The FDA has announced the recall of one brand of a popular type 2 diabetes drug, metformin, over a potentially cancer-causing impurity.
Viona Pharmaceuticals, Inc. is voluntarily recalling 23 lots of Metformin Hydrochloride Extended-Release Tablets due to the presence of the probable carcinogen NDMA.
The pharmaceutical company also recalled two lots of metformin in June 2021, citing the exact same carcinogenic impurity.
Check your medicine cabinet: Viona Pharmaceuticals, Inc. is recalling several lots of the popular medication Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (often used to treat type 2 diabetes) over a potentially cancer-causing impurity.
The recall impacts 23 lots of Viona’s metformin drug, which likely contains unacceptable levels of the impurity N-nitrosodimethylamine (NDMA), per the Food and Drug Administration’s (FDA) January 12 announcement. NDMA is an environmental contaminant classified as a probable human carcinogen, the FDA says. Testing revealed the impurity in one lot, and the statement indicates that the rest are likely affected, too. No adverse events have been reported yet.
The 23 recalled metformin lots are packaged in bottles of 100 pills and have expiration dates between June 2022 and January 2023. They were shipped to distributors nationwide. You can find the full list of recalled lots here. Multiple pharmaceutical companies manufacture metformin, but this recall affects only Viona’s products.
Exposure to high levels of NDMA may cause liver damage, the Environmental Protection Agency (EPA) warns. Symptoms of overexposure include headache, fever, nausea, jaundice, vomiting, cramps, enlarged liver, and dizziness, the EPA explains. It’s been shown to cause tumors in rodents, meaning it also likely causes cancer in humans.
Metformin is often used by type 2 diabetes patients to help manage the amount of glucose in the blood, decreasing the amount of sugar absorbed from food and produced in the liver, according to the National Institutes of Health (NIH). It also increases the body’s response to insulin. Although metformin can be taken alone, it’s frequently used alongside lifestyle changes, including diet and exercise.
The January 12 recall appears to be a smaller version of a previous recall announced by Viona on December 28, when 33 lots of metformin were called out; only 23 lots are mentioned in the most recent alert. Viona recalled two lots of the same metformin medication in June 2021, too, also citing NDMA impurities.
If you believe you have been taking the recalled metformin, the FDA urges you to keep taking your medication, as the consequences of stopping could be worse than potential exposure to NDMA. Instead, you should first contact your doctor and discuss alternative treatments. Viona recommends returning the pills to its recall center.
You can contact Viona at 888-304-5011 with questions. If you experience any adverse effects related to the recall, you can report them to the FDA using this form.
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