Since 2010, the FDA has been investigating the presence of N-nitrosodimethylamine (NDMA) in Metformin, “after several batches of the diabetes drug sold outside the U.S. were found to contain low levels of the substance.” (Healthline.com)
In 2018, the US Food and Drug Administration (FDA) recalled some blood pressure medications due to the drugs containing NDMA.
Ranitidine, a popular medication which reduces acid in the stomach, used for health issues like heartburn, sour stomach, and acid indigestion, was recalled in 2019 because of NDMA.
What is NDMA?
“NDMA is a common contaminant found in water and foods including cured and grilled meats, dairy products and vegetables.” (FDA.gov) Per Dr. Amir Masoud, a Yale Medicine gastroenterologist, “NMDA is classified as a probable human carcinogen, meaning it could potentially cause cancer.” NDMA is not expected to cause any harm when ingested at low levels (under 96 nanograms/day). However, at higher levels, or over long periods of time, the risk of cancer increases.
According to research done on animals, NDMA can cause lung, liver and kidney issues. It can also cause gastric or colorectal cancer, per the World Health Organization (WHO). It has been used to induce cancer in lab rats.
The FDA “stated that there are multiple reasons for the presence of NDMA in drugs…The source of NDMA can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged.” (Healio.com)
On May 28, 2020, the FDA announced that several lots of extended-release (ER) forms of metformin had been found to contain levels of NDMA above acceptable intake limits, and recommended those medications be recalled.
In another press release on June 11, 2020 the FDA announced that five companies had voluntarily recalled certain ER lots of Metformin. Not all metformin is being recalled at this time; only the following specific lots have been recalled:
- Apotex – All lots
- Amneal – All lots
- Marksans (labeled as Time-Cap) – One lot (XP9004)
- Lupin – One lot (G901203)
- Teva (labeled as Actavis) – 14 lots
What is metformin?
Metformin is commonly prescribed for lowering blood sugar in people with type 2 diabetes.
What should you do if you are currently taking metformin?
Do not stop taking any prescribed medications or alter your intake without first talking to your health provider.
Contact your physician to find out whether the specific metformin you are taking has been recalled. Then ask what he/she recommends.
The ER formulation of metformin is normally used for convenience (only requires one pill a day), and/or because it is tolerated better by some patients. So far, no immediate-release formulation has been recalled. Switching to that may be an option for some patients.
Keep an eye/ear out for further recalls.
So far there have been no reports of shortages on Metformin. CVS spokesman Mike DeAngelis said, “We have an adequate supply of non-recalled product to take care of our patients’ needs and will dispense alternate metformin products that have not been recalled”.(PharmacyPracticeNews.com)
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