People with pre-diabetes can delay or even prevent the onset of Type 2 diabetes by learning to make healthy choices and monitor blood sugar levels (Photo: File photo)
Two pharmaceutical companies issued voluntary recalls Monday for metformin, an anti-diabetes drug, due to high levels of a cancer-causing compound, according to a release from the U.S. Food and Drug Administration.
Metformin is used to treat type 2 diabetes, according to Mayo Clinic, and is distributed under the following brand names: Fortamet, Glucophage, Glucophage XR, Glumetza and Riomet.
Marksans Pharma and Sun Pharmaceutical Industries are not the first companies to recall the drug after the FDA released an alert in May, stating agency laboratory testing of several lots of extended-release (ER) metformin revealed levels of N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit.
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Consuming up to 96 nanograms of NDMA in a day is considered reasonably safe, according to the FDA. But the Nitrosamine impurity may increase the risk of cancer if one’s daily exposure exceeds that limit.
“We understand that patients may have concerns about possible impurities in their medicines, and want to assure the public that we have been looking closely at this problem over many months in order to provide patients and health care professionals with clear and accurate answers,” Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in the May 28 release.
“Now that we have identified some metformin products that do not meet our standards, we’re taking action. As we have been doing since this impurity was first identified, we will communicate as new scientific information becomes available and will take further action, if appropriate.”
Since then, more than 10 companies have issued recalls on ER metformin tablets:
- Amneal Pharmaceuticals.
- Apotex Corp.
- AVKARE Inc (Amneal).
- Bayshore Pharmaceuticals, LLC.
- Granules Pharmaceuticals.
- Lupin Pharmaceuticals.
- Marksans Pharma Limited.
- PD-Rx Pharmaceuticals (Amneal).
- PD-Rx Pharmaceuticals (Marksans).
- Sun Pharmaceuticals Industries, Inc.
- Teva Pharmaceuticals.
The FDA’s testing has not found NDMA in immediate release (IR) metformin products, which is the most commonly prescribed type of metformin. The agency will continue to provide updates and announce additional metformin recalls as necessary.
The FDA states patients taking recalled ER metformin should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option.
“It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional,” the FDA wrote in its Monday release.
Dr. Shailendra Patel, director of the UC Division of Endocrinology, Diabetes and Metabolism and a UC Health physician, has a message for patients who use metformin: do not quit the drug cold turkey.
“Don’t panic,” Patel said. “Just have a nice discussion with your provider. And make sure that if the medication’s the only thing that’s controlling your disease, don’t stop it. Just go in and ask and say, ‘what are my alternatives?’ “
We all are exposed to carcinogens every day, Patel said. They’re in the foods we eat: beer, bacon, cheese, etc. Patel says the highest level of carcinogenic molecules that you can find is when you barbecue; but, we continue to grill meats.
“Because most of the time, our bodies really can cope,” Patel said.
The drugs should certainly have been recalled, Patel said; once the agency discovered the higher levels, they needed to take care of it.
And Patel admits that other doctors may feel differently.
“But I don’t know that people have been harmed, or are likely to be harmed by this,” Patel said.
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