Recall of Metformin Hydrochloride ER Tablets

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.

Metformin HCl Extended Release Tablets, USP, 500 mg

Metformin HCl Extended Release Tablets, USP, 750 mg

*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.

What’s next?

  • 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.

Sources:

  1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended#recall-announcement
  2. https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin
  3. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayshore-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended
  4. https://www.miamiherald.com/news/health-care/article245133825.html

Chronic Conditions and COVID-19: Going Beyond Handwashing

Webinar Information

Managing chronic conditions has always been critical in regards to improving employee health and reducing healthcare costs. With the emergence of the COVID-19 health crisis, it’s more important than ever as patients with chronic conditions have a higher risk of complications with COVID-19. With a multitude of telehealth resources available, discover how pharmacists can make a significant impact on patients with chronic conditions.

Speakers:
Jessica Lea, CEO, Pharm.D., EMBA, BCPP
Jason Grace, Director of Clinical Services, Pharm.D.
Austin Morgan, Pharm.D.
Date: April 23, 2020
Time: 11:00AM – 12:00PM CDT

Know your Pharmacist, Know your Medicine!

As American Pharmacists Month, October is a great time to remember why your pharmacist is a key player in the health care system and how they can help you.

Pharmacists are Medication Experts
Pharmacists are trained on a wide variety of different disease states, but our specialty focuses on the medications used to treat those disease states within your body. We understand how medications work and can identify medication interactions and problems, including those involving non-prescription medications.

Pharmacists = Very Accessible Health Care Providers
Pharmacists are often available when other health care providers are not, and most often do not require you to schedule an appointment to ask questions about your healthcare needs.

Pharmacists Provide Much More than Medication Dispensing
Aside from dispensing medications, pharmacists can provide excellent counselling services about all medications (including herbal supplements) and a variety of different health conditions. Pharmacists play a major role in monitoring or managing several chronic conditions, such as asthma, diabetes, high cholesterol, high blood pressure, weight loss, and tobacco use. In fact, it has been proven that patients have better overall health outcomes if a pharmacist is involved on their healthcare team.

Pharmacists Help Ensure Your Meds are Safe, Appropriate & Effective
Pharmacists can look at all of your prescription medications as a whole to determine if they are safe, appropriate and effective in managing your health conditions. Your Pharmacist may also be able to assess if you’re taking medications you no longer need, if you have therapy duplication, if you’re missing certain medication that is proven to help your specific conditions, or if you’re taking something that could potentially be harmful to your health. The pharmacist can also suggest alternative drug options to lessen side effects, or reduce your drug costs.

Pharmacists can provide guidance for managing your overall health and navigating today’s ever-changing health care system. Talk to your pharmacist today and see how they can help you! For information about Tria Health, visit www.triahealth.com.

Driving Patients to Take an Active Role in Their Health Care

Katherine Meiners
Katherine Meiners, Director of Marketing & Communications

Central Exchange kicked off its 6 part Health Care Catalyst Series last week featuring consumer strategies related to having a healthy business. The presentation was led by Brent Walker, Chief Marketing Officer of C2B Solutions. Walker spent 20 years working for Proctor & Gamble prior to starting C2B Solutions.

The presentation focused on the importance of understanding psychographic segmentation in the health care consumer. C2B Solutions conducted a study that included a sample of 4,878 patients who completed a survey with 384 questions/attributes.

The study identified 5 different patient profiles:

  1. Balance Seekers (18%) – This group is proactive and wellness-oriented. They are open to many ideas, sources of information and treatment options when it comes to their healthcare.
  2. Willful Endurers (27%) – The highest population, this group takes a “don’t fix it if it’s not broken” approach to their health.
  3. Priority Jugglers (18%) – These individuals are busy taking care of others and are motivated by family verses by self.
  4. Self-Achievers (24%) – Highly motivated, this group focuses on future plans and is the most proactive when it comes to their wellness. They are task oriented and prefer to be given measurable goals.
  5. Direction Takers (13%) – The smallest population, these individuals like direction from providers and take it.

The varying differences in the patient profiles emphasize the need to communicate important health care messages differently. Traditionally, clinicians have been taught to speak to every patient as “direction takers.” With an increased focus on patient outcomes, clinicians need to learn how to better communicate with patients so they take an active role in their health care based on the different profiles. The benefit of the one-on-one counseling provided by Tria Health is our clinicians get an understanding of who the patient is and what motivates their medication behavior.

Find out what kind of patient you are by visiting C2Bsolutions.com.

Written by Katherine Meiners, Director of Marketing & Communications at Tria Health

Do You Take an Aspirin a Day?

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 Update:
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.