RELATED: This Is When You Should Take Tylenol Instead of Advil, Doctors Say. 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 metformin was recalled due to “levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits.“ae0fcc31ae342fd3a1346ebb1f342fcb 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. RELATED: If Your Doctor Gave You a Sample of This Medication, Don’t Use It, FDA Warns 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. 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.” RELATED: This Medication Could Cause Lower Antibodies After Your COVID Vaccine, Study Says.
title: “If You Take This Medication Call Your Doctor Now Fda Warns Best Life” ShowToc: true date: “2022-12-11” author: “James Werth”
More than 20 million people in the U.S. have a thyroid disorder, the American Thyroid Association (ATA) reports. And in many cases, these thyroid disease are treated with medication. Your thyroid, the butterfly-shaped gland located at the base of the neck, helps regulate many of your body’s functions, so managing any irregularities with medication is paramount to your overall well-being. But if you’re taking one particular prescription drug for your thyroid, you could actually be compromising your health, according to a new nationwide recall. Keep reading to learn what medicine the FDA says to contact your doctor about, and for more pills that could be putting you at risk, check out If You Take This Popular Vitamin, Stop Immediately, FDA Warns. On Apr. 30, the FDA announced that Acella Pharmaceuticals, LLC, had voluntarily recalled a prescription thyroid medicine called NP Thyroid®, which is made of levothyroxine and liothyronine and is used for people with hypothyroidism. The company’s 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid® tablets have all been recalled. The medication was distributed nationwide to wholesalers, pharmacies, and healthcare offices. “The products subject to recall are packed in 100-count and 7-count bottles,” the notice says. The FDA announcement lists 35 100-count bottles, and three 7-count bottles among those recalled. You can check the full list on the FDA website. And for the latest health and safety news delivered straight to your inbox, sign up for our daily newsletter.ae0fcc31ae342fd3a1346ebb1f342fcb Routine testing found that the NP Thyroid® tablets contained less than 90 percent of the labeled amount of liothyronine (T3) and/or levothyroxine (T4)—which makes it less potent and therefore less effective. “Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid),” the notice posted on the FDA’s website warns. These include “fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.” And for another sign your thyroid may be out of whack, If You Notice This With Your Eyes, Get Your Thyroid Checked, Doctors Say. As of Apr. 30, 43 serious adverse events with a possible link to NP Thyroid® had been reported to Acella. “There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development,” the FDA notice explains. Additionally, elderly people and patients with underlying cardiac disease have an increased risk of “toxic cardiac manifestations of hyperthyroidism” when taking the recalled medicine, including cardiac arrhythmia, palpitations, and cardiac pain. And for more things to take out of your medicine cabinet, If You Have These Supplements at Home, the FDA Says “Destroy Them”. Acella is working to notify anyone they’ve shipped the medication to to stop distribution of the NP Thyroid® tablets in question. According to the notice, “patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.” Anyone with questions about the recall should email Acella Pharmaceuticals at [email protected] or call the company’s representatives at 1-888-424-4341. The FDA’s MedWatch Adverse Event Reporting program is collecting further reports on adverse reactions or other problems with the recalled drug. And for another reason to see your doctor, If You Can’t Stop Doing This at Night, Get Your Thyroid Checked.
