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New Diabetes Meds, Part 2: Understanding Side Effect Risks

new diabetes meds

There are a lot of new diabetes meds on the market right now, but how much do you really know? Today we’re comparing risks type 2 diabetics face with uncontrolled or undiagnosed symptoms versus known drug side effects — particularly Invokana. Uncontrolled type 2 diabetes causes many undesirable symptoms and disease-related health issues. Some simply lower your quality life, while others can be fatal if left untreated. To address these symptoms, many folks are eager to test out new diabetes meds like Invokana for controlling blood sugar.

Invokana’s active ingredient is canagliflozin, which falls under the SGLT2 inhibitor drug class. In type 2 diabetes, your body’s cells become resistant to insulin, which then leads to dangerously high blood sugar. Insulin is the main hormone responsible for controlling how much sugar exists in your bloodstream at any given time. Canagliflozin helps your kidneys release excess glucose from your blood through urine instead of absorbing it again to conserve energy.

Below, we’ll compare the risks involved with undiagnosed or uncontrolled type 2 diabetes symptoms vs. known Invokana side effect risks. Then, you can compare absolute and relative risks for taking Invokana to regulate blood sugar vs. no medication at all.

Side Effect Risks With New Diabetes Meds vs. Unmedicated Symptoms: Amputation (Lost Toes, Feet and Legs)

The absolute amputation risk for unmedicated type 2 diabetics is about 2%, at least in the United States. But taking Invokana more than doubles that risk for lost toes and feet cut off at or below the ankle. What’s more, diabetics account for 65% of all amputations each year.

As the FDA reports, an Invokana clinical trial (CANVAS) found that 5.9 in 1,000 patients lost a toe or foot. However, study participants given a placebo (i.e., the unmedicated symptoms group) reported 2.8 lower-limb amputations out of every 1,000 patients. In another CANVAS-R trial, the comparative risks were equivalent to 7.5 amputations per 1,000 patients taking Invokana or Invokamet XR. (Invokamet XR is the brand name for Invokana’s time-release formula, so they contain identical active ingredients.) However, the CANVAS-R unmedicated type 2 diabetes symptoms group reported 4.2 amputations per 1,000 clinical trial patients given a placebo.

Key Takeaway: Canagliflozin, which is Invokana and Invokamet’s active ingredient, more than doubles your risk for losing a toe, leg or foot. But luckily, lower-limb amputations don’t usually happen overnight. The best way to avoid unnecessary side effects from new diabetes meds is to ask your doctor about your options.

The FDA advises that your doctor consider these risk factors before prescribing Invokana or Invokamet to regulate your blood sugar:

  • Your personal amputation history, if applicable (i.e. toes, feet, fingers or other limbs cut off, usually due to severe infection)
  • Peripheral vascular disease (PVD)
  • Peripheral neuropathy (numbing or burning sensation in your feet that makes walking painful or even impossible)
  • Diabetic foot ulcers (this complication affects 10%-25% of type 2 diabetics and significantly increases your risk for losing a toe or foot)

Side Effect Risks With New Diabetes Meds vs. Unmedicated Symptoms: Kidney Problems

Uncontrolled diabetes symptoms can harm your blood vessels, including those in your kidneys. Kidney disease can happen once the ability to filter your blood stops working normally, and medications are often to blame. Kidney damage symptoms often include:

  • very dark urine
  • bloody urine
  • frothy urine
  • lower back pain
  • chronic kidney infections
  • urinary tract infections (UTIs)
  • swollen hands or feet

New diabetes meds like Invokana can help control blood sugar, which eliminates many kidney problems you’d have without taking medication. Unfortunately, there’s another side to this story: Invokana is also linked to increased risk for renal failure and kidney damage. In 2016, the FDA strengthened kidney injury warnings for certain new diabetes meds including Invokana, Invokamet, Farxiga and Xigduo XR.

According to the FDA, Invokana patients with acute kidney injury (AKI) symptoms and signs should seek medical attention immediately.

Between Invokana’s FDA approval in March 2013 and October 2015, the FDA received 101 confirmed AKI adverse event reports. Some patients needed hospitalization and dialysis; others were dehydrated, had low blood pressure or other health issues.

Key Takeaway: Before starting any new diabetes meds, ask your doctor to test your current kidney functionality level. This is a simple blood test and you’ll see the results listed as eGFR, which means “estimated glomular filtration rate.” If you don’t know what your eGFR should be, find the average measurement for your age below:

  • 116 eGFR for patients 20 to 29 years old
  • 107 eGFR for patients 30 to 39 years old
  • 99 eGFR for patients 40 to 49 years old
  • 93 eGFR for patients 50 to 59 years old
  • 85 eGFR for patients 60 to 69 years old
  • 75 eGFR for patients over 70

If your eGFR number drops dramatically after starting new diabetes meds, talk to your doctor.

Side Effect Risks With New Diabetes Meds vs. Unmedicated Symptoms: Unusual Breath

Many people with uncontrolled type 2 diabetes notice their breath smells a little odd — often describing it sweet or fruity. That’s because when your blood sugar levels are highest, your body starts breaking down fat for energy instead of carbohydrates. When this happens, it creates a chemical called acetone, which has a fruity smell others can detect on your breath. Unusual breath may indicate diabetic ketoacidosis, a condition which develops very quickly and can kill you if left untreated. Anytime you notice this symptom, seek emergency medical attention — even if you’re taking new diabetes meds besides Invokana or Invokamet.

While ketoacidosis is usually rare in type 2 diabetics, studies show new diabetes meds called SGLT2 inhibitors raise your risk.

Since June 2014, the U.S. Food and Drug Administration’s FAERS database shows Invokana patients reporting diabetic ketoacidosis hospitalizations and deaths. The agency is still investigating this safety issue to determine what warning or label changes to make for SGLT2 inhibitors.

Key Takeaway: Most type 1 diabetics know to test for ketones whenever their blood sugar gets too high. If you’re a type 2 diabetic worried about DKA, you can purchase ketone urinalysis test strips to use at home. Not sure where to look for these? You can order ketone strips from Amazon for $8 with Prime-eligible shipping here. If your test shows high ketone levels in your urine, don’t take any chances! Call your doctor’s office and explain your DKA symptoms and test results. If the number’s unusually high, you’re better off heading to the nearest emergency room or urgent care clinic for treatment.

How Injured Diabetics Can Qualify for Compensation

If you or someone you love had a toe removed while taking Invokana, you may qualify for a cash settlement. To check your eligibility for compensation, complete your free Invokana claim evaluation today. Once you submit your information, an experienced lawyer will call to discuss next steps for getting the justice and compensation you deserve.

For Part 1 in our series, read: New Diabetes Medications, Part 1: An In-Depth Comparison and Review.

Come back tomorrow to read our third installment in this series, New Diabetes Meds, Part 3: Invokana Lawsuits Reveal Hidden Dangers.

Related: Diabetic Ketoacidosis: The Invokana DKA Side Effect