One of the emerging issues in defective drug lawsuits is the fact that many popular drugs have been found to contain carcinogens. Some of these medications have been recalled from the market as they may contain unsafe levels of a contaminant. For some classes of drugs, this has resulted in the entire class of medications being pulled from the market and scores of product liability lawsuits from some consumers who claim that their cancer was caused by the allegedly defective drug. Now, the widely used diabetes metformin has also been found to contain this substance, sparking calls for a recall of all of the medications that contain this drug. However, the FDA has not recommended a recall of metformin at this point.
What Is NDMA and How Is it Harmful?
The specific contaminant that metformin was found to contain is called NDMA. This is also known as N-Nitrosodimethylamine. It is an organic chemical that is a byproduct of industrial processes. It can occur either intentionally or unintentionally. NDMA can be contained in anything from drinking water to rocket fuel to cured meats. At low levels, it is not necessarily harmful to human beings although it is a known carcinogen to lab animals. However, as the rate of NDMA crosses a threshold, it can potentially cause cancer in human beings.
NDMA Has Been Found in Several Popular Drugs
NDMA in drugs emerged as an issue within the last couple of years, First, the popular blood pressure drug valsartan was found to contain potentially harmful levels of NDMA, In the case of valsartan, there was an impurity that was introduced into the manufacturing process in China and India, where the drugs were made. This resulted in numerous lawsuits against the makers of the drug.
Then, the popular heartburn drug Zantac and other medications containing ranitidine were also found to contain NDMA and were all recalled. Here, the suspicion is that ranitidine is a naturally volatile compound and becomes NDMA on its own. While it is still thought that the levels of NDMA in ranitidine are not very high, there have still been lawsuits filed by plaintiffs who allege that the medications were responsible for their cancer.
The recent discoveries that many popular drugs may contain a carcinogen has sparked an evaluation of other types of medications on the market to ascertain their safety. Now, metformin is the most recent drug to be discovered to contain NDMA. This came after the FDA decided to test some diabetes drugs after other drugs made outside of the U.S. were found to contain NDMA.
Now, NDMA Has Been Found in Metformin
Metformin is a popular form of diabetes drug that is used to treat type-2 diabetes. There are numerous brand names of metformin which include Glucophage, Glucophage XR, Fortamet, Glumetza, and Riomet. Just Glucophage alone has sales of roughly a billion dollars each year.
In this case, the FDA released an alert about metformin on February 3. This informed the public that the regulator posted the laboratory test results from metformin. At the time, the FDA informed the public that the test results indicated that metformin contained somewhere between no to low levels of the contaminant. According to the FDA, the amount that was found did not exceed the daily limitation on NDMA intake. While humans should not necessarily seek to consume NDMA, levels below a certain amount are not considered dangerous. The FDA stated that the levels found did not merit a recall and that it would continue to monitor the situation. Patients and doctors were encouraged to report any side effects through the Adverse Event Reporting Program.
The FDA Has Not Advised a Recall of Metformin
As of this writing, NDMA remains on the market notwithstanding the laboratory results that show the presence of NDMA. This decision is now drawing some criticism due to the possible dangers for consumers. When the FDA first announced the presence of NDMA in ranitidine, it also did not advise a recall and it said that the levels were low. However, shortly afterwards, testing began to indicate that the level of NDMA was higher than initially thought. As a result, a steady stream of manufacturers began to take their products off the market.
Now, other test results are beginning to show that metformin has higher levels of NDMA than originally thought. The online pharmacy Valisure performed its own tests on metformin and found a high level of NDMA. In some tests, the metformin contained more than ten times the allowable daily intake of NDMA. As a result, Valisure is pressing for a recall of the drug, just as it advocated for a recall of Zantac. However, the FDA indicated after it released the initial test results that it has no plans to recall metformin and it has not budged from that stance.
This is notwithstanding the fact that certain brands of metformin have been voluntarily recalled in Canada, although the Canadian regulator is gaining a reputation and being more proactive than the FDA. In addition, the Singapore regulator also found levels of NDMA higher than allowed in metformin and recalled some of the brands of metformin from the market. The European Medicines Agency is also urging manufacturers to test their own products. However, this would not be the first time that the FDA would be out of step with more vigilant European regulators.
It is unclear what the next steps, if any, will be with regard to metformin. It took several months for momentum to build for a recall of ranitidine and valsartan. However, as of now, Valisure is the only major mover fighting for the recall of the drug and there is not the momentum present in the U.S. that would spark a major recall.
If you have taken metformin and have now been diagnosed with cancer, you should reach out to an attorney to learn your legal rights. The attorneys at Sadaka and Associates can help you. Call us today to schedule for free initial consultation.
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