Diabetes Drug Recalled: What You Should Know

If you live with Type 2 Diabetes, you rely on medications to help your body make the insulin you need and regulate your blood sugar levels.

When you take such medications, you expect them to be safe. And yet, unfortunately, not all of the drugs on pharmacy shelves are safe. The U.S. Food and Drug Administration (FDA) recalls thousands of drugs each year, with one of the most recent being a common drug used to treat diabetes.

Several Metformin Products Recalled

The FDA recently published a recall for certain metformin hydrochloride extended-release tablets sold under the brand name Time-Cap Labs, Inc. This recall is due to the high levels of NDMA found in the drugs meant to help regulate glucose levels.

Marksans Pharma Limited, the manufacturer, recalled this product earlier in the summer but expanded the recall on October 5. Additionally, it is critical to note that tests found several other metformin products also contained NDMA.

What is NDMA?

N-nitrosodimethylamine (NDMA) is a contaminant found nearly everywhere in the environment, from the food we eat to the air we breathe. The Agency for Toxic Substances and Disease Registry (ATSDR) states that although it does not survive long in the environment, it can often persist in products such as tobacco and pesticides – as well as drugs.

Exposure to NDMA can cause significant liver damage, but it is also considered a “probable human carcinogen.” There are not yet any cases confirming NDMA causes cancer in humans, but it does in animals.

But how does this dangerous contaminant form in drugs? There are a few ways this happens, including:

• Unintentional formation during the manufacturing process
• How or where drugs are stored, causing NDMA levels to rise beyond FDA limits

The FDA still has not determined the cause of NDMA in metformin products. Therefore, they cannot determine the risk individuals who took this medication face.

What should you do?

If you take metformin for your Type 2 diabetes, there are a few critical steps you should take:

• Check your medication and compare it to the recalled drugs listed on the FDA’s website
• If your medication is on the list, you should contact your doctor as soon as possible to discuss other treatment options
• Keep up to date with information about the recall and the FDA’s investigation
• Stay vigilant and know your rights

Manufacturers should ensure the drugs they sell are safe, but you should make sure you pay attention to recalls to reduce the risk you face.