In 2020, the U.S. Food and Drug Administration posted laboratory results showing N- Nitrosodimethylamine (NDMA) levels in some metformin products approved in the U.S.
FDA has determined that the levels of NDMA in metformin products tested in low levels, although experts are uncertain if long-term exposure to such toxins can lead to cancer.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.The health effects of overexposure to NDMA include jaundice, nausea, fever, vomiting, abdominal cramps and dizziness. High levels of exposure can cause reduced function of the kidneys and lungs, and has been linked to cancer.
Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. Patients should continue taking metformin to keep their diabetes under control. It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.
FDA plans to post the methods used in laboratory testing of metformin in the near future. FDA is also collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.
FDA will continue to monitor NDMA in metformin, along with other drugs products, and will provide updates on developments, including product recalls.
Zantac NDMA contamination has also been a source of concern and has led to drug cancer lawsuits.
Joe Lyon is a highly-rated pharmaceutical injury attorney investigating NDMA contamination cancer risks and Metformin injury and complications for injured plaintiffs.
The Lyon Firm works with industry experts to build the strongest case and engage large drug companies following drug recalls.
ABOUT THE LYON FIRM
Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.
The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.
NO COST UNLESS WE WIN
The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.
Following reports of contamination of N-nitrosodimethylamine (NDMA) in metformin in other countries, the FDA is addressing the levels of NDMA in the nation’s metformin supply. This FDA action follows a recent statement regarding similar NDMA contamination in ranitidine and a recall of generic angiotensin II receptor blockers.
A Metformin recall has not been initiated at this point. As of now, the FDA suggests patients continue taking metformin to keep their diabetes symptoms under control. Metformin is the first-line drug used for high blood sugar levels in type 2 diabetes patients.
Levels of NDMA have been found in metformin supplies in other countries, according to the FDA. The acceptable daily intake limit for NDMA is the U.S. is set at 96 nanograms. Toxic substances like NDMA may increase the risk of cancer if people are exposed to unacceptable levels or have long-term exposure.
Sun Pharmaceutical voluntarily recalled one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake limit established by the FDA.
RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Patients taking RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL are advised to continue taking their medication and contact their pharmacist or physician to discuss an alternative treatment.
Marksans Pharma expanded an earlier recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg. Marksans observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day.
The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side and Metformin Hydrochloride Extended-Release Tablets, USP 750mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘102’ on one side and plain on the other side.
Most drugs containing Metformin are still on the market, and have not been recalled. However, in Canada and other nations, the health authorities have taken the step of recalling contaminated Metformin products.
In 2018 the American Diabetes Association (ADA) reported over 34 million Americans, or around 10 percent of the population, had diabetes. The CDC has stated that up to 100 million Americans are living with pre-diabetes. Another 1.5 million diabetes patients are diagnosed each year.
Patients are typically moved onto various diabetes drugs and medications, including inculin, Metformin, Sulfonylureas, Meglitinides, Thiazolidinediones, DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT-2 inhibitors. Metformin is used in medication under the brand names Glumetza, Riomet, Fortamet, Glucophage, and Janumet.
According to the Mayo Clinic, metformin is usually one of the first medications prescribed for type 2 diabetes, and is the most extensively used oral therapeutic agent for type 2 diabetes mellitus (T2DM).
The American Diabetes Association and other medical experts recommend it as the first line treatment for T2DM. However, the drug is not without risks. Patients have reported serious health issues and Metformin injury, including kidney disease, and liver damage.
A report published by Diabetes Care analyzed data from several studies and found individuals taking a metformin drug performing significantly worse on cognitive performance tests. Patients with type 2 diabetes performed poorly on cognitive impairment tests, with patient taking metformin performing even worse.
The researchers also found metformin was associated with a vitamin B12 deficiency, potentially linked to the impaired cognitive performance. Metformin has been called a wonder drug in treating type 2 diabetes, and has saved lives, though is not without health risks. The FDA is now investigating whether Metformin is contaminated with cancer-causing contaminants.
Metformin continues to be heavily prescribed, in conjunction with other diabetes medications. Currently, over 150 million people worldwide are using metformin in some form. The most common side effects include gastrointestinal distress, nausea, diarrhea and upper abdominal discomfort. A larger concern is the potential for lactic acidosis, which can be serious.
Metformin may cause lactic acidosis when lactic acid production is high and lactic acid disposal is reduced, such as in cases of circulatory failure, sepsis, and anoxia or hypoxia.
Recent medical studies involving diabetic patients using SGLT-2 inhibitors show patients at an increased risk of lower limb amputation, Fournier’s Gangrene, bone fractures, kidney and liver failure and heart attacks.
The New England Journal of Medicine published a recent report that concludes SGLT2 inhibitors (sodium-glucose cotransporter-2 inhibitors) are associated with approximately twice the risk of diabetic ketoacidosis as DPP4 inhibitors, another option for diabetes patients.
Since two clinical studies demonstrated a link between one SGLT-2 drug, Invokana, and an elevated risk of lower limb amputations, the U.S. Food and Drug Administration (FDA) has advised prescribing doctors to discontinue the medication for patients who experience unusual pain, sores or lower extremity infection.
This class of diabetes drugs is relatively new, but already hundreds of injury claims have been filed against pharmaceutical companies by individual patients. Patients are reporting kidney damage, Fournier’s Gangrene, amputations, ketoacidosis and heart attack events.
Attorneys claim the drug manufacturers involved have failed to properly warn consumers and doctors of the SGLT-2 drug injury risks and failed to properly test the medication before selling it to the public.
Diabetes is a disease described when blood sugar (glucose) levels are too high in an individual. Glucose is generally replenished with foods and beverages a person consumes. Most people consume sugars and their body responds by releasing insulin, a hormone that breaks sugars down into glucose. The glucose becomes a person’s basic energy source.
But patients with diabetes have trouble with this process. With type 1 diabetes, the body will not produce enough insulin, and in type 2 diabetes, the body may not use insulin properly. In both types, there is too much glucose in the blood, and leads to complications and the need for medications. Without diabetes drugs, patients risk heart attacks, strokes, kidney disease and other health risks.
Diabetes medications are designed to assist the body balance glucose levels, though some drugs, including Invokana, Onglyza and others may lead to more severe drug injury. There are a variety of diabetes medications that may keep blood sugar levels under control. Incretin mimetics, for example, are a drug that “mimics” incretin hormones, prompting the pancreas to release more insulin.
Another popular diabetes drug is Invokamet, which is a SGLT2 inhibitor combined with metformin. But Invokana and Invokamet may increase the risk of ketoacidosis, acute kidney injury, urinary tract infections, bone fractures, and leg and foot amputations.
Recent research of one SGLT-2 inhibitor called Invokana concluded that the risk of amputation doubled during drug use in some patients. Individuals taking any SGLT-2 inhibitor should remain vigilant for signs of increased tenderness, sores, ulcers, and infections in the lower extremities.
Immediately notify a medical professional if such symptoms appear. The FDA has warned of several severe side effects including Fournier’s Gangrene infection.
Other serious complications of SGLT-2 medications may include the following:
• Renal Failure
• Kidney Failure
• Heart Attacks
• Fournier’s Gangrene
• High amounts of potassium in the blood
• Serious urinary tract infections
• Low blood sugar when combined with other diabetes medicine
• Yeast infections
• Bone fractures
• Increased cholesterol
By taking the initiative and filing drug injury and contamination lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer and patient safety depends largely on making sure pharmaceutical companies operate within the law and within ethical boundaries.
Some diabetes dugs have been found to be contaminated with higher-than-acceptable levels of the nitrosamine impurity N-nitrosodimethylamine (NDMA). NDMA has been detected in certain metformin products used to treat type 2 diabetes, according to the FDA.
There are several diabetes drugs on the market that can serve as an alternative to Metformin. Talk to your physician about your healthcare options, and to discuss the risks of each pharmaceutical.
There are some concerning health risks with taking contaminated drugs, and Metformin has been recalled due to cancer risks.
In high doses, NDMA contamination may cause liver, lung, and kidney problems, according to studies. The World Health Organization (WHO) says it may also lead to gastric or colorectal cancer.
If you have taken Metformin for more than three months and have been diagnosed with cancer, contact The Lyon Firm for a free case review.
Following a drug-related injury, The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against pharmaceutical companies to obtain just compensation under the law.
Nationwide Consolidation in U.S. District Court, E. Dist. of LA.
This pharmaceutical case involved claims that the blockbuster painkiller was causing heart attacks and strokes in consumers. The FDA ultimately recalled the medication. Merck settled the outstanding Vioxx claims for $4.85 billion following multiple trials in both state and federal courts. Joe Lyon was co-counsel in a number of individual claims that were successfully resolved in the federal MDL. The funds received for Lyon Firm clients helped several elderly clients with additional medical and home health care.
Nationwide Consolidation in Civil Complex Litigation Center Philadelphia, PA.
A pharmaceutical case involving claims that a popular surgical medication was causing kidney failure and death. The FDA recalled the medication in question, but not before thousands of patients died due to related complications. Bayer resolved certain claims for $60 Million for patients who suffered kidney failure and death as a result of using the drug Trasylol. Joseph Lyon represented a widow from Kentucky whose husband died due to kidney failure following the administration of Trasylol. The recovered funds assisted the surviving family members in resuming farming operations.