Invokana Lawsuit: Diabetic Ketoacidosis

Basis of Invokana Lawsuit

The Invokana lawsuit is against the drug manufacturer for failure to warn about the risk of Invokana causing diabetic ketoacidosis (DKA). The Invokana lawsuits allege that Johnson & Johnson and their subsidiary Janssen Pharmaceuticals, Inc. failed to warn both prescribing doctors and patients of the potential risk of Invokana causing diabetic ketoacidosis. If identified and treated properly, diabetic ketoacidosis can usually be reversed quickly and easily. Unfortunately, most patients that have experience Invokana-induced diabetic ketoacidosis are not being properly diagnosed and treated. Failure to treat diabetic ketoacidosis in a timely fashion can result in extended hospitalization, organ damage, and even death. Our Invokana lawyers believe that if Johnson & Johnson would have provided adequate warnings on Invokana, then many physicians would not have prescribed Invokana, patients would not have consented to taking Invokana, and the signs and symptoms for Invokana-induced diabetic ketoacidosis would have been monitored closer. All Invokana lawsuits filed in Federal court have been consolidated into a Multi-District Litigation (MDL) in the United States District Court for the District of New Jersey under Judge Brian R. Martinotti. There Invokana lawsuits consolidated in New Jersey state court, where Johnson & Johnson is located. Invokana remains on the market in the United States, even as the lawsuits continue to pile up.

About Invokana

Invokana, also known by its chemical name canagliflozin, came to the market in the United States in 2013. Invokana was approved by the United States Food and Drug Administration for the treatment of adults with Type 2 diabetes. Invokana was the first of a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors to be approved for use in the United States. Invokana is touted as an oral, once-daily medication to improve glycemic control. Johnson & Johnson claimed that clinical trials also showed that Invokana was effective at reducing body weight and systolic blood pressure. However, these clinical trials were apparently unable to detect that Invokana could induce diabetic ketoacidosis.

FDA Action Regarding Invokana

Warning: Invokana Increases the Risk of Diabetic Ketoacidosis

On May 15, 2015, the FDA issued a warning that Invokana could result in too much acid in the blood, a condition known as diabetic ketoacidosis. The acid that will accumulate in the blood of a patient taking Invokana are called ketones. The FDA warned patients to pay close attention for any signs of ketoacidosis and to seek immediate medical care if symptoms occur. The FDA decided it was necessary to warn patients that Invokana could cause diabetic ketoacidosis after 20 Invokana-induced diabetic ketoacidosis cases were reported. Most of the patients had only been taking Invokana for around 2 weeks. Signs and symptoms of Invokana-induced diabetic ketoacidosis include:

  • Difficulty breathing
  • Nausea
  • Vomiting
  • Abdominal Pain
  • Confusion
  • Unusual Fatigue or Sleepiness
  • Increased Thirst
  • Dehydration
  • Fruity Smelling Breath

Invokana DKA warning

Warning: Invokana Increases the Risk of Bone Fracture

After Invokana had been on the market for over 2 years, the FDA required a label change on Invokana on September 19, 2015. The FDA required the label warn that Invokana could increase the risk of bone fractures and decrease bone mineral density. The FDA noted that bone fractures could occur as early as 12 weeks after starting Invokana. The FDA also warned that Invokana had been linked to a decrease in bone mineral density at the hip and lower spine.

Invokana bone fracture label change

Warning: Invokana Increases the Risk of Acute Kidney Injury

On June 14, 2016, the FDA required Johnson & Johnson to add a stronger warning to the label of Invokana, warning about the risk of acute kidney injury. The FDA required the stronger warning because it had received over 100 adverse event reports regarding Invokana causing acute kidney injuries. The FDA advised that Invokana can cause a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury can include decreased urine or swelling in the legs or feet. The FDA then notified physicians that if an acute kidney injury occurs while taking Invokana, the physician should promptly discontinue the drug and treat the kidney impairment.

Invokana acute kidney injury

Warning: Invokana Increases the Risk of Amputation

On May 16, 2017, the FDA released a safety announcement to patients and health care professionals that Invokana increases the risk of leg and foot amputations. The FDA warning was the result of two large clinical trials that were conducted after Invokana was introduced into the market. The FDA advised patients to contact their health care professional as soon as possible if they experience any new pain, tenderness, sores, ulcers, or infection in the legs or feet. All diabetics have delayed healing, but those on Invokana experience even more complications and delay in wound healing. Clinical trials have revealed that Invokana doubles the risk of amputation in diabetic patients.

FDA warning that Invokana increases risk of amputation

Invokana Side Effects Explained

Invokana-Induced Diabetic Ketoacidosis (DKA)

DKA is typically only seen in type 1 diabetics. When the body has insufficient amounts of insulin, it will start to burn fat for energy. When fatty acids are converted into energy, ketones are produced. Ketones are acidic, and if too many build up in the blood stream, the blood will become more acidic. Diabetic ketoacidosis is the name for when ketones have built up enough to lower the blood’s Ph. If DKA goes untreated, the patient will fall into a diabetic coma. Unlike type 1 diabetics, type 2 diabetics produce sufficient insulin. Therefore, type 2 diabetics are not at risk of DKA like type 1 diabetics. Invokana is approved for the treatment of type 2 diabetes. Invokana prevents the body from properly getting rid of ketones, which puts the user at risk of ketoacidosis. Because no warning is given that Invokana can induce ketoacidosis, and because type 2 diabetics aren’t normally at risk for diabetic ketoacidosis, many healthcare providers are unable to properly diagnosis or treat a patient presenting with Invokana-induced diabetic ketoacidosis. If diagnosed timely, ketoacidosis is easily reversible with fluids. If not treated timely, keotacidosis can be fatal. The focus of the Invokana lawsuit is that the manufacturer did not warn that Invokana could induce ketoacidosis, which resulted in many patients receiving inadequate treatment.Acute Kidney Injury caused by Invokana

Invokana-Induced Kidney Failure

Acute kidney failure is a life-threatening medical condition in which the patient’s kidneys stop filtering waste from the bloodstream. As the kidneys filter the blood, they also regulate electrolytes, blood pressure and glucose levels. If the kidneys quit functioning properly, serious complications can rapidly develop, such as uncontrollable sweating, shortness of breath, confusion, lethargy, abnormal heart rhythms, coma, and death. If treated timely, kidney function can be restored. However, some patients will have impaired kidneys for the rest of their life. Numerous Invokana lawsuits allege that patients have required kidney transplants after experiencing Invokana-induced kidney failure.

Invokana-Induced Heart Attack

Heart attacks caused by Invokana are secondary to Invokana inducing diabetic ketoacidosis. As the body’s blood becomes more acidic, every organ is stressed. The patient soon becomes dehydrated due to excessive urination as the body unsuccessfully tries to get rid of the ketones. The kidneys become strained and start to shut down, causing blood electrolyte imbalances quickly appear. At this stage of DKA a patient can experience a heart attack. Our Invokana lawyers have identified several cases where a patient suffered a heart attack while on Invokana, but DKA was not properly diagnosed. Invokana lawsuits are complex, and having an attorney that understands the science underlying the Invokana lawsuits is important.

Dangerous SGLT2 Inhibitors Similar to Invokana

Johnson & Johnson has developed numerous SGLT2 inhibitors that are very similar to Invokana. Another common diabetic medication that utilizes the same active ingredient as Invokana is called Invokamet. Both of these drugs share the same active ingredient, canagliflozin. Invokamet also adds Metformin to the Invokana in a single pill. Below is a list of other SGLT2 inhibitors that are being investigated for potentially fatal side effects.

  • Jardiance
  • Xigduo XR
  • Glyxambi
  • Farxiga

Scientific Articles on Invokana

Aug 2017: Ketoacidosis with Canagliflozin Prescribed for Phosphoinositide 3-Kinase Inhibitor-Induced Hyperglycemia: A Case Report.

A case report of a 69-year-old female who experienced ketoacidosis requiring hospitalization within one week of starting Invokana.

Jun 2017: Euglycemic Diabetic Ketoacidosis with Prolonged Glucosuria Associated with the Sodium-Glucose Cotransporter-2 Canagliflozin.

A case study on a 50-year-old women with type 2 diabetes who developed diabetic ketoacidosis (DKA) aftering starting canagliflozin (Invokana). The authors opined that SGLT2 inhibitors such as Invokana “may predispose patients not only to diabetic ketoacidosis but also prolonged glucosuria.” The studies authors also noted that “the US Food and Drug Administration issued a safety warning pertaining to the development of diabetic ketoacidosis (DKA) withthe use of SGLT2 inhibitors. DKA associated with SGLT2 inhibitors frequently develops in teh absence of hyperglycemia, which makes the diagnosis more challenging.”

May 2017: SGLT2 Inhibitor and Diabetic Ketoacidosis: Data From the FDA Adverse Event Reporting System.

The authors note that the US Food and Drug Administration Adverse Event Reporting System (FAERS) contains over 2,500 adverse event reports of suspected SGLT2i-induced diabetic ketoacidosis. 37 patients died from diabetic ketoacidosis while on a SGLT2i, such as Invokana.

Apr 2017: Euglycemic Ketosis in Patients with Type 2 Diabetes on SGLT2-Inhibitor Therapy- An Emerging Problem and Solutions Offered by Diabetes Technology.

The authors explain that drugs like Invokana “increase the risk of ketosis by increasing glucagon secretion in the pancreas and decreasing the renal excretion of 3-hydroxybutyrate and acetoacetate. When used in addition to insulin, any insulin dose reduction required to avoid hypoglycemia may lead to insufficient suppression of lipolysis and ketogenesis, sodium-glucose cotransporter2 inhibitor-induced loss of urinary glucose encourages euglycemia. Normo-glycemic or near-normoglycemic diabetic ketoacidosis represents a major threat to the health and well-being of a patient, because it may occur undetected and without any indicative hyperglycemia. In consequence, patients on [Invokana] are recommended to perform regular blood ketone tests since they are not alerted to incipient diabetic ketoacidosis by glucose testing alone.”

Mar 2017: Diabetic Ketoacidosis with Mild Hyperglycemia Associated with the Use of Canagliflozin. Report of One Case with Type 1 Diabetes.

A case report on a 20 year old female with hypothyroidism and type 1 diabetes, who developed vomiting and abdominal pain 2 months after starting canagliflozin (Invokana). The patient’s blood pH was 7.1 (metabolic acidosis). The authors warn that “diabetic ketoacidosis with mild hyperglycemia is a major complications of sodium-glucose cotransporter 2 inhibitors.” (Invokana is a sodium-glucose cotransporter 2 inhibitor).

Feb 2017: SGLT2 Inhibitors: A Systematic Review of Diabetic Ketoacidosis and Related Risk Factors in the Primary Literature.

A review of literature identified 34 case reports of SGLT2i-induced diabetic ketoacidosis. Symptoms included nausea, vomiting and abdominal pain. Invokana is a SGLT2i.

Jan 2017: Bone Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, in Patients with Type 2 Diabetes Mellitus

The study found that bone “fractures tended to occur as early as 12 weeks after initiating treatment and were primarily located in the distal parts of the upper and lower extremities. The reason for increased fracture risk with [Invokana] treatment is unknown…”

Aug 2016: Canagliflozin-Induced Diabetic Ketoacidosis: Case Report and Review of the Literature.

A case study of a 62-year-old women with type 2 diabetes and sudden-onset of diabetic ketoacidosis (DKA), due to canagliflozin (Invokana). She spent 5 days in the intensive care unit. The authors note that at the time only 73 cases had been reported in the FDA’s adverse event reporting system.

Jun 2016: Euglycemic Diabetic Ketoacidosis in a 27 Year-Old Female Patient with Type-1 Diabetes Treated with Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitor Canagliflozin.

A 27-year-old female with type 1 diabetes presented in diabetic ketoacidosis (DKA) after starting Invokana. The patient’s Invokana was discontinued and she did not go back into DKA.

Apr 2016: Diabetic Ketoacidosis with Canagliflozin, a Sodium-Glucose Cotransporter 2 Inhibitor, in Patients with Type 1 Diabetes.

Invokana was associated with an increased incidence of serious adverse events of DKA in patients with type 1 diabetes inadequately controlled on insulin.

Mar 2016: Severe Ketoacidosis Associated with Canagliflozin (Invokana): A Safety Concern.

The authors note that even though Invokana is not yet approved by the FDA to treat type 1 diabetes, the use of Invokana has been justified “by the fact that its mechanism of action is independent of insulin secretion or action. However, some serious side effects, including severe anion gap metabolic acidosis and euglyemic diabetic ketoacidosis (DKA), have been reported. Prompt identification of the causal association and initiation of appropriate therapy should be instituted for this life threatening condition.”

Jan 2016: Effects of Canagliflozin on Fracture Risk in Patients with Type 2 Diabetes Mellitus.

The study found that “overall, the incidence of fracture [adverse events] was higher with [Invokana] vs [Non-Invokana] in the broad population of patients with [type 2 diabetes] exposed to longer-term treatment.” Additionally, the fracture rate was noted to increase within the first few weeks of Invokana treatment and continued to increase the longer Invokana was used.”

Aug 2015: SGLT2 Inhibitors May Predispose to Ketoacidosis.

The authors of the study conclude that based on the physiology and pharmacology of SGLT2 inhibitors, such as Invokana, “there are several biologically plausible mechanisms whereby this class of drugs has the potential to increase the risk of developing diabetic ketoacidosis.”

Jun 2015: Euglycemic Diabetic Ketoacidosis: A Potential Complication of Treatment with Sodium-Glucose Cotransporter 2 Inhibition.

The authors sought to describe the association between SGLT-2 inhibitors (Invokana) and diabetic ketoacidosis in “hopes that it will enhance recognition of this potentially life-threatening complication.” The authors concluded that drugs such as Invokana “seem to be associated with euglycemic DKA and ketosis, perhaps as a consequence of their noninsulin-dependent glucose clearance, hyperglucagonemia, and volume depletion. Patients with type 1 or 2 diabetes who experience nausea, vomiting, or malaise or develop a metabolic acidosis in the setting of SGLT-2 inhibitor therapy should be promptly evaluated for the presence of urine and/or serum ketones. SGLT-2 inhibitors should only be used with great caution, extensive counseling, and close monitoring in the setting of type 1 diabetes.”

Invokana Lawsuit

Have you or a loved one suffered medical complications or injuries while taking Invokana? If so, you may be eligible for compensation. For a free Invokana lawsuit review, call the Hollis Law Firm today at 1-800-701-3672. Each Invokana lawsuit is reviewed on an individual case basis. The Hollis Law Firm represents clients nationwide on a contingent fee basis (no fee unless we win). To speak to a member of the Hollis Law team about your case, please contact the Hollis Law Firm by completing a contact form or by calling 1-800-701-3672.

Content Created By:

C. Brett Vaughn RN, BSN, JD

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