Metformin ER (Extended Release) is a popular Diabetes medication that is currently in the process of being recalled due to higher than FDA acceptable levels of NDMA, a cancer-causing impurity.
According to the FDA website, a statement made in December 2019, by Janet Woodcock, M.D., who is the director of the FDA’s Center for Drug Evaluation and Research, was documented. In the statement, Dr. Woodcock reported “.. impurities found in (the) Diabetes drug outside of the U.S.”. In regards to Dr. Woodcock’s statement, she also reported that the FDA was investigating the “.. presence of genotoxic impurities, called nitrosamines, in some types of drugs.” In the investigation, that lasted for over a year and a half, it was found that some drugs were found to contain small amounts of those nitrosamines like N-Nitrosodimethylamine (or NDMA, the carcinogenic substance found in Metformin). In the statement, Dr. Woodcock says that the medication, Metformin, was within the acceptable amount for the United States but there would be testing done to reach a conclusion. On May 28th, 2020, the FDA had a press release, alerting patients and health care professionals about the NDMA findings in certain Metformin Extended-Release products. Fortunately, a short time later, pharmaceutical companies began to voluntarily recall their batches of Metformin ER. It is important to note that with further FDA testing, there isn’t any shown NDMA in Metformin Immediate Release (IR), which is the most commonly prescribed type of Metformin.
N-Nitrosodimethylamine, or NDMA for short, is a common and naturally occurring contaminant found in water and foods like cured or grilled meats, dairy products, and vegetables. It is also a probable human carcinogen when taken in large quantities or over a long period of time. This is not the first time medication has been recalled due to NDMA. Medications like Zantac and Losartan have been recalled as well for their quantities of NDMA present.
According to the FDA’s website, there have been a total of 16 laboratories that have voluntarily recalled the extended-release Metformin. Most recently, in January of 2021, Nostrum Laboratories recalled the medication.
If you or a loved one have been taking Metformin ER, please consult with your doctor right away to find a safer alternative. It is important to note that it can be dangerous for patients with Diabetes to suddenly stop taking Metformin without first talking to their doctor. According to the FDA, it is recommended to continue the use of Metformin until a safer choice is provided because stopping “cold turkey” can worsen actualized symptoms.
Boesen Law always remains vigilant so you don’t have to. If you or someone you know have taken Metformin and needs legal representation, please do not hesitate to call us at (303) 999-9999 or visit our website: http://www.boesenlaw.com. We are always here to help.
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