The United States Food and Drug Administration is investigating a common diabetes drug over concerns that it may contain a potentially cancer-causing chemical.
The diabetes drug in question is known as Metformin; which is, in fact, the most popular treatment for patients dealing with Type 2 diabetes. It is also quite often prescribed as an initial treatment for Polycystic Ovary Syndrome patients who also have insulin resistance.
Now, it is important to understand that the investigation only began after some metformin medications distributed in other countries were found to contain traces of N-Nitrosodimethylamine, which is also known as NDMA. The FDA says that levels of this chemical, NDMA, in those medicines fall within the range of what otherwise naturally occurs in foods and even some water sources.
Accordingly, the United States FDA Center for Drug Evaluation and Research director Janet Woodcock comments, “While we are aware that some regulatory agencies outside the US may be recalling some metformin drugs, there are no metformin recalls affecting the US market at this time. The FDA is investigating whether metformin in the US market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms.”
In the meantime, experts recommend that patients who are currently taking metformin should continue to do so. After all, it can be dangerous for any patient treating a serious condition to suddenly stop taking a prescribed medication. It is particularly dangerous in this case because Type-2 diabetes patients do not have an alternative that can be used in place of metformin to help regulate blood sugar while the investigation continues.
You may recall that NDMA had been found, previously, in heartburn and blood pressure medications; and those medications were quickly recalled by the FDA. As such the agency is now expanding its testing requirements for medications of this nature in order to ensure that NDMA—beyond the acceptable daily intake limit—does not continue to show up in these medications.
Woodcock goes on to advise, “These investigations take time. We understand that these issues affect patients’ health and well-being in many ways, and the FDA’s goal is to provide patients and health care providers as much clarity and as many answers as possible to inform the health care decisions.”
As with any recall, particularly when it comes to medicine, representatives are available to discuss the issue. In this case, you can call the FDA at 888.INFO.FDA for more information.