Metformin Hydrochloride Extended Release Tablets are being recalled for having more carcinogen NDMA than the FDA’s acceptable allowance. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables.1 With levels above admissible according to the FDA it is being recalled ensuring no adverse reactions arise during consumption. If any adverse reactions are experienced you can submit them online here or find more information on how to mail or fax here. Many different retailers might be involved so it is important to check your label and bottle.
What products are being recalled?
Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are being recalled. They are the prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.1
The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.
*Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.1
Metformin HCI Extended Release Tablets manufactured by Bayshore Pharmaceuticals, LLC are also being recalled.
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg lots subject to the recall are identified in the table below.
Because Metformin is used to treat serious medical conditions, patients taking the recalled Metformin should continue taking their medicine until they have a replacement product.
To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another product not affected by this recall or an alternative treatment option.
There are currently over 30.3 million adults with diabetes, 23.1 million are diagnosed, and 7.2 million are undiagnosed. Every year over 1.5 million Americans are diagnosed.1 American Diabetes Month’s goal is to bring awareness about diabetes risk factors and encourage people to make healthy changes.
How can you help?
Encourage friends and family members to take the type 2 diabetes risk assessment
Promote healthy diet and lifestyle habits
Share information about diabetes on social media to increase awareness
Unfortunately, there are some risk factors you can’t change, like age, race, gender & family history. But being aware of your risk factors can help you take smart steps to improve your health in other ways.
Tria Health & Diabetes Management
If you currently are diagnosed or have been recently diagnosed with diabetes, Tria Health can assist you in managing your medications and finding a treatment plan that works for you. For employers that offer Tria Health’s Diabetes Management Program, Tria provides free diabetes testing supplies including a blood glucose meter, testing strips, and a mobile app designed to help you manage your diabetes better.
On May 2nd, The Food and Drug Administration (FDA) released a report regarding the use of daily aspirin to prevent a heart attack and stroke. The FDA’s findings may drastically alter how the health care industry utilizes daily aspirin therapy.
Background: A number of patients take a daily aspirin due to the belief that it reduces their risk of having a heart attack or stroke.
“Primary Prevention” – Refers to patients with diabetes, family history of heart disease, high blood pressure and high cholesterol who have an increased risk of heart attacks and stroke and use aspirin as prevention (before either of these events occur).
“Secondary Prevention” – Refers to the use of daily aspirin therapy for patients who have had a heart attack, stroke, or having known coronary artery disease. Secondary prevention use of aspirin has well established benefits and significantly reduces the chance of a second heart attack or stroke.
The FDA has reviewed new data regarding aspirin use for primary prevention and concluded that there is insufficient evidence at this time to support routine use of daily aspirin therapy in these patients.
What does this mean for you?
If you have not had a heart attack, stroke, or have known coronary heart disease and you take a daily aspirin, talk to your physician about the need for continued use of aspirin and weigh the risk versus benefit of prolonged aspirin therapy.
Monitoring blood sugar levels is an essential part of diabetes care. This provides the information needed to make adjustments to diet, exercise and medications. Waiting until symptoms of low or high blood sugar levels develop is a recipe for disaster.
Many things can cause blood sugar levels to change, such as: diet, exercise, stress, illness, drugs, and simply the time of day. Foods high in carbohydrates, emotional stress, infections, other medications, and early morning hours can cause blood sugar levels to rise. On the other hand, exercising can cause blood sugar levels to decrease.
Blood sugar levels can be measured easily at home or anywhere. Most blood sugar monitoring devices use a drop of blood obtained by pricking the tip of the finger with a small lancet. Most people find the pricking nearly painless. The machines are smaller than a deck of cards.
It is a good idea to keep a record of your blood sugar levels and report them to your doctor or nurse for dose adjustments of your medicines if necessary. Many people can learn to adjust the insulin dose on their own as necessary.
A1C is a test that doctors use to measure your average blood sugar control for the past 2-3 months. Your goal should be an A1C of less than 7%. Have your doctor check your A1C at least twice a year, or more frequently if your blood sugar is not well controlled.
Blood Glucose Monitoring:
Checking your blood sugars will let you know how well your diet and medications are working. It is normal for your blood sugars to rise and fall throughout the day, so it is important to talk with your doctor about when to check your blood sugars. Blood Glucose Targets: Fasting or before meals – 70-130 mg/dl; two hours after the start of a meal or snack – less than 180 mg/dl.
The combination of high blood pressure and diabetes can put you at higher risks for heart disease, kidney disease and stroke. Remember to take your blood pressure pills daily. Try to keep your blood pressure lower than 130/80 mmHg.
Keeping your cholesterol in check can help lower your risks of heart disease and stroke. Have your doctor check your cholesterol routinely. For more accurate cholesterol test results, avoid eating for 8 hours before you have your blood drawn.
Quitting smoking greatly decreases your risk of heart attacks, strokes, and other health problems. Talk to your doctor or pharmacist about the products available to help you quit smoking. Over the counter medications include nicotine chewing gum, lozenges or patches. Prescription options include: Buproprion SR (Zyban®), Varenicline (Chantix®), and nicotine inhaler or nasal spray.
Daily Foot Exams:
Check your feet daily for cuts, infections, sores, and make sure toenails are trimmed and kept clean routinely. If you notice any cuts, discolored skin, rashes, or sores that do not go away after 3-5 days, please notify your doctor.
Simple changes like these can help you live a healthier life with diabetes – Exercising 30-45 minutes three to four times a week; limiting alcohol intake to 1-2 drinks per day; reading the nutritional labels on food products to help monitor your intake of sodium and fat.
When your blood sugar is too low, you may experience dizziness, sweating, trembling, fast heartbeat, and wet clammy fingers. Treat these symptoms of hypoglycemia with the “Rule of 15’s.”
Eat 15 grams of carbs (i.e. ½ cup orange juice or non-diet soda, 1 tablespoon honey, syrup or sugar, 6 to 10 lifesavers, 1 glass of milk)
Wait 15 minutes, then recheck your blood sugar
If you’re blood sugar is still low, eat another 15 grams of carbs and repeat step #2
If your blood sugar is still low after repeating steps 1 through 3 twice, call your doctor or 911
Regular Check-ups & Immunizations:
Comprehensive dilated eye exam annually
Dental exams every 6 months
Monofilament foot exam yearly to check for nerve damage or diabetic neuropathy
Flu shots yearly
Pneumonia vaccine once if less than 65 years old; Repeat vaccine if greater than 64 years old and if first vaccine was given more than 5 years ago
Medications play an important role in your health and they work best when they are taken correctly. If you don’t take your medications as recommended by your doctor or pharmacist, they will not work as well as they should. It is important to follow the directions for each medication so you’ll get the most from them and stay in better health.
Visit Triahealth.com or call our Tria Help Desk at 1.888.799.TRIA (8742) for more information.