What You Need to Know About the Latest Metformin Recall
By: Tara Iyer, MD • Posted on November 12, 2020
In the past few years, there has been increasing media coverage over medication recalls. Most recently, the Food and Drug Administration (FDA) and several pharmaceutical companies have initiated a large scale recall on the common diabetes drug metformin. This has left many patients with numerous questions regarding their medication and its safety.
What is a medication recall?
A medication recall is an action initiated by a pharmaceutical company or by the FDA to remove a faulty product from the market in order to keep patients safe.
Why does a drug get recalled?
There are several reasons a drug may be recalled:
- Metformin was recalled because the FDA was alerted to potentially unsafe levels of a nitrosamine impurity known as nitrosodymethylamine (NDMA) in several batches of the medication. (1)
NDMA has been identified as a likely human carcinogen, or substance that can cause cancer, by the International Agency for Research on Cancer (IARC). This classification is based on limited human research and substantial animal research. NDMA is also a known environmental contaminant and can be found in low levels in meat, vegetables, dairy, and even water.
NDMA has also been the reason for several other medication recalls in the past few years, including ranitidine and valsartan.
- Drugs may also be recalled for other safety issues such as mislabeling, contamination, or irregularities in drug potency or consistency.
Am I in danger because I took my metformin?
No. Following the recall, the FDA performed testing on several of the faulty metformin samples and only found very low levels of NDMA. (2, 3) These levels were deemed lower than the acceptable daily intake limit, similar to the levels found in grilled meats. (2)
Should I stop my metformin?
You should check with your pharmacist and/or physician regarding the safety of your medication. If your metformin has been recalled, you should stop the medication and your doctor should send in a new prescription for you so that you may take a safe version of the medicine.
It is important to note that depending on what type of medication you are taking, it is possible it may be more dangerous to stop taking it than to ingest the faulty medication. This may be the case for some vital medications, such as anti-epileptic or cardiac medications. For this reason, it is important that you speak with your healthcare professional as soon as you learn of a recall and prior to stopping your medication.
Can I take metformin in the future?
Yes. Metformin was recalled because of an impurity in several batches of its ingredients. Since this impurity has been identified and pharmaceutical companies can improve their product, future batches of the same medication will be deemed safe by the FDA before they are released into the market.
While metformin is still safe to take, there may be drug recalls in which new scientific data sheds light on the dangers of a medication that was previously thought to be safe. In that instance, your doctor may tell you to stop your medication all together.
Be Strong, Be Healthy, Be in Charge!
- Tara Iyer, MD
Dr. Tara Iyer is a Women's Health Fellow in Cleveland Clinic's Specialized Women's Health Fellowship program. She is a graduate of the Saint Joseph Hospital Family Medicine Residency Program at SCL Health and has numerous student awards and publications.
- Yang, Jingyue et al. “A Cautionary Tale: Quantitative LC-HRMS Analytical Procedures for the Analysis of N-Nitrosodimethylamine in Metformin.” American Association of Pharmaceutical Scientists, vol. 22, no. 89, 2020, pp. 1-8.
- Brennan, Zachary. “NDMA in Metformin: FDA Finds Low Levels in Only 2 of 10 Tested Products.” Regulatory Focus, 3 2 2020, Accessed 28 October 2020.
- Food and Drug Administration. “FDA Updates and Press Announcements on NDMA in Metformin.” Drug Safety and Availability, 2020. Accessed 28 October 2020.
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