about conducting its own investigation. First, the company obtained a much larger collection of crowdsourced samples of metformin, encompassing a total of 38 batches of the drug made by 22 different manufacturers. Then, it used the FDA protocol with those precision-boosting modifications to test each sample.
The results were eye-opening.
The results prompted Valisure to reach out to the FDA on March 2, 2020, in the form of a citizen petition to share its data and request that the agency recall the drug after all.
“The presence of this carcinogen in metformin where multiple tablets can be taken daily and often for a lifetime diabetic condition, makes this finding particularly concerning,” Valisure’s Chief Pharmacist, Deanna Akinbajo, PharmD, MPH, said.
“The data from this study adds to a growing body of evidence which strongly suggests that approximately 4 out of 10 Americans currently taking metformin are being exposed daily to unacceptable levels of NDMA, a probable human carcinogen,” said David Light, Valisure Founder and CEO. “These results indicate that contaminated batches of drugs are scattered and intermixed with clean ones throughout the American pharmaceutical supply chain.”
Valisure’s citizen petition led the FDA to revisit and expand its investigation. The new testing encompassed 37 batches of metformin medications made by 22 manufacturers.
When the agency announced its updated laboratory test results on May 28, 2020, it took a new stance. This time, the FDA detected NDMA in 12 of the 37 batches and, in batches of metformin made by 5 pharmaceutical companies, unacceptably high levels of the carcinogen.
In response to these findings, the FDA announced that it was in contact with those 5 drugmakers and would be recommending that they issue voluntary recalls of affected batches.
It’s because of this NDMA contamination that it’s possible for metformin to cause cancer. Certainly, not every patient who takes metformin – even one of the batches of metformin that are known to be affected – will develop cancer. The metformin cancer risk depends on a lot of factors that are unique to you, including how long you took metformin and how much of the medication you took.
That said, patients should take this hazard seriously.
NDMA contamination of metformin isn’t an isolated incident. In fact, since 2018, NDMA contamination of pharmaceutical products has brought about hundreds of lawsuits on behalf of cancer patients and their families.
Online pharmacy Valisure, the same pharmacy and laboratory that challenged the FDA’s findings on NDMA in metformin, was also the first to raise the alarm about NDMA in Zantac.
The surge of medication recalls pertaining to NDMA contamination over the past few years has more to do with having new ways to detect existing problems than with NDMA contamination as an emerging problem. “Today, we have better testing methods than ever before, and we know what to look for in products’ chemical structures and manufacturing processes that may increase the risk of forming low levels of nitrosamines,” the FDA reported.
It remains to be seen whether the unacceptably high levels of NDMA found in metformin are the result of manufacturing processes that aren’t up to par, poor quality control of ingredients, or another cause. But one thing is clear. The pharmaceutical industry has gotten away with allowing dangerous contamination of medications on the U.S. market for far too long.
As more patients begin to hold drugmakers accountable for the serious harm NDMA contamination causes, they’re doing more than fighting individual legal battles for the compensation they’re entitled to. Together, they’re sending a message that dangerous pharmaceutical products that put the lives of American patients in jeopardy won’t be tolerated.
NDMA is such a powerful carcinogen that the chemical isn’t linked to just one type of cancer, or even a couple types of cancer. More than a dozen different cancers are associated with this contaminant.
Some of the cancers that are most closely linked to NDMA exposure based on animal research and human observational studies include:
This isn’t an exhaustive list of cancers that could be caused or affected by NDMA, just the ones that are most strongly backed by research data. In fact, cancer lawsuits over other medications contaminated with NDMA have already been filed on behalf of patients with other kinds of cancer, including breast cancer in both men and women.
Diabetes raises your risk of many different kinds of cancer, in some cases doubling the risk you would have without this illness. Research has suggested that metformin could help reduce patients’ cancer risk – but when that protective medication is contaminated with NDMA, it may end up doing just the opposite.
If you developed any form of cancer after taking a potentially contaminated batch of metformin – particularly if you don’t have a lot of risk factors for that type of cancer – then it’s important to speak to an attorney about your situation. A metformin cancer lawyer can help determine if NDMA exposure from your medicine caused your illness.
NDMA’s dangerous effects on the liver are well-documented. The contaminant is considered hepatotoxic, the WHO reported. Not only can NDMA cause tumors to develop in the liver, but it can also damage the DNA found in liver cells, kill the cells and tissues of the liver in a condition called necrosis, and cause hemorrhage, or bleeding.
Patients with diabetes already have an increased risk of developing liver cancer. Prior to the discovery that some batches of metformin are contaminated with a carcinogen, researchers had actually found some evidence that metformin could “be associated with a lower risk of liver cancer in patients with type 2 diabetes.” Among diabetes patients who did develop liver cancer, “metformin use improved survival,” according to some studies.
And that makes it all the more disturbing that this medication that was thought to reduce liver cancer risk and improve survival – in patients already at risk, no less – has actually been exposing patients to unacceptably high levels of a carcinogen.
One particular problem with liver cancer is that early detection is difficult, according to the American Cancer Society. A physical exam is not a reliable way to find liver tumors because the rib cage gets in the way. There’s no routine screening exam that’s widely used to detect liver cancer early in patients without symptoms. In fact, early-stage liver cancer usually presents few symptoms, the Mayo Clinic reported. This is one of the reasons why the disease is tough to catch early.
The prognosis for patients diagnosed with liver cancer is bleak. The overall five-year survival rate for patients with liver cancer is just 18 percent. Those with localized liver cancer have the best chances, with a 33 percent five-year survival rate. Just 2 percent of patients whose liver cancer has spread to their distant organs will survive for five years after diagnosis.
The connection between the NDMA that’s been found contaminating metformin and pancreatic cancer is nothing new. In fact, researchers have stated that NDMA and other N-nitroso compounds are “among the most potent dietary and pancreatic carcinogens.”
Metformin has been thought to have a positive effect on the control of pancreatic cancer, much as it has with liver cancer. Researchers have established that taking metformin helps reduce the risk of pancreatic cancer in patients with diabetes.
A 2018 study out of Rutgers Cancer Institute of New Jersey in New Brunswick suggests that using metformin to target the cell signaling pathway known as REarranged during Transfection (RET) “may be an attractive and novel strategy for the prevention and treatment of pancreatic cancer progression and metastasis.” The very drug that should be protecting diabetic patients from developing pancreatic cancer may actually be fueling the risk of some patients through metformin contamination with the carcinogen NDMA.
Pancreatic cancer is rare, making up just 3 percent of cancer diagnoses in America, but it’s devastating. The overall five-year survival rate for this illness is only 9 percent. Around 37 percent of patients with localized pancreatic cancer will survive for five years, but just 3 percent of those whose cancer has spread to distant regions will, according to the American Cancer Society.
Because no test has yet been developed that can effectively reduce deaths to pancreatic cancer, routine screening for patients without symptoms is not an option for this type of cancer. That makes it difficult to detect early and harder to treat effectively. Radiation, chemotherapy, immunotherapy and targeted drug treatments are some of the options used to fight pancreatic cancer, according to the American Cancer Society.
Extensive animal studies have proven the link between NDMA and the development of kidney cancer, the Agency for Toxic Substances & Disease Registry reported. That’s likely due, at least in part, to the DNA damage and other types of genetic effects that NDMA can have on the kidneys.
The findings of a 2017 study suggested that taking metformin had a positive impact on the overall survival rate, the cancer-specific survival rate, and the risk of death among kidney cancer patients who have diabetes. High levels of NDMA contamination in metformin could offset those advantages.
The prognosis for kidney cancer patients is less grim than for patients with liver or pancreatic cancer. The overall five-year survival rate for patients with kidney cancer is 75 percent, the American Cancer Society reported. If caught early, while the cancer is still localized, the survival rate is 93 percent. Even cancer that has spread regionally has a better outlook, with 70 percent of patients living for five years after their diagnosis. Once the cancer has spread to distant regions, the five-year survival rate drops to 12 percent.
The options for addressing kidney cancer are numerous. They can range from complete removal of one kidney – because patients can live with just one healthy kidney – to active surveillance, using regular imaging tests to watch for changes in these tumors that often grow slowly, according to the American Cancer Society.
If there’s one type of cancer most closely linked to NDMA exposure, it’s probably bladder cancer. Both experimental laboratory studies on mice and observational studies of humans exposed to NDMA through contaminated drinking water have consistently demonstrated a strong link between bladder cancer and NMDA exposure.
Bladder cancer is among the most common forms of cancer, the Mayo Clinic reported. Although metformin – in general, not NDMA-contaminated batches – has shown some promise in reducing certain types of cancer among diabetic patients, bladder cancer rate does not seem to be reduced by the drug, according to research published in 2018. However, the diabetes drug may help improve patients’ recurrence-free survival rate, progression-free survival rate, and cancer-specific survival rate – provided, of course, that it’s not introducing carcinogenic impurities into the patient’s body all the while.
Most patients diagnosed with bladder cancer – 77 percent – survive for at least five more years, according to the American Cancer Society. You have the best prognosis if you were diagnosed with bladder cancer in situ, or in only the surface layer of the bladder. Patients with this early-stage form of bladder cancer have a 96 percent survival rate. If the bladder cancer isn’t detected until late, when it has spread to distant sites, the prognosis is much poorer, with only 5 percent of patients living five more years.
Treating bladder cancer thoroughly is important, particularly because this form of cancer is likely to recur even after it has been cured. To treat bladder cancer, some patients will undergo surgical procedures as aggressive as the complete removal of the bladder (radical cystectomy). An operation like this can be life-changing, and although some patients can undergo a procedure called a neobladder reconstruction so that they can urinate normally, others end up with permanent urostomy bags or reservoirs that must be drained with a catheter multiple times each day.
Radiation, chemotherapy, and other common forms of cancer treatment may also be effective in treating bladder cancer.
Despite the encouraging results of some prior studies, the findings of research on whether or not metformin protects diabetic patients against stomach cancer have historically been mixed. In a new study published in the fall of 2019, the data “suggests metformin use may not prevent gastric adenocarcinoma,” according to researchers who followed up with patients after a period of more than five years.
The evidence linking stomach cancer to NDMA, on the other hand, is very clear. Research linking the contaminant to statistically significant increases in stomach cancer risk goes back until at least 1995. Some researches have concluded that even the amount of NDMA ingested through dietary exposure can raise a patient’s risk of developing cancer by as much as 700 percent.
Stomach cancer is one of the leading causes of cancer death worldwide, but it hasn’t been among the leading causes of cancer deaths in the U.S. since the late 1930s, according to the American Cancer Society. That’s good news – because rates of stomach cancer in America are actually on the decline, not simply eclipsed by the rates of cancers that are becoming more deadly in the U.S.
Treating gastric cancer can result in big life changes. Some patients will need part or all of their stomachs surgically removed. They may need to get their nutrients through a feeding tube, at least temporarily. Some patients are able to eat, but they must change their diets substantially and eat small, frequent meals, while others remain on a feeding tube permanently.
When you think of how much more food is than pure sustenance – favorite dishes, celebratory dinners, and so much more – it’s hard to imagine a life where you just don’t eat. Anything that contributes to causing this outcome, including a contaminated drug, has lessened your enjoyment of life.
For all stages of stomach cancer, the overall survival rate is just 32 percent, but your prognosis varies a lot depending on what stage the cancer is at when detected. Patients with localized stomach cancer have a five-year survival rate of 69 percent, while those with gastric cancer that has spread to distant organs have a 5 percent survival rate.
NDMA is associated with the development of cancers of both the small intestine (also called the small bowel) and the large intestine (also called the large bowel or the colon). Colon cancer is often linked with rectal cancer under the classification of “colorectal cancer.”
Colorectal cancer is another form of cancer in which diabetes itself is a risk factor. Some research studies have suggested that metformin could protect diabetic patients by either reducing their risk of colorectal cancer or reducing the rate of deaths from this cancer, but other research findings leave that matter ambiguous.
“Overall, in the fully adjusted model, there was no association between ever use of metformin and colorectal cancer risk,” researchers reported in a study published in 2018, and “no clear pattern of decreasing risk” related to cumulative duration or recency of metformin use. However, certain aspects of the data collected in this research study suggest that taking metformin may benefit diabetic cancer patients in specific situations – such as long-term use of the antidiabetic drug and use of the medication at higher doses. Essentially, it’s still not clear despite considerable research whether metformin itself helps cancer patients.
The link between NDMA and cancers of the intestines, colon, and rectum is better documented. Researchers have known since 1999 that NDMA exposure could significantly raise your risk of colorectal cancer – at high levels of exposure, possibly even doubling the risk – as well as increasing your risk of much rarer intestinal cancer.
Intestinal cancer patients have an overall five-year survival rate of 68 percent. In localized cancer cases, 85 percent of patients survive for at least five years, but even once intestinal cancer spreads to distant regions, 41 percent of patients will survive.
Colorectal cancer has a similar five-year survival rate of 63 percent, but a much larger difference in prognosis between patients with early-stage and advanced-stage cancers. Around 90 percent of patients with localized colorectal cancer live for another five years, while just 14 percent of those whose cancer has spread to distant organs do.
Surgical treatments for colorectal and intestinal cancers can be effective in treating cancer but still reduce your quality of life. An example is if you need to undergo a total colectomy. In this procedure, your colon is completely removed, and you may have to pass stool into an external bag, temporarily or permanently.
It’s still not clear if metformin protects patients with the additional risk factor of diabetes from getting or dying from esophageal cancer. Some research findings suggest an “improved response to therapy,” while the results of other studies have been said to “demonstrate that metformin does not reduce esophageal cancer risk in type 2 diabetes mellitus patients.”
What is known is that, in observational studies of human participants who were exposed to nitrosamines like NDMA while working in rubber manufacturing facilities, “exposure to nitrosamines was significantly associated with an increased mortality from cancers of the oesophagus,” among other cancers, researchers reported back in 2000.
Esophageal cancer has a bleak outlook. For all stages of this kind of cancer, the overall five-year survival rate is only 20 percent. Even patients whose esophageal cancer is detected early, at a localized stage, have a survival rate of just 47 percent, and whose diagnosed with advanced-stage cancer that has spread to distant regions have a 5 percent survival rate.
Three types of blood cancers have been linked to NDMA exposure in long-term observational studies of rubber workers. These research findings suggest that it’s feasible that contaminated medicines like metformin could also contribute to the development of these cancers.
Multiple myeloma is such a rare form of cancer that the American Cancer Society doesn’t have five-year survival rates for this illness. However, the organization does state that “the percent of patients living five years after diagnosis has been increasing” over the past two decades.
Leukemia and lymphoma are much more common and offer more data on prognosis and survival.
Leukemia, of which there are several different kinds, is a much more common disease. The overall five-year survival rate for leukemia is 68 percent, according to the Cleveland Clinic, and some varieties of leukemia can be fully cured. However, for certain types of leukemia, like acute myelogenous leukemia (AML), the survival rate is as low as 28 percent.
For non-Hodgkin’s lymphoma, the overall survival rate is 63 percent, the American Cancer Society reported. Around 73 percent of patients with localized NHL, 72 percent of patients whose NHL has spread regionally and 55 percent of those whose NHL has spread to distant regions survive for at least five years after their diagnosis.
Even patients who beat a blood cancer like leukemia or multiple myeloma undergo a great deal of suffering during their cancer battle. They may face increased future risks and considerable medical costs for their treatments and for the additional future testing they need.
Researchers have found some evidence that metformin offers “anticancer potential” benefits to patients with prostate cancer. However, some research studies have also pointed to a link between NDMA exposure and increased risk of developing, or dying from, prostate cancer.
As the most common type of cancer in men (other than skin cancer), prostate cancer accounts for 191,930 new cancer diagnoses and 33,330 cancer deaths each year, the American Cancer Society reported. Although this cancer itself is not rare, a prostate cancer diagnosis in a patient under age 65 is. Patients with early-onset prostate cancer have been some of the plaintiffs who are suing drugmakers over NDMA contamination of other medications, such as Zantac and valsartan.
The survival rate for prostate cancer is high – with an overall five-year survival rate of 98 percent – but the disease remains the second leading cause of cancer death among males in America. Nearly 100 percent of patients survive when the cancer is caught at a localized stage or having spread only regionally, the American Cancer Society reported.
Prostate cancer often can be detected early, which allows for this high survival rate. However, just 31 percent of men with prostate cancer survive when the cancer has spread to distant regions of the body.
The average age of a patient diagnosed with testicular cancer is only 33. Because testicular cancer often strikes during the time many men are dating or intending to start or grow families of their own, the effects of needing a testicle surgically removed are more pronounced.
The survival rate for testicular cancer is high. Around 95 of all testicular cancer patients will live at least five years after their diagnosis, and even among patients whose cancer has spread to distant parts of the body, 73 percent survive for five years, the American Cancer Society reported.
However, the treatments needed to beat testicular cancer can change a man’s life. Often, you may need a testicle surgically removed, which can hinder fertility and alter your appearance. A prosthetic implant can help testicular cancer survivors look and feel more like they did before the cancer developed.
Research suggests that metformin itself may have potential to help treat, suppress the growth of, and even prevent ovarian cancer. Metformin that has been contaminated with NDMA, however, could be doing a lot more harm than good.
Research findings from primate studies conducted as early as 1996 established that the ovaries, as well as the uterus and urogenital organs, are “sensitive targets for DNA adduct damage” that results from exposure to NDMA.
When it comes to ovarian cancer, the type of cancer you have is a particularly important factor in your prognosis. While 93 percent of women who develop germ cell tumors in an ovary survive for at least five years, only 47 percent of those diagnosed with invasive epithelial ovarian cancer do, according to the American Cancer Society. The earlier your cancer is detected, the better your prognosis. Women with ovarian cancer may need to undergo the surgical removal of their ovaries, fallopian tubes, and uterus.
Although males can develop breast cancer, this happens very rarely. Fewer than 1 percent of all breast cancer cases globally, according to the Journal of Breast Health. The rareness of male breast cancer makes for an especially compelling argument that an NDMA-contaminated drug was the cause, but females with breast cancer have also brought against the makers of contaminated medications, NBC reported.
While the medication itself may have a positive impact on breast cancer, the impurity that has contaminated the recalled batches of metformin has a known negative impact. In fact, laboratory research conducted on mice grafted with normal human breast tissue even offers clues as to how NDMA contributes to the development of breast cancer.
Human breast tissue “is capable of metabolising N-nitrosodimethylamine (NDMA) to active intermediates that will react with DNA,” researchers determined. Further, the hormone estrogen – artificially implanted in the mice, but naturally occuring in human females – was “deemed to act as promoters of carcinogenesis in breast tissue.”
The link between NDMA and breast cancer has led to numerous lawsuits already. In fact, the first lawsuit filed once it was discovered NDMA was discovered in the heartburn drug Zantac was on behalf of a man who had developed a rare form of breast cancer.
Many forms of breast cancer are treatable, especially when caught early. Among women, the five-year survival rate for all types of breast cancer is 90 percent overall and 99 percent when the cancer is detected while still localized, the American Cancer Society reported. For men, the overall survival rate is 84 and the survival rate when breast cancer is still localized is 96 percent.
Metformin belongs to the drug class of biguanides. The medication is widely accepted as the front-line treatment for type-2 diabetes.
Patients sometimes take metformin in conjunction with other types of diabetes treatment drugs, such as SGLT-2 inhibitors and insulin.
Metformin is the generic name of the medication. The diabetes drug is sold under many different trade names. Some of the metformin brand names you may encounter include:
Although metformin is primarily used to treat type-2 diabetes, the medication is also used off-label to treat other metabolic or endocrine disorders, like PCOS.
Close to 80 million patients in the United States and 120 million patients worldwide take metformin, including:
Officially, metformin is only FDA-approved as a type-2 diabetes medication. However, physicians commonly prescribe the drug for off-label purposes.
Most patients take metformin for diabetes. Metformin is used to treat type-2 diabetes, a metabolic disorder that affects the way the body processes glucose, or blood sugar.
In patients with type-2 diabetes, the body doesn’t use a hormone called insulin as effectively as it should. This hormone, which is produced by the pancreas, manages blood sugar levels in the body and allows glucose to be used for energy or stored for later use.
Not having enough insulin or using that insulin effectively means that the body’s blood sugar levels become elevated. Over time, high blood sugar levels can have many negative consequences on the body.
The difference between type-1 diabetes and type-2 diabetes is that patients with type-1 diabetes don’t produce insulin, while those with type-2 diabetes produce the hormone but either aren’t able to use it effectively or don’t make enough of it. Another difference is that lifestyle factors like diet, exercise, and weight management can help patients control type-2 diabetes, while these factors don’t affect type-1 diabetes.
Metformin works to treat type-2 diabetes by reducing the body’s resistance to insulin. Metformin is not insulin. Instead, it is an “insulin sensitizer” that allows the body to respond better to insulin – either its own natural insulin or a prescribed insulin medication.
Besides prescribing metformin for type 2 diabetes, doctors may also prescribe it to help control blood sugar levels in patients with prediabetes and gestational diabetes.
One of the most common uses for metformin without diabetes is the treatment of PCOS, or polycystic ovary syndrome.
PCOS is a hormonal disorder in females that is characterized by enlarged ovaries that develop cysts, irregular or long menstrual cycles, and an excess of the male hormone androgen, according to the Mayo Clinic. PCOS can lead to many different complications, including problems with fertility, and is linked to an increased risk of developing type-2 diabetes.
What metformin does for PCOS is similar to what it does for patients with type-2 diabetes.
Women with PCOS often produce excess insulin. This overload of insulin can lead to both the production of excess androgen that may interfere with normal ovulation and the development of insulin resistance in the body, which in turn raises a woman’s blood sugar levels.
When metformin improves the body’s sensitivity to insulin, it allows for better control of blood glucose levels, which can help prevent the development of full-fledged type-2 diabetes.
The medication also helps stimulate ovulation. Women with PCOS may also take metformin to regulate periods, which can help them conceive when trying to get pregnant.
In some instances, women without PCOS may be prescribed metformin for fertility issues. Researchers have discovered that “low-dose metformin improved pregnancy rate in IVF repeaters without PCOS, probably by decreasing insulin resistance.”
The serious cancer risk increase that can be posed by NDMA contamination is outside the scope of typical metformin risks.
It’s possible to overdose on metformin. Metformin toxicity, or metformin poisoning, can be life-threatening and cause serious complications like cardiac arrest (a heart attack). However, if managed promptly, patients can recover from metformin poisoning, researchers have found.
Some side effects of metformin, like difficulty breathing, are severe and require medical attention right away. Others are not serious, though they can be annoying and uncomfortable, and they may go away once your body gets used to the medication.
One of the biggest dangers of metformin is lactic acidosis, a condition in which too much lactic acid builds up in the bloodstream. Lactic acidosis is a serious condition that can be deadly – it is 50 percent of the time, according to research.
The risk of lactic acidosis is the reason why the FDA approved metformin with a “black box warning,” the agency’s strongest warning. It’s also the reason why, until April 2016, the FDA recommended against the use of metformin in patients with any degree of abnormal kidney function.
Poorly-functioning kidneys can further increase a patient’s likelihood of developing lactic acidosis. However, the FDA relaxed its recommendations in 2016, recommending changes to the drug’s labeling for patients who have mild to moderate kidney impairments.
If you took metformin from one of the NDMA-contaminated batches, you have legal recourse.
For some patients, the harm was strictly financial. You paid for a defective drug, a medication that may well have done more damage than good to your health. If you had known that the medication was contaminated with a carcinogen, you certainly would not have spent your money on that drug – especially when so many other companies make metformin. Now that you know the truth, you deserve your money back.
For other patients, the damage done by contaminated metformin encompasses so much more. You have cancer, or have lost a loved one to cancer, and you have reason to believe the NDMA found in metformin could be to blame.
All patients who used a contaminated metformin product are eligible to take part in a class action lawsuit. An injury – like a cancer diagnosis – is not required to join a metformin class action claim.
The only thing you need to be part of a class action lawsuit is documentation that you used metformin from a batch of medication that is thought to have been contaminated. A metformin recall lawyer can help you document this fact by securing your medical and pharmacy records on your behalf, investigating your grounds for a claim and representing you at no upfront cost.
Among the earliest metformin class action lawsuits filed for NDMA-contamination were:
Even health insurance companies are now pursuing legal action against the makers of contaminated metformin. Generic metformin manufacturers Heritage Pharmaceuticals and Aurobindo Pharma are now facing a class action lawsuit on behalf of health insurance companies that said they paid $124 million in prescription drug costs for contaminated metformin. In the lawsuit filing, the insurers “accused [the drugmakers] of hiding drug contamination,” Law360 reported.
After all, these companies likely paid a good portion of their policyholder’s costs of this medication. Not only was that money ill-spent given the contaminated nature of the medications, but those insurers could now be on the hook for even more expenses if their policyholders develop cancer from taking the contaminated medications.
Is a metformin class action lawsuit right for you? Here’s what you need to know:
Class action claims are a great option for patients who didn’t suffer a physical injury from their defective medication. For patients who developed cancer and their families, an individual personal injury lawsuit is a better fit than a class action claim.
If a class action claim is for a group of consumers seeking to get back the money they spent on an unsafe product, an injury lawsuit is for individuals who suffered more extensive harm from contaminated metformin.
You might have the grounds for a metformin cancer injury lawsuit if:
As you can see, there are a lot of factors to consider in deciding whether you have the grounds to pursue a metformin cancer injury lawsuit.
You don’t need to know for sure if you have a case before you speak to an attorney. In fact, until a lawyer who is experienced in handling NDMA pharmaceutical injury claims investigates your situation, it’s very difficult to say whether you have a case.
Most patients who call a lawyer after learning that they have used a contaminated medication are still looking for answers. Maybe you’re wondering if there’s a connection between NDMA contamination of metformin and the cancer you developed. We’re happy to help you find those answers you’re looking for, at no cost. If it turns out that you don’t have a claim, you haven’t lost anything, and at least you have some peace of mind. And, if you do have a case, we’re ready to help you move forward with it on a no-win, no-fee basis.
The tragic reality is that, for some metformin users, the cancer battle can’t be won. The cancer is too advanced or too aggressive for even the best medical interventions currently available to cure.
In these instances, the patients paid the ultimate price for the negligence of giant pharmaceutical companies. And their families have suffered an irreplaceable loss.
If you believe that taking contaminated metformin may have been behind your loved one’s cancer death, you have options. You don’t have to sit by and let the drugmaker who stole your family member from you continue raking in its massive profits as though nothing happened. Your family doesn’t have to continue struggling financially as well as emotionally.
Our law firm is well-versed in the delicate matters of wrongful death lawsuits. We understand that you need answers, closure, and accountability as you attempt to cope with a loss that shouldn’t have happened in the first place. Together, we can make sure that the harm the drugmaker did to your family is recognized.
We know that no amount of money will ever replace the life that was lost. But we also know that bereaved families are going through so much. Regaining the financial stability that was threatened by your loved one’s death is crucial to moving forward with your life. Getting justice for your family member matters – not only to their memory, but also to you, as you try to make sense of the loss and of life without your loved one.
If you have questions about whether your family member’s cancer death happened because of a medication contaminated with NDMA, please give us the opportunity to help you find answers.
The money you recover in a metformin cancer lawsuit should compensate you for all of the damages – the harms and losses you sustained – that your injury caused. Some of the damages you may have in a metformin cancer injury claim include:
Some damages are economic damages, which means they have a clear price tag associated with them. You can easily calculate the total of existing medical bills, for example, or subtract from your expected income the money you lost out on while out of work. You can even use statistical methods to predict future costs and income losses.
Other damages are non-economic, which means they don’t have a clear, objective price tag. But, as any cancer patient can tell you, these losses are real. The physical pain of the cancer itself and the treatments needed to attack cancer cells, the impact of your illness on your ability to live your life – all of these damages matter.
And, if they’re caused by a negligent pharmaceutical manufacturer, they should all be covered in your metformin cancer lawsuit payout.
No metformin cancer claims have been resolved yet. However, patients can look to past lawsuits filed against the manufacturers of diabetes drugs that turned out to be dangerous for an idea of what to expect. Type 2 diabetes drugs made by many different manufacturers have been the focus of thousands upon thousands of lawsuits in recent years. These claims often result in settlements of thousands – or even millions – of dollars in compensation.
The news that some batches of metformin are contaminated with a potent carcinogen – and the resulting recalls – have left a lot of patients with questions. We’re here to answer every question you have.
The danger presented by NDMA in some batches of metformin is an increased cancer risk. At this time – partly because only some batches of metformin made by some manufacturers contain the impurity – the presence of NDMA in metformin is thought to be contamination of an otherwise safe drug.
That’s different from the heartburn medication ranitidine (Zantac), which was pulled from the market earlier in 2020. Findings suggested that all batches of ranitidine, made by all manufacturers, would contain NDMA because the medication’s inherent instability is what causes NDMA to develop.
As of early June 2020, it’s believed that only some batches of metformin contain the cancer-causing chemical NDMA. This contamination may be the result of some negligence in the manufacturing and packaging processes or of contamination of the raw ingredients used to make metformin.
In other words, metformin itself is not currently thought to cause cancer. In fact, metformin has shown promise in preventing cancers or reducing cancer mortality rates among patients with diabetes. The problem, instead, is that some of this medication has been contaminated with the carcinogen NDMA, which researchers have linked to the development of numerous kinds of cancer.
Any patient who took a contaminated batch of metformin may be eligible to pursue a class action claim.
It’s worth noting that even drugmakers whose products have not been recalled – the ones found to contain unacceptably high levels of NDMA by Valisure, but not by the FDA – are currently facing class action lawsuits.
You don’t have to prove injury or any other damages, besides the financial costs you’re seeking to recover, for a class action claim. All you need to show is that you took the medication and what you paid for it. As a result, this type of claim is easier to prove than an injury lawsuit, in which the damages may be more complex.
We can use your medical records and pharmacy records to show that you used the affected drugs and the amount of compensation you deserve.
Class action lawsuits are ideal for patients who haven’t suffered physical harm from NDMA exposure through their contaminated metformin medications, but are (justifiably) upset that the maker of their medications would put their health at risk.
Without class action lawsuits, the manufacturers of defective drugs would get away with their negligent behavior without facing the consequences. The strictly financial damages involved in cases like this probably wouldn’t be worth hiring a lawyer over for most consumers.
Despite the value they add to consumer rights and safety, class action lawsuits aren’t right for every patient who took a contaminated batch of metformin. These lawsuits don’t take into account any real injuries you suffered, like developing cancer, or the consequences of those injuries. If you developed cancer, you are entitled to a lot more than just getting back the money you spent on the bad drug. You wouldn’t get that from a class action lawsuit.
To find out for sure if you have the grounds for a lawsuit over NDMA-contaminated metformin, you need to speak to an attorney. There’s no other reliable way to understand your legal rights and begin moving forward with your claim.
Our metformin lawyers are currently helping patients move forward with both class action claims and cancer injury lawsuit claims. We’re also here to help the families of metformin patients who have passed away due to cancer.
Qualifying for a metformin class action lawsuit is easier, as a matter of finding out if you have documented use of a contaminated batch of metformin. We can help determine if there is a class action claim already pending that you would be eligible to join, or if your situation would be the grounds for the start of a new class action lawsuit.
Determining whether you have a metformin cancer injury lawsuit is a more complex matter. We will speak with you in greater detail about the length of use of metformin, the timing of the cancer diagnosis, the type of cancer, and other factors that can help us understand whether there’s a link between NDMA exposure from metformin and your cancer. We will also talk with you about your damages.
Regardless of which kind of claim you may be eligible to pursue, you should be able to get all of your questions answered by an experienced legal professional at no cost and with no risk. That’s why the consultation is always free at Console and Associates.
Give us a call today – because nothing should stand in the way of you finding out your legal rights and options.
Since you first found out about the NDMA impurity in metformin, you’ve been wondering how this contamination may have impacted you and what rights you have. Now, it’s time to move forward with getting your questions answered and getting the compensation you deserve.
Our experienced pharmaceutical injury attorneys are reviewing metformin claims absolutely free.
With remote intake options and plenty of ways to get in touch with us, we take the stress out of hiring an attorney. Let us handle your legal matter, so all you need to focus on is your health.
June 11, 2020 – Miami Herald – Two weeks after the FDA’s alert, Lupin Pharmaceuticals became the fifth pharmaceutical company to recall a batch of metformin that, in the FDA’s investigations, was contaminated with unacceptably high levels of the carcinogen NDMA.
May 29, 2020 – Associated Press – In its alert about unacceptably high levels of NDMA found in some batches of metformin, the FDA specified that patients should not stop taking metformin without first speaking to their doctors.
May 27, 2020 – Reuters – The FDA issued a statement that the agency has identified high levels of NDMA in batches of the metformin products of five drugmakers and was recommending recalls of the affected batches.