Recall of Metformin Hydrochloride ER Tablets

Amneal Pharmaceuticals LLC Bridgewater is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Consumer Level. They were alerted by the U.S. FDA when testing seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, it showed Nitrosodimethylamine (NDMA) amounts above acceptable consumer FDA levels. Out of caution Amneal agreed to recall all seven lots and has not reported any adverse events directly related to the recall.

*Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.

Why is it being recalled?

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.

What products are being recalled?

Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are 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

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

June: National Migraine and Headache Awareness Month

For the month of June the goal is to raise awareness, address the stigma and build a stronger community of advocates. Migraine disease is one of the 20 most disabling medical illnesses in the world and the 12th most disabling disorder in the United States. More than 90% of migraine suffers can’t function normally during an attack.1 Migraine is an extraordinarily prevalent neurological disease, affecting 39 million men, women and children in the U.S. and 1 billion worldwide.5

Migraine Basics

Migraine is a genetic neurological disease, characterized by episodes often called Migraine attacks. They are quite different from regular headaches which are non-migrainous. Migraine sufferers may have moderate or severe pain and usually can’t participate in normal activities because of the pain. Many people experience migraines lasting for at least four hours or may last for days. The diagnosis usually happens if people have a combination of symptoms and doctors have ruled out other disorders.2

Build a Support Network

Migraine is a disabling disease that no one should have to go through alone. It’s essential to build a support network of understanding people who can not only empathize with your experience but be a helping hand during episodes. While there are a multitude of online support groups, talking with your friends and family about your experience will help since they are an invaluable resource to help you get through migraine attacks.3

Unusual Symptoms Related to Migraines

Some symptoms below aren’t associated with ‘regular’ migraine or headache episodes. Understanding all types of symptoms per episode can help recognize an episode before, during, and after it happens if ‘regular’ symptoms aren’t present.

For more information regarding National Migraine and Headache Awareness Month 2020 click here.

Tria Health and Migraines

Tria Health’s Pharmacy Advocate Program offers one-on-one, private consultations with a Tria Health Pharmacist. Your pharmacist will work with you and your doctor(s) to ensure you’re getting the intended outcomes from your medications.

Have any questions?

Contact the Tria Health Help Desk: 1.888.799.8742

Sources:

  1. https://migraine.com/living-migraine/yes-migraine-is-a-disability/
  2. https://migraine.com/migraine-basics/
  3. https://americanmigrainefoundation.org/resource-library/why-you-need-migraine-support-network/
  4. https://migraine.com/blog/i-had-no-idea-that-was-a-symptom/?via=recommend-reading
  5. https://migraineresearchfoundation.org/about-migraine/migraine-facts/

Keeping Employees Safe from the Inside Out

Image by Adam Niescioruk on Unsplash

National Safety Month

June is National Safety Month and while you should always be safety conscious, we felt this was a great opportunity to highlight a lesser known safety topic – medication adherence! Whether you’re supporting your employees or managing your own health, medication adherence is a critical component.  

Medication Adherence is An Important Safety Factor in Managing Chronic Conditions

Every year there are more than 125,000 pre-mature deaths due to medication non-adherence in the U.S. Many people are non-adherent because they don’t remember to take their medication or they can’t afford their medication, so they don’t take their medication without realizing the health and safety risks that can occur. Encouraging better safety medication practices improves overall health and reduces total health care costs..

More than 145 million Americans suffer from chronic conditions. Most chronic conditions are managed through medications prescribed by doctors and many times patients don’t understand the importance of taking a medication as prescribed.  However, for some it can mean additional health problems when adherence is not followed.. The Centers for Disease Control and Prevention (CDC) estimated that non-adherence caused 30-50 percent of chronic disease treatment failures2 and those who stopped treatment were likely to experience more problems.

Tips for Medication Management:

  1. Take medication at the same time every day.
  1. Include your medication with a daily routine. (i.e brushing your teeth or getting ready for bed) Before choosing a mealtime for your routine, check if your medication should be taken on a full or empty stomach. Also, check if your medication should be taken in the AM or PM
  2. Keep a “medicine calendar” with your medication and note each time you take or miss a dose.
  3. Use a pill container. Some have sections for multiple doses at different times, such as morning, lunch, evening, and even weeks.
  4. When travelling, be certain to bring enough of your medication, plus a few days extra, in case your return is delayed. Always travel with medication in your carry on, incase of lost luggage and temperature regulations.

Have questions regarding your medication?

Tria Health’s Pharmacy Advocate Program offers one-on-one, private consultations with a Tria Health Pharmacist. Your pharmacist will work with you and your doctor(s) to ensure the intended outcomes from your medications are being received.

Call the Tria Help Desk with any questions at 1.888.799.8742

Sources

  1. https://www.pillsy.com/hubfs/4481181/Pillsy_May2018/images/articles/medication-adherence-infographic-pillsy.png
  2. https://www.fda.gov/drugs/special-features/why-you-need-take-your-medications-prescribed-or-instructed

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

Positivity During a Pandemic

It seems like every day we are inundated with COVID-19 information.  While important, it can be overwhelming and depressing.  For people with chronic conditions, it can be downright scary!  Managing chronic conditions is more important than ever. Tria Health’s pharmacists have been hard at work, providing care to patients with chronic conditions, helping them through these trying times. Here are some recent patient success stories.

Allergies or COVID-19? 

It can be difficult individuals to understand the differences between allergies, asthma or COVID-19 symptoms. Knowing how to distinguish the condition will help in expediting treatment. For help understanding the differences between symptoms, see this Respiratory Illness Chart.

Tria Triumph

A patient had allergies, high blood pressure, and was struggling with her asthma. She couldn’t afford her inhaler and was terrified to leave her house due to COVID-19. Tria Health assisted the patient with getting the medication cost reduced and coordinated with the patient’s doctor and pharmacy. Tria was able to get the medication sent directly to the patient, reducing her risk of exposure. Tria was there to answer all her questions and concerns and educate her on the difference between respiratory illnesses.

Social Distancing Reducing Visits

For some, going into the doctor’s office was the only way of receiving affordable medications through samples or trial packets. Due to COVID-19, some people haven’t been able to safely leave their homes or afford their medications.

Tria Triumph

A patient with heart failure could not afford one of their critical medications. He was going to the cardiologist office every 2-3 weeks to get samples. His Tria Health pharmacist was able to sign him up for a manufacturer coupon at an affordable copay. Tria Health also had the prescription sent to a pharmacy with a drive through pick up to allow for appropriate social distancing for this high-risk individual.

Getting Diagnosed with COVID-19

If you have a confirmed COVID-19 diagnosis, it is important to take proper precautions to protect yourself and those around you. To learn the steps to help prevent the spread of COVID-19 if you are sick, click here.

Tria Triumph

A patient called the Tria Health Help Desk with questions and wanting information regarding their recent diagnosis of COVID-19. Tria helped educate the patient with quarantine recommendations, along with encouragement to keep a temperature log. If the patient started having breathing issues, they were instructed to go to the emergency room and to call ahead before going. Simply talking to a Tria Health pharmacist and having them provide a detailed overview of next steps helped put the patient at ease.

New Habits

While it’s important to continue your current treatment regimen to effectively control your conditions, now might be a great opportunity to instill some healthy habits.

Tria Triumph

During a smoking consult, a patient was struggling with anxiety and feeling completely out of control with the pandemic. She was not seeing any progress with quitting and was starting to feel down on herself. Tria’s pharmacist worked with the patient to refocus her efforts and make a list of things holding her back. During a follow up consult, the patient had cleaned out her smoking area, found new healthy habits, and started organizing her day. In addition, the patient is wearing a mask more often, which was also keeping her from smoking. Due to the support from the Tria Health pharmacist, the patient now has a happy place to enjoy the sunshine and her daughter.

Image Source: CDC

Sources:

  1. https://community.aafa.org/blog/coronavirus-2019-ncov-flu-what-people-with-asthma-need-to-know
  2. https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/steps-when-sick.html