Recently, a number of medications have been recalled due to the presence of a possible carcinogen called NDMA. These concerns have impacted drugs such as Valsartan and Zantac as there is still uncertainty over the amount of carcinogen in the drug. Now, these same problems are now possibly affecting the diabetes drug metformin. The FDA is investigating the possibility that this drug too could contain NDMA. Regulators in other countries have ordered the recall of some medications that contain metformin over these concerns. Currently, there has been no further word from the FDA over the possible contamination.
Many Medicines Are Found to Contain NDMA
Over the past two years, there has been a sustained push to investigate medications for the possible presence of this carcinogen. Valsartan was recalled from the market and those who make its products were sued because NDMA was introduced to the product due to a manufacturing impurity. In 2019, medications that contain ranitidine, such as Zantac, were all recalled because of the presence of NDMA. With ranitidine, the speculation is that there is an inherent instability in the substance that causes it to produce NDMA on its own. While the initial tests have shown that the level of NDMA is not significant enough to cause cancer, subsequent tests have found higher levels of the impurity.
Now, in an effort to detect NDMA in other drugs, the FDA is now examining many other medications to detect the same problem. There is a possibility that metformin will be subject to the same recalls as the other medications depending on what the FDA finds. As of this writing, the FDA has not announced any results of its investigation.
What Is Metformin?
Metformin are tablets that are taken orally to control the blood sugar in those who suffer from type-2 diabetes. For some patients, metformin is part of a regimen of treatment that includes insulin, diet and exercise. There are multiple brands of metformin that include Glucophage, Glucophage XR, Glumetza, Riomet, and Fortamet. There are roughly 80 to 90 million prescriptions of metformin that are written and filed each year.
NDMA Is a Contaminant that Can Cause Cancer
NDMA is a contaminant that people are exposed to at low levels on a daily basis. It is found in many foods and the water supply. At low levels, NDMA does not pose a risk for cancer. It is only when the exposure exceeds the maximum daily limit that it becomes a danger. It is a byproduct of chemical reactions and can occur naturally based on certain reactions of substances. However, NDMA can become dangerous when it crosses the acceptable level. For example, one tablet of Valsartan was found to contain 20 times the acceptable level of NDMA. This was a medication that was taken daily. As a result, there are not thousands of Valsartan lawsuits that have been filed against the makers of the medication alleging that the medication caused their cancer.
Metformin has Been Found to Contain NDMA
First, regulators in other countries found that metformin medications contained NDMA. Singapore’s Health Sciences Authority tested 46 different metformin products and found NDMA in some of them, As a result, it required a recall for three out of 46 products that contain metformin. The European Union’s regulator also asked companies to test metformin for traces of NDMA. As of now, the EUs’ regulator has described the risk as very low and instructed patients to keep taking their medications in the interim. Nonetheless, it is difficult to completely assure the public that there is no risk from NDMA given the fact that it can cause cancers at certain levels.
The FDA Is Investigating
In the wake of the Singapore findings and the steps taken by the EU, the FDA has announced that it too is investigating. Janet Woodcock, M.D., the director of FDA’s Center for Drug Evaluation and Research issued a statement on behalf of the FDA on December 5. The statement acknowledged the regulator’s efforts to further consumer safety in the wake of findings that several other drugs contained NDMA. The FDA stated that it was also aware of the reports that other countries had found low levels of NDMA is certain metformin products.
The FDA stressed that not all levels of NDMA in a medication are necessarily dangerous. There is a daily NDMA intake limit of 96 nanograms. The FDA indicated that it was currently investigated the NDMA levels to see if they were above that level. At the time of the statement, the FDA said that there were no recalls of metformin products at that time. However, if high levels of metformin would be found, the FDA would order a recall of any product that had a higher than acceptable level.
In general, the fact that a medication is found to contain NDMA is not the end of the inquiry. The FDA will then try to figure out where the NDMA comes from given that there are several different ways that medication could become contaminated. NDMA can emanate from the manufacturing process, the medication itself or the packaging of the medication. In its testing, the FDA can distinguish the cause of the NDMA as its processes have become more advanced. As of now, no recalls of any metformin products have been issued.
Currently, the Singapore recalls are the only ones that have come out for metformin. Other regulators have found that the levels of NDMA in metformin are acceptable. At this point, the biggest danger to patients is stopping to take metformin without consulting with a physician. Nearly all physicians would advise their patients to continue taking the drug until the FDA advises otherwise. However, if you insist on not taking metformin any longer or the news from the FDA about the NDMA contamination worsens, there are alternate diabetes medications available to take.
The regulator has promised to communicate any findings about metformin. There have been no communications from the FDA after the initial statement that the regulator was investigating.
Learn more Drug Safety News.