- 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. voluntarily revoked 23 lots of prolonged-release metformin hydrochloride tablets due to the presence of the probable carcinogen NDMA.
- The pharmaceutical company also recalled two lots of metformin in June 2021, citing exactly the same carcinogenic impurity.
Check your medicine cabinet: Viona Pharmaceuticals, Inc. recalls 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 has an impact on 23 lots of Viona’s metformin, which is likely to contain unacceptable levels of the N-nitrosodimethylamine (NDMA) impurity, according to the Food and Drug Administration’s FDA’s January 12 announcement. NDMA is an environmental pollutant classified as a probable human carcinogen, says the FDA. Testing revealed the impurity in one lot, and the statement indicates that the rest are likely to be affected as well. No adverse events have been reported yet.
The 23 recalled metformin lots are packaged in 100-pill bottles and have expiration dates between June 2022 and January 2023. They have been shipped to distributors nationwide. You can find the complete list of revoked lots here. Multiple pharmaceutical companies manufacture metformin, but this recall only affects Viona’s products.
Exposure to high levels of NDMA can cause liver damage, the Environmental Protection Agency (EPA) warn. Symptoms of overexposure include headache, fever, nausea, jaundice, vomiting, cramps, enlarged liver and dizziness, the EPA explains. It has been shown to cause tumors in rodents, which means that it is also likely to cause cancer in humans.
Metformin is often used by type 2 diabetes patients to help manage the amount of glucose in the blood, which reduces 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 is often used in conjunction with lifestyle changes, including diet and exercise.
The repeal of January 12 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 warning. Viona recalls two lots of the same metformin medication in June 2021, also with reference to NDMA impurities.
If you believe you have taken the recalled metformin, the FDA encourages you to continue taking your medication, as the consequences of discontinuation may be worse than possible exposure to NDMA. Instead, you should first contact your doctor and discuss alternative treatments. Viona recommends that the pills be returned to its recall center.
You can contact Viona at 888-304-5011 with questions. If you experience any adverse effects associated with the recall, you can report it to the FDA using this form.
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