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Metformin Recalls

By Kam Capoccia posted 07-11-2020 09:57

  

Metformin has been the first line agent for the treatment of type 2 diabetes for many years. Thinking about the hundreds of thousands of people on this drug and even more that will be potentially placed on it, the question of what to do if your medication has been recalled comes to light. Metformin is safe and generally well tolerated, but the recall brings new concerns of shortages and its potential impact.

Recently, metformin extended release (ER) tablets were part of a recall as a precautionary measure due to the limit of NDMA in the products. NDMA, otherwise known as N-Nitrosodimethylamine, is an organic compound that is indirectly made during manufacturing processes. NDMA is indirectly created through reactions with alkylamines – however, it is found in different foods and drinking water as well. NDMA is a known carcinogen in experimental animals and a probable carcinogen to humans, meaning it is linked to the cause of cancer due to its process of modifying DNA. The process of modifying DNA is through the biotransformation by liver microsomal enzymes. To date, no clear studies have shown the quantitative risk of cancer in regards to human subjects, but animal study results support that consumption of NDMA may increase the risk of cancer if people are exposed to them at above-acceptable levels over long periods of time.

Multiple manufacturers such as Apotex, Lupin, Teva, Amneal, and Marksans have voluntarily removed certain lots of their ER metformin products off the shelves. The FDA has been involved with warning patients of the voluntary recalls of the certain lots of extended release formulations of metformin. In addition, the FDA has tested the manufacturer’s products and showed NDMA at the acceptable intake limit in certain lots.

In the community pharmacy, the computer systems record what manufacturer and drug lot are dispensed to each patient for each drug. When a recall occurs, the system searches to find what patients have received that specific manufacturer and drug lot that has been recalled. An automated call is placed to that patient, notifying them of the recall.

Since these manufacturers have voluntarily recalled their products, what should patients do in the meantime? Patients who are currently taking the recalled metformin ER formulation have been advised to continue taking it until consulting with a doctor or pharmacist for an alternative option. Patients are advised to continue on medication therapy as it could be potentially more harmful to the patient to stop taking the metformin. If a patient is concerned that their medication is affected by a recall, they are advised to call their pharmacy. The patients’ local pharmacist will know if the specific batch dispensed to them is part of the recall. If it was recalled, patients should talk with their pharmacist and health care provider to discuss their options. There are other manufacturers and lots of ER metformin that are not affected by the recall that the patient could be switched to.

The FDA has performed testing on metformin immediate release formulations and have not found NDMA contaminants. Safety precautions have been put in place through the FDA for specific testing of NDMA for each batch of metformin. If the testing does not meet the FDA standards, the manufacturers inform the FDA and those batches are not released it to the public. For more information regarding the metformin recall, visit https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

 

References:

  1. FDA Updates and Press Announcements on NDMA in Metformin [Internet]. FDA; 2019 Dec 5 [cited 2020 Jun 19]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin
  2. Public Health Statement [Internet]. Atlanta (GA): Agency for Toxic Substances and Disease Registry; 1989 [cited 2020 Jun 19]. Available from: https://www.atsdr.cdc.gov/toxprofiles/tp141-c1.pdf
  3. Parekh S., Patel T. The Zantac Problem, What is NDMA? [Internet]. Abcnews.go.com; 2019 [cited 2020 Jun 19]. Available from: https://abcnews.go.com/Health/zantac-problem-whats-ndma/story?id=65799147
  4. N-Nitrosodimethylamine: NMDA [Internet]. World Health Organization; 2008 [cited 2020 Jun 19]. Available from: who.int/water_sanitation_health/dwq/chemicals/ndmasummary_2ndadd.pdf

Written by Gianna Comparone, PharmD Candidate Class of 2021, Western New England University, College of Pharmacy and Health Sciences
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