Invokana Drug Claims

The type 2 diabetes drug Invokana (canagliflozin) was approved for sale in the U.S. in March of 2013 by the FDA.  Invokana is the first of a new class of prescription drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors.  SGLT2 inhibitors lower blood sugar by inhibiting the kidneys from reabsorbing glucose, causing some of the glucose to be flushed away through a patient’s urine.

The SGLT2 drug class includes the diabetic medications in the table below.


Brand Name

Active ingredient(s)




canagliflozin and metformin



Xigduo XR

dapagliflozin and metformin extended-release




empagliflozin and linagliptin

Safety Concerns About Invokana

There are now numerous Adverse Event Reports associated SGLT2 inhibitors. The most serious complications which may be linked to these medications are:

  • Diabetic Ketoacidosis (DKA)
  • Heart Attacks / Myocardial Infarctions (MI)
  • Kidney Damage / Renal Failure

ISMP Expresses Concern Over Invokana Safety

The Institute for Safe Medication Practices (ISMP) reported in its QuarterWatch report for the second quarter of 2014 (released on 5/6/15) that the Invokana had been linked with 457 reports of serious adverse events and indicated, “This was a higher total than for 92% of the drugs we regularly monitor.”

The authors conclude: “The current data are also insufficient to address unanswered questions raised in the FDA reviews about whether long-term use might result in a steady decline in kidney function, increased risk of bone fractures, or more cardiovascular events. By contrast, we observe clear evidence of harm to some patients in terms of hypersensitivity reactions and an array of renal adverse effects.”

FDA Issues Safety Warning on May 15, 2015

On May 15, 2015, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.

The FDA said its Adverse Event Reporting System database identified 20 cases of acidosis reported as diabetic ketoacidosis, ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors between March 2013 to June 6, 2014. It said all the affected patients required emergency room visits or hospitalization to treat the condition.  Since June 2014, the agency said it had continued to receive additional adverse event reports of diabetic ketoacidosis and ketoacidosis in patients treated with SGLT2 inhibitors.

According to the FDA warning, patients are urged to pay close attention for any signs of ketoacidosis and to seek medical attention immediately if symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness occur.   Patients should not stop or change diabetes medicines without first talking to their doctor.  Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.

Tampa Invokana Attorneys

Alley, Clark & Greiwe continues to litigate a number of pharmaceutical drugs cases.  Each personal injury attorney at our law firm has extensive experience representing clients seriously injured due to defective medical devices and drug products.  If you or someone you love has used an SGLT2 diabetes drugs and suffered a heart attack, kidney damage, or ketoacidosis please contact an experienced Unsafe Drug Product attorney at Alley, Clark & Greiwe for a free consultation regarding your legal rights.

Helpful Consumer Information on Invokana

  • Click here to read the FDA Safety Communication from May of 2015.
  • Click here to read more facts about Invokana from the FDA.
  • Click here to read the ISMP report released on 5/6/15
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