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Recall on Drug to Treat Type-2 Diabetes

June 11, 2020

Pharmacy Working with Patients Prescribed Recalled Extended-Release Metformin

MSU Health Care Pharmacy has received a recall on extended-release (ER) Metformin formulation, a medication commonly prescribed to treat elevated blood sugar levels in patients with type-2 diabetes. The FDA laboratory testing has discovered levels of the carcinogenic ingredient, nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit in several ER Metformin formulations.

NDMA is commonly found in water and foods including cured and grilled meats, dairy, produce, and vegetables. Everyone is exposed to some levels of NDMA. The FDA and the international scientific community do not anticipate it to cause harm when ingested at low levels. However, NDMA impurities above the acceptable intake limit may increase cancer risk, but short-term exposure is not expected to increase risk.

Currently, both Apotex Corp and Amneal Pharmaceuticals have issued a voluntary recall of its Metformin ER tablets. The FDA has contacted five firms and recommended that they voluntarily recall their products. The FDA continues to work with manufacturers to ensure proper testing and to prevent shortages. FDA testing has not shown NDMA in immediate release (IR) Metformin products.

The agency is working with the manufacturers of the recalled tablets to identify the source of the NDMA impurity. Additionally, the agency is asking all manufactures of Metformin containing ER products to assess the risk of excessive NDMA in their products and to test each batch prior to its U.S. market release.

The FDA is taking a systemic approach in identifying drugs with nitrosamines above acceptable intake limits so that they can be removed from the market. With improved technology, the detection of even trace amounts of impurities is possible. The FDA is collaborating with international drug agencies to investigate NDMA drug sources and impurities.

What MSU Health Care Pharmacy is Doing:

  • Communicating in person to all individuals prescribed Metformin who present at our pharmacy.
  • Communicating with our affected patients identified by a lot number-specific report.
  • Alerting MSU Health Care locations of the recall and steps we are taking to ensure patient safety.
  • Discontinuing dispensing of the recalled lot of ER Metformin.

Advice for Patients

In alignment with FDA guidelines, MSU Pharmacies is recommending all patients:

  • Continue taking the recalled medication until you have an alternative treatment, because the risk of harm to your health may be higher if the treatment is stopped immediately without any alternative treatment.
  • If you believe you have a recalled prescription, contact your pharmacist or your provider who can advise you about an alternative treatment.

Advice for Providers

  • Be aware that service locations that prescribe Metformin may receive a higher patient call volume due to the recall.
  • As of now, it is recommended that patients continue taking their Metformin until a replacement is prescribed.
  • If necessary, patients can be prescribed an IR Metformin as both IR and ER formulations are approved to treat type-2 diabetes, alongside a healthy diet and exercise routine. Both IR Metformin and ER Metformin are inexpensive, safe, cause healthy weight loss, and can reduce the risk of cardiovascular events.
  • Other options are also available for patients; please contact the pharmacy for consultation at 517.353.4930 Mondays-Fridays from 7:30 a.m. to 6:00 p.m.

For more information, contact the FDA at  888-INFO-FDA.

 

References:

FDA news release. FDA alerts patients and health care professionals to nitrosamine impurity findings in certain Metformin extended-release products. May 28, 2020. Available from: https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-Metformin

Christine Blank. First big Metformin product recalled, more on the way. FDA. May 29, 2002. Available from: https://www.drugtopics.com/latest/first-big-Metformin-product-recalled-more-way

Kari Oakes. FDA  recalls some ER Metformin for NDMA impurity. May 29, 2020. Available from: https://www.raps.org/news-and-articles/news-articles/2020/5/fda-recalls-some-er-Metformin-for-ndma-impurity