Metformin Recalls After FDA Finds High Levels of NDMA

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Metformin is a drug that is commonly used by diabetes patients. The drug works by reducing the amount of sugar your liver releases into your blood. It also makes your body respond better to insulin. Insulin is the hormone that controls the level of sugar in your blood. It’s best to take metformin with a meal to reduce the side effects. Under normal circumstances the drug’s side effects are limited to heartburn, stomach pain, and gas, however, the FDA found that some brands contained higher than recommended levels of NDMA.

Not all Metformin products have been found to contain this contaminate and patients taking recalled drugs should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional.

Why is Metformin Being Recalled?

Higher-than-acceptable levels of the nitrosamine impurity N-nitrosodimethylamine (NDMA) were detected in certain metformin products used to treat type 2 diabetes, the FDA announced on Thursday. So far only extended release versions of the drug have been found to have these high levels of the carcinogen. At this time immediate release versions of the drug all appear to not be contaminated. So far the FDA is unsure of when the extended release version first became contaminated but is something that they are working to discover.

Is There a Cancer Risk From Taking Metformin?

The FDA does not currently know how long patients may have been exposed to higher NDMA levels. FDA does not expect nitrosamines to cause harm when ingested at or below the acceptable intake limit levels (such low levels of nitrosamines are present in foods in low levels and ingested as part of usual diets) even over a long period of time (such as a 70-year lifespan). Nitrosamine impurities may increase the risk of cancer if people are exposed to them at above acceptable levels over long periods of time, but we do not anticipate that shorter term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer. 

There are additional manufacturers of the metformin ER formulation that supply the bulk of the US market, and their products are not being recalled. The agency will work closely with manufacturers to prevent or reduce any potential impact of shortages. If you believe that you have been affected by cancer do to the use of this drug you should contact a defective product lawyer about your case.

Which Metformin Brands Are Being Recalled?


Quick Answers

What Should I Do If I’m Taking Metformin?

Patients taking recalled metformin should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional.

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