Understanding the metformin recall

With so much publicity surrounding the recent voluntary recall on metformin, determining next steps can be difficult. To help alleviate the confusion, Hendrick Professional Pharmacy Manager Greg Young, has simplified information on the recall of this prescription drug used to control high blood sugar.

Metformin is not the problem. Metformin, itself, is safe. The Federal Drug Administration (FDA) is concerned with an impurity that has been found in some batches of the drug. The impurity could be present for various reasons, so the FDA is taking these proactive steps to ensure the safety of individuals taking the drug.

When levels of the impurity, known as NDMA, are beyond acceptable, it’s possible that long-term exposure can increase health risks, including risks for certain cancers. 

Several months ago, NDMA contamination led to a similar recall for heartburn medicines, like ranitidine and nizatidine. NDMA is a common contaminant found in water and foods including cured and grilled meats, dairy products and vegetables. Experts agree that low-level exposure does not cause harm.

Not all metformin is affected. Presently, only certain brands of the extended-release formulation of metformin are affected by the recalls. Immediate-release metformin has been tested by the FDA, and has not proven reason for concern due to NDMA. 

The recalls are voluntary. The FDA has requested that certain pharmaceutical companies voluntarily recall metformin. A voluntary recall occurs when the FDA has found problems that need to be corrected, but there is no immediate danger of serious harm to the general public.

Do not stop taking metformin. Individuals should continue taking metformin. DO NOT discontinue use until a healthcare provider is consulted.

Talk to your pharmacist. Ask your pharmacist to help identify what formulation and what brand of metformin you are taking. He/she will be able to determine if the brand has been recalled.

Talk to your doctor. Right now, we still don’t know if the voluntary recall will be widespread. If metformin becomes temporarily unavailable, individuals should talk with their doctors about next steps or possible medication adjustments. It’s important to stay on metformin until you talk with your doctor.

For more information on the voluntary metformin recall, visit https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts and search for metformin.