According to a warning issued by the FDA in May 2015, the “The U.S. Food and Drug Administration (FDA) is 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.” Canaglifozin is one of the active ingredients in Invokana.
The FDA Adverse Event Reporting System (FAERS) identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. All 20 patients acquiring ketoacidosis that were reported to the FDA required emergency room visits or hospitalization to treat the condition.
The FDA has since indicated that it has continued to receive similar reports of patients with type 2 diabetes who were taking drugs like Invokana and developed DKA, and urged physicians and patients to report future incidents to the FDA MedWatch program. Other serious incidents of acute kidney failure and complications have also been reported.
The Invokana injury lawyers at Childers, Schlueter & Smith continue to get calls from patients suffering from alleged Invokana injuries such as: acute renal (kidney) failure and Ketoacidosis. Many of our clients have been hospitalized or spent time in the intensive care unit (ICU) given the severity of their event(s).
Invokana and DKA
DKA is a type of acidosis that most commonly occurs in patients with type 1 diabetes and is usually accompanied by high blood sugar levels, not in those with type 2 diabetes with only slightly elevated levels, making the FAERS cases atypical, and experts are unsure as to what is causing DKA in some patients who take Invokana.
DKA is rare in diabetes patients, but is potentially fatal. Its most common cause is the omission of insulin, but other causes include:
- Heart attacks
- Stomach bleeding
- Cushing’s syndrome
- Recent surgical procedures
- Medications including diuretics, beta-blockers, corticosteroids, antipsychotics, and anticonvulsants that affect carbohydrate metabolism and can result in DKA
Researchers have recently started to recognize that patients with type 2 diabetes can also contract DKA, and early symptoms include:
- Difficulty breathing
- Nausea and vomiting
- Abdominal pain
- Unusual fatigue
- Dry or flushed skin
- Excessive thirst
- Dry mouth
- A fruity odor on the breath
- Frequent urination
- High blood sugar levels
- High levels of ketones in the urine
Invokana is part of a class of drugs known as SGLT2 inhibitors that work to reduce blood glucose levels by promoting its incretion in urine, acting on the kidneys to block the reabsorption of glucose. The U.S. Food and Drug Administration (FDA) approved Invokana in 2013 for use along with diet and exercise to lower blood sugar in adults with type 2 diabetes. According to the FDA: “We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.”
If you have questions about Invokana and your legal rights contact our Invokana Injury Lawyers at Childers, Schlueter & Smith. Also check out our previous blog: Top 10 Things Invokana Patients Need To Know
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Table 1. List of SGLT2 inhibitors
|Brand name||Active ingredient(s)|
|Invokamet||canagliflozin and metformin|
|Xigduo XR||dapagliflozin and metformin extended-release|
|Glyxambi||empagliflozin and linagliptin|
A partner with Childers, Schlueter & Smith, LLC,, Brandon Smith has devoted his practice to pharmaceutical litigation, mass torts, products liability and serious personal injury. A frequent guest speaker at legal seminars all over the country—Brandon is focused on helping injured victims nationwide, however possible. Named a SuperLawyer in 2017, he has also been called out as one of 10 Best Attorneys For Georgia by the American Institute Of Personal Injury Attorneys.