Patients prescribed Invokana (canagliflozin) for Type 2 diabetes may be at an increased risk for severe side effects. In addition to raising levels of acid in the blood leading to Ketoacidosis, these drugs have been found by the FDA to put patients at a greater risk for foot and leg amputations. New Boxed Warnings are required on these medications because of the severity of the risk. Patients taking these drugs are nearly twice as likely to have an amputation as those treated with a placebo over a year’s time.

The FDA updates regarding the health risks of taking canagliflozin were issued on July 20, 2017. Data from two large clinical trials confirmed the increased risk which mainly results in amputation of the toe or middle of the foot. People adversely affected also may have had an amputation of the leg. Some had their leg removed below the knee while others required removal above the knee. In some cases there were multiple amputations including both limbs.

Manufactured by Janssen Pharmaceuticals, type II diabetes drug Invokana is a SGLT2 inhibitor that increases urinary excretion of glucose, thereby improving glycemic control and promoting weight loss. Since approval of the first-in-class drug in 2013, the new data suggests that these drugs increase the risk of diabetic ketoacidosis – a serious condition where the body produces too much acid in the blood that may result in hospitalization. According to the Journal of Clinical Endocrinology, based on the physiology of SGLT2 and pharmacology of SGLT2 inhibitors, there are several biologically plausible mechanisms whereby this class of drugs has potential to increase the risk of developing diabetic ketoacidosis. The FDA found that the onset of the acidosis may occur after a median of 2 weeks(range 1 to 175 days) after taking the drug, suggesting a likely cause and effect relationship with the drug. Direct effects of SGLT2 on acid-base metabolism in the kidney are also possible, resulting in a renal tubular acidosis, according to the Endocrinology Network.

FDA Warnings

May 2015: The FDA issued a warning that SGLT2 inhibitors may lead to ketoacidosis. The recent post-marketing monitoring of the FDA Adverse Event Reporting System (FAERS) has identified 20 cases of acidosis (either diabetic ketoacidosis (DKA), ketosis or ketoacidosis) between March 2013 and June 2014 in individuals who were taking SGLT2 inhibitors. It found that most of these patients had T2DM, raising a concern that this may be a serious adverse effect associated with the SGLT2 inhibitor itself.

The FDA warning concerns the following drugs:

• Invokana (canagliflozin, Janssen)
• Farxiga (dapagliflzin, Astra Zeneca)
• Jardiance (empagliflozin, Boehringer Ingelheim)

Other drugs in this class include:

• Invokamet – canagliflozin combined with metformin (Johnson & Johnson)
• Xigduo XR – dapagliflozin combined with metformin (AstraZeneca)
• Glyxambi – empagliflozin combined with linagliptin (Lilly/Boehringer)

Following the FDA warning and recent reports linking the drug to the condition, the American Association of Clinical Endocrinologists will conduct the AACE Scientific and Clinical Review of DKA and the Effects of SGLT2 Inhibitors that will include scientists and diabetes experts examining available data in October 2015.

Symptoms of Renal Toxicity

• Kidney failure
• Impaired renal (kidney) function
• Kidney stones
• Ketoacidosis
• Dehydration
• Urinary tract infection
• Hypersensitivity

Symptoms of Ketoacidosis

• Decreased alertness
• Deep or rapid breathing
• Dry skin and mouth
• Flushed face
• Frequent urination or thirst that lasts for a day or more
• Fruity-smelling breath
• Headache
• Muscle stiffness or aches
• Nausea and vomiting
• Stomach pain

Get emergency medical help if you have any signs of an allergic reaction to Invokana or symptoms of renal toxicity or ketoacidosis.

The Harman Law Firm is passionately representing clients across the country who have been injured by dangerous and defective drugs and medical devices. We are currently investigating and reviewing new Invokana injury reports and claims.

If you or someone you know is currently taking INVOKANA or has taken and developed ketoacidosis, contact us and tell us what happened to see how we can help. Call for an initial consultation at no cost to you at (404) 554-0777 or by a contacting our office.