NDMA Contamination Discovered in Diabetes Drug
In December 2019, the U.S. Food and Drug Administration (FDA) began an investigation into Metformin, a drug commonly used to treat type-2 diabetes. After discovering high levels of N-Nitrosodimethylamine or NDMA – a probable human carcinogen – in some versions of metformin, the FDA urged five pharmaceutical companies to voluntarily recall the drug.
In that same announcement, the FDA also warned diabetes patients and healthcare providers about the cancer risk associated with NDMA contamination in Metformin. This is not the first time the FDA has been forced to issue a formal warning about NDMA contamination in common medications. In April 2020, the FDA asked all manufacturers to recall Zantac (ranitidine) after independent research showed NDMA levels can increase when the drug is exposed to heat.
N-nitrosodimethylamine is present in many of the foods we eat and products we use, and while the human body can safely process trace amounts of this compound, long-term exposure to NDMA may result in serious side effects and even cancer. The International Agency for Research on Cancer (IARC) previously classified NDMA as a probable human carcinogen, finding sufficient evidence that it causes cancer in animals and preliminary evidence that it causes cancer in humans.
In March 2020, private research laboratory and online pharmacy company Valisure announced that it detected high levels of NDMA in certain lots of Metformin and filed a Citizen Petition with the FDA asking them to issue a voluntary recall. Valisure alerted FDA last year of similar NDMA contamination and cancer risks associated with Zantac.
What Does This Mean for Diabetes Patients?
For now, the FDA recommends that diabetes patients continue taking Metformin and consult with their healthcare professional about possible alternatives. However, if you or your loved ones have been diagnosed with cancer after long-term Metformin use, it may be a good idea to contact a skilled attorney with experience representing plaintiffs in complex pharmaceutical litigation.
At Ashcraft & Gerel, our attorneys have been leaders in this area for more than 65 years and have successfully won verdicts in many defective drug lawsuits. We are currently investigating the links between Metformin and cancer and can help you explore your legal options after NDMA exposure.For more information, contact our team at (800) 674-9725. We offer free consultations and are available to assist clients throughout Washington DC, Virginia, and Maryland.