If You Take This Medication, Call Your Doctor Now, FDA Warns
The tablets contain levels of "impurities above acceptable daily limits," according to the FDA.
Whether you're taking an over-the-counter ibuprofen for aches and pains or a tablet prescribed by your doctor for a long-term condition, you bank on the medication you consume to make you feel better. Unfortunately, in some rare instances, the pills you're taking can have the opposite effect, which is the case with one medication that the U.S. Food & Drug Administration (FDA) just announced a recall of. Read on to find out if you could be affected by the latest prescription recall.
A common diabetes medication has been recalled.
More than 1 in 10 people in the U.S. have diabetes, according to the latest data from the Centers for Disease Control and Prevention (CDC). While there are many lifestyle changes recommended for those with the common condition, plenty of people with type 2 diabetes take a type of medication called biguanides to control high blood sugar. According to Healthline, the most common type of biguanide is metformin. And now, one company has recalled its metformin medication, the FDA announced on June 11.
Viona Pharmaceuticals Inc. is voluntarily recalling two lots of metformin hydrochloride extended-release 750 mg tablets. The batches of metformin in question, which were distributed nationwide, contain NDC number 72578-036-01, include batch number M915601, and have the expiration date Oct. 2021. The tablets themselves are white to off-white, uncoated, and have the letters "Z" and "C" on one side and the number "20" on the other.
The medication contains high levels of a carcinogen.
The metformin was recalled due to "levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits."
In the notice posted by the FDA, Viona Pharmaceuticals explains that "NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests."
According to the U.S. Environmental Protection Agency, "NDMA is a semivolatile organic chemical that forms in both industrial and natural processes." It's classified as a B2 carcinogen, meaning it's probably cancer-causing to humans, as Viona Pharmaceuticals notes.
Patients who take the affected medication should contact their doctor.
Viona Pharmaceuticals Inc. had not received any reports of adverse health events at the time the metformin recall was issued on June 11.
The recall announcement says patients who have received the affected metformin tablets "are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment." That's because, according to the FDA, "it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals."
Viona Pharmaceuticals is notifying its customers by email and mail and is arranging for the return of all recalled tablets. Consumers with questions regarding the recall can call the recall processor Eversana Life Science Services at 888-304-5022, Monday through Friday from 8 a.m. to 7 p.m. CT. Those with medical-related questions should contact Viona Pharmaceuticals at 888-304-5011, Monday through Friday, 8:30 a.m. 5:30 p.m. ET.
You can also contact the FDA online or via phone at 800-332-1088 to report an adverse response to the metformin in question.
This isn't the first time metformin tablets have had this issue.
In May 2020, the FDA recommended that some pharmaceutical companies that make metformin extended release tablets recall them due to "unacceptable NDMA levels."
Many companies—including Amneal Pharmaceuticals, Teva Pharmaceuticals, Apotex Corp, Granules Pharmaceuticals, Lupin Pharmaceuticals, Bayshore Pharmaceuticals, Marksans Pharma Limited, Sun Pharmaceutical Industries, and Nostrum Laboratories—have pulled their metformin extended release pills from the market since that FDA recommendation, all due to high levels of NDMA.
"The FDA has strict standards for safety, effectiveness and quality, and the agency makes every effort based on science and data to help keep the U.S. drug supply safe," Patrizia Cavazzoni, MD, the acting director of the FDA's Center for Drug Evaluation and Research at the time, said in a statement. "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."