In May 2020, the FDA announced that higher NDMA levels were an issue in the extended release versions of metformin. As a result, the FDA said that it would work with five manufacturers for a voluntary recall of their drug. Many types of drugs in the United States have been recalled recently due to the same exact problem. They have each been found to contain a substance called NDMA that is a possible carcinogen when humans are exposed to it in large enough quantities. These problems have affected medications from the blood pressure drug valsartan to the heartburn medication Zantac. Many of these drugs have been pulled from the market completely. Even if there have not been diagnosed cases of cancer that have been connected with these medications, manufacturers are still acting out of an abundance of caution to pull these drugs.
*We are currently not accepting Metformin lawsuits
What Is NDMA and Why Is it Harmful?
In order to understand the dangers that patients who have taken metformin face, it is important to know a little more about NDMA. Its full name is N-Nitrosodimethylamine. It is a yellow oil and a volatile substance. This is not necessarily a naturally-occurring substance, but it can form naturally. It is also a chemical that forms after an industrial process. For example, in the case of Zantac, NDMA forms over time as the chemical composition of the active ingredient is inherently unstable. NDMA can also be manufactured and used in other products. One use of NDMA is in jet fuel.
Humans are exposed to NDMA practically every day. It can be found in drinking water and even in some meat products. The everyday levels of NDMA are not necessarily dangerous in themselves. There is a maximum allowable amount of NDMA that humans can be exposed to without it being dangerous. This measure is 0.096 micrograms or 0.32 parts per million. Below these levels, NDMA would not pose much of a danger to humans.
Update-10/12/2020- “The recall of extended-release metformin continues as two more lots of the diabetes drug have been added to the recall list. Kansas City-based Nostrum Laboratories has issued a voluntary recall of two lots of Metformin HCl Extended Release Tablets, USP 750 mg. The addition of Nostrum’s pills come as 76 more lots were flagged in October for a possible cancer-causing ingredient. The FDA announced the previous recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500mg and 700mg tablets.” Web MD
High Exposure to NDMA Can Cause Cancer
Even though NDMA is a common substance, it does not mean that it is safe for unlimited consumption. Higher levels of NDMA exposure can be dangerous. People need to ingest higher amounts of NDMA for a prolonged period of time in order to suffer the side effects. When humans do ingest large amount of NDMA, it is a possible carcinogen. NDMA intake is associated with the following types of cancer:
We emphasize that not everyone who has taken a drug that contains NDMA will eventually develop cancer. However, there is a risk of cancer if you have taken the medication over a period of time. NDMA can build up in your system until it sickens you.
Metformin Is a Drug Used to Treat Type 2 Diabetes
Metformin is a medication that is taken orally that helps control diabetes. It is used for patients with type 2 diabetes. Metformin is the name of the class of medications, and there are numerous companies in this space that each make their own products. The drug is called metformin because it takes its name from the active ingredient of metformin hydrochloride. Metformin is considered the first line of defense for people with type 2 diabetes. It is meant to inhibit glucose production in the liver. Metformin is supposed to cut the amount of sugar that the body produces and absorbs. At the same time, it increases the body’s sensitivity to insulin. This acts as a force multiplier for diabetes patients who take insulin.
Metformin Gradually Lowers Blood Sugar
The drug is not considered a quick fix. However, it will gradually work to lower blood sugar in the body, especially when combined with a program of exercise and dietary change. Patients will take the drug in either tablet or solution form. They could start on 500 mg per day and gradually increase the dosage to 1500 mg.
Metformin comes in both name brand and generic versions of the drug. It is sold under names such as:
- Glucophage XR
There are over a dozen companies worldwide that manufacture metformin products. This is one of the top-selling diabetes products and has been taken by millions of patients both in the U.S. and worldwide.
The FDA Has Tested Numerous Drugs for NDMA
After valsartan was tested and found to have contained NDMA, many other drug products were soon tested on their own for the presence of the possible carcinogen. Nearly all popular drugs have now been looked at for their NDMA content. As a result, many common drugs have now been recalled.
The FDA Finds NDMA in Metformin
Here is the timeline of the FDA’s investigation of metformin, which led to a partial recall of the drug.
- The issue of possible contamination of metformin emerged in December 2019. The first notice that the public received was through a public statement made by the FDA’s Janet Woodcock. Initially, the FDA informed the public that it was aware of reports that metformin was found in drugs overseas, but that it believed that the levels were within the normal acceptable amounts. However, the FDA said that it would continue to investigate.
- In February 2020, the FDA released test results from all the different types of metformin. Some drugs were found not to have any NDMA, However, some drugs were found to have contained 5-10 times the normal allowable limit for daily intake.
- In May 2020, the FDA announced that higher NDMA levels were an issue in the extended release versions of metformin. As a result, the FDA said that it would work with five manufacturers for a voluntary recall of their drug.
- The following companies were subject to the initial recall
- An FDA research paper published in a scientific journal found that unacceptable NDMA levels were present in 16 of the 38 different samples tested by a private laboratory. However, the FDA found that there were lower levels in these medicines than reported by the private laboratory
- Currently, there is more information emerging about NDMA contamination of metformin. Additional companies are announcing recalls.
At this point, we do not quite yet know the extent of the harm caused by metformin damage. One of the major issues is the amount of NDMA ingested and for how long they were exposed to it. Right now, we are still learning more about the seriousness of the problem. Given the dangerousness of NDMA and its carcinogenic effects, there is a statistically significant possibility that there will be numerous cases of cancer tied to the long-term use of the drug.
Contact a Metformin Lawsuit Attorney to File a Lawsuit for Compensation
Currently, there is a class action lawsuit that has been filed on behalf of purchasers of metformin seeking refunds. There is also the possibility that makers of the drug can be subject to product liability lawsuits for selling a defective product and failing to warn the public of the dangers of the drug. If you have taken metformin and have subsequently been diagnosed with cancer, you may be entitled to substantial financial compensation. The drug companies can be made to pay for the damage that their product has done to you. If you have taken metformin and believe that you have been sickened, the first step is to consult a metformin lawsuit lawyer. We can help you file a lawsuit that will get you and your family the compensation that you deserve