FDA Asks Five Companies to Recall Diabetes Drug Metformin
Agency found elevated levels of N-Nitrosodimethylamine, a chemical that could cause cancer, in some extended-release products
The Food and Drug Administration said Friday it has asked five companies to voluntarily recall a widely used diabetes drug after the agency’s testing found higher-than-acceptable levels of a contaminant that could cause cancer.
The drug, metformin, is used to control high blood sugar in type-2 diabetes patients. The FDA said it found the impurity in certain extended-release versions of the drug, not immediate-release versions that are more popular.
Apotex Corp. and Amneal Pharmaceuticals Inc., two of the five companies the FDA contacted, are voluntarily recalling their extended-release metformin tablets. An FDA spokesman declined to specify the other companies because they haven’t formally filed a recall action.
The agency’s move affects a drug that is one of the most commonly used in the U.S. and taken by millions of Americans to help treat diabetes.
“It’s been considered one of the most effective as well as safest medications we have to treat type-2 diabetes,” said Tannaz Moin, an endocrinologist and diabetes researcher at the David Geffen School of Medicine at the University of California, Los Angeles.
The drug doesn’t cause a side effect of low blood sugar, unlike other diabetes treatments, Dr. Moin said.
Doctors usually prescribe extended-release metformin when patients show significant side effects such as bloating, diarrhea and low vitamin B12 levels after taking the regular-release version, Dr. Moin said.
To avoid any health risks from going off the drugs, the FDA advised patients taking the extended-release medicine to stay on it until they consult with a health-care professional about switching to a replacement.
“Now that we have identified some metformin products that do not meet our standards, we’re taking action,” said Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research.
The agency took the action after finding elevated levels of a chemical known as NDMA, short for N-Nitrosodimethylamine.
NDMA is often found in cured and grilled meats, dairy products and vegetables. It isn’t likely to cause harm when ingested at levels beneath the FDA’s acceptable intake limit of 96 nanograms a day in drugs. At higher levels, however, it can raise the risk for cancer, the FDA said.
The agency said in late 2019 that it first learned of the presence of NDMA in metformin products in other countries. By February, the FDA said it had found low levels of NDMA in some samples, but nothing exceeding acceptable limits. The agency said it continued testing.
In March, an online pharmacy called Valisure LLC petitioned the FDA to recall certain metformin products produced by Apotex and Amneal, as well as other companies including Lupin Ltd. and Actavis Pharma, a subsidiary of Teva Pharmaceutical Industries Ltd.
Valisure, of New Haven, Conn., said it had detected high levels of NDMA in the metformin products. In April, the FDA ordered the recall of Zantac and some other heartburn medicines after Valisure had alerted the agency to high NDMA levels.
The FDA said it didn’t ask companies that sell a large portion of extended-release metformin in the U.S. to recall their products. The drug is sold under brands such as Fortamet, Glucophage, Glumetza and Riomet.
The FDA said it has asked metformin manufacturers to test their products for NDMA and not release batches in the U.S. if the chemical is above acceptable levels. The agency is assessing whether the drug recalls would cause shortages and working with manufacturers to limit the effect of any such shortages, it said.
Corrections & Amplifications Actavis Pharma is a subsidiary of Teva Pharmaceutical Industries Ltd. An earlier version of this article misstated Actavis as being owned by AbbVie Inc. (Corrected on May 29.)
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