If you take this medicine, call your doctor now, FDA warns
The tablets contain levels of "impurities above acceptable daily boundaries, according to the FDA.
That you take aOver-The-Counter Ibuprofen for pain or tabletprescribed by your doctor For a long-term condition, your bank on the medications you consume to make you feel better. Unfortunately, in some rare cases, the pills you are taking can have the opposite effect, which is the case with a drug that the Food & Drug American Administration (FDA) justannounced a reminder of. Continue reading to find out if you can be affected by the last prescription reminder.
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An antidiabetic drug has been recalled.
More than 1 to 10 people in the United Statesdiabetes, According to the latest data from the Centers for Disease Control and Prevention (CDC). Although there are manyRecommended lifestyle changes For those who have common condition, many people with type 2 diabetes take a type of drug called Biguanides to control high blood sugar. According to Healthline, theBiguanide's most common type is metformin. And now, a company recalled its metformin medicine, the FDA announced on June 11.
Viona Pharmaceuticals Inc. voluntarily removes two lots of prolonged metformin hydrochloride from 750 mg tablets. The lots of the metformin in question, which have been distributed throughout the country, contain Number of NDC 72578-036-01, include the M915601 lot number, and have the expiry date October 2021. The tablets are themselves white. broken white, uncoated, and have the letters "Z" and "C" on one side and the number "20" on the other.
The drug contains high levels of a carcinogenic agent.
Metformin has been recalled because of "rate of nitrosodimethylamine impurities (NDMA) above acceptable daily limits. »
In the opinion published by the FDA, Viona Pharmaceuticals explains that "NDMA is classified as probable human carcinogen (a substance that could cause cancer) according to the results of the laboratory tests. »
According to the American environmental protection agency, "NDMA is a semivolatil organic chemical which is formed in industrial and natural processes. It is classified as carcinogen B2, which means that it is probably at the origin of cancer to man, such as viona pharmaceutical notes.
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Patients who take the drug concerned should communicate with their doctor.
Viona Pharmaceuticals Inc. has not received reports of adverse events on health at the time when the metformin recall was published on June 11.
The reminder announcement affirms that patients who have received the affected Metformin tablets "are invited to continue to take their medications and contact their doctor for advice on alternative treatment. In fact, according to the FDA, "it could be dangerous for patients with this serious disease tostop taking their metformin Not to mention their health professionals first ".
Viona Pharmaceuticals advises its customers by email and by mail and for the return arranged all the tablets recalled. Consumers who have questions about the reminder can call the recall processor Eversana Services of Science Life at 888-304-5022, from Monday to Friday 8:00 pm CT. Health issues should contact Viona Pharmaceuticals at 888-304-5011, Monday to Friday, 8:30 5.00 pm and.
You can alsoContact the FDA online or by phone at 800-332-1088 to report an adverse reaction to the metformin in question.
This is not the first Time Metformin tablets had this problem.
In May 2020, the FDA recommended that some pharmaceutical companies that Metformin Make Prolonged Liberation Tabletsremember Due to "unacceptable NDMA levels. »
Many companies, includingAmneal Pharmaceuticals,Teva Pharmaceuticals,Apotex Corp,Pharmaceuticals granules,Pharmaceuticals Lupine,Pharmaceuticals Bayshore,MARKSANS PHARMA LIMITED,Sun Pharmaceutical Industries, andNOSTRUM LABORATORIES"Have their prolonged release pills from the METFORMINE of the market since this recommendation of the FDA, all due to the high levels of NDMA.
"The FDA has established strict standards for safety, efficiency and quality, and the Agency makes every effort on scientific basis and data to help maintain the security of drug supply United States, »Patrizia Cavazzoni, MD, Acting Director of the FDA Evaluation and Research Center at the time, said in a statement. "Now that we have identified some metformin products that do not meet our standards, we take action. As we have done since the identification of this impurity, we will communicate as new scientific information becomes available and will become available and become available Additional measures, if appropriate. "
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