More FDA Safety Warnings for Popular Type-2 Diabetes Medication

The U. S. Food and Drug Administration (FDA) is warning type-2 diabetes patients that a widely used medication to help control their blood sugar levels may also negatively affect their kidney function.

The FDA is strengthening drug safety warning labels on type-2 diabetes drugs known as sodium-glucose cotransporter-2 inhibitors (SGLT2), sold under the brand names:

  • Invokana (canaglifozin)
  • Invokamet (canagliflozin)
  • Farxiga (dapagliflozin)
  • Xigduo XR (dapagliflozin)

The stronger warnings are about the increased risk of acute kidney injury and making recommendations about how to minimize risk. SGLT2 medications are prescribed to type-2 diabetes patients to help lower blood sugar. Additional risks from using SGLT2s include low blood pressure, a condition of too much acid in the blood called ketoacidosis, serious urinary tract infections, and yeast infections.

Symptoms of acute kidney injury may include decreased urine or swelling of feet or legs, and the FDA recommends you seek immediate medical attention if you experience any of these symptoms, but cautions patients not to stop taking their prescribed type-2 diabetes medications without first speaking with their healthcare provider.

Patients should tell their healthcare provider before starting an SGLT2 if they are taking medications like water pills, blood pressure medication, or non-steroidal anti-inflammatories (NSAIDs) such as aspirin, ibuprofen, or naproxen, which may enhance their risk. It’s also important to let your healthcare provider know as soon as possible if you are eating or drinking less due to illness or fasting, or if you are losing fluids from vomiting, diarrhea or exposure to excessive heat. All of these factors can increase the risk of kidney function injury when also using an SGLT2 medication.

In half the reported cases of acute kidney injury, symptoms began within one month of beginning the medication although most patients recovered full kidney function after stopping the medication.

Before prescribing an SGLT2, the FDA recommends healthcare providers evaluate patients carefully for their individual risk of acute kidney injury by testing kidney function, and continue to regularly monitor patients while they are taking the medication. Pre-disposing risk factors for acute kidney injury with the use of SGLT2 medications include:

  • Decreased blood volume
  • Chronic kidney insufficiency
  • Congestive heart failure
  • Use of certain medications including diuretics, NSAIDs, and blood pressure medications called ACE inhibitors and ARBs

This news comes just after the FDA issued a Safety Communication warning type-2 diabetes patients using canagliflozin medications of the increased risk of extremity amputation with long-term use, especially toe, foot and leg amputations. (See more at https://bubalolaw.wpengine.com/blog/2016/06/popular-diabetes-drugs-may-increase-risk-amputation/)

If you are a type-2 diabetes patient taking one of the aforementioned SGLT2 medications and have suffered from acute kidney injury or any other problem while taking SGLT2 medications, please report any side effects to the FDA through FDA MedWatch at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home or call the FDA at 1-800-332-1088. You can also download the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm and fax to 1-800-FDA-0178.