Serious cases of diabetic ketoacidosis (too much acid in the blood) have been linked to Invokana and other diabetes drugs in the SGLT2 inhibitor class. The first lawsuits were filed in December 2015, shortly after the FDA ordered Janssen Pharmaceuticals to add a new warning label.
Need a Texas Invokana Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with diabetic ketoacidosis (DKA), you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
In December 2015, a man who developed ketoacidosis after taking Invokana filed a lawsuit (Case No. 15-12-00653) against Janssen Pharmaceuticals in the Philadelphia Court of Common Pleas. He accuses the drug-maker of negligence for selling a defective drug and failing to adequately warn about side effects.
Invokana and Ketoacidosis
Invokana (canagliflozin) belongs to a new class of diabetes drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors. It improves blood-sugar control by helping the kidneys remove excess glucose from the body in urine.
Unfortunately, Invokana has been linked to dozens of cases of diabetic ketoacidosis, a side effect that involves too much acid in the bloodstream. Without treatment, ketoacidosis can cause coma and death.
According to a study published in Diabetes Care, Invokana is associated with a higher risk of ketoacidosis than other SGLT2 inhibitors. Patients on higher doses of Invokana (300-mg) also have a higher risk than patients on lower doses (100-mg).
Are There Risk-Factors?
In some cases, just before or at the same time ketoacidosis occurred, patients experienced acute illness (such as, urinary tract infection, urosepsis, gastroenteritis, influenza, trauma or surgery), reduced caloric or fluid intake, and/or reduced insulin dose.
Symptoms of Ketoacidosis
- Abdominal pain
- Nausea, vomiting
- Excessive thirst
- Difficult breathing
- Unusual fatigue and sleepiness
What is Diabetic Ketoacidosis?
Diabetic ketoacidosis (DKA) is a serious medical condition that occurs when the body starts breaking down fat cells to use as fuel instead of using sugar (glucose) in the bloodstream. When fat cells break down, they release acids called ketones.
Invokana patients who experience these symptoms should immediately seek medical attention. If diabetic ketoacidosis is not diagnosed or treated early, it can lead to more serious symptoms like dehydration, deep gasping breathing, confusion, coma, and even death.
Normal Blood-Sugar Levels May Delay Diagnosis
Diabetic ketoacidosis usually occurs in patients with type-1 diabetes who have very high blood-sugar levels. However, for unknown reasons, it has also been reported in patients with type-2 diabetes on Invokana who had only moderately increased blood-sugar or normal levels. These uncharacteristic blood levels could delay diagnosis and treatment.
Safety Warnings for Invokana and Diabetic Ketoacidosis
May 15, 2015 — The FDA issued a Safety Communication after receiving 20 reports of diabetic ketoacidosis in patients with type-2 diabetes on SGLT2 inhibitors.
June 2015 — A warning was issued by the European Medicines Agency (EMA) after 101 reports of diabetic ketoacidosis were linked to SGLT2 inhibitors.
December 4, 2015 — The FDA issued a warning about ketoacidosis and updated the label on Invokana. From the March 2013 until May 2015, the FDA received 73 reports of ketoacidosis in patients on SGLT2 inhibitors. All of the patients were hospitalized or treated in an emergency department. It is likely that many more cases were never reported.
What Should I Do?
According to the FDA recommendation for patients on Invokana:
“Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.”
Need an Invokana Ketoacidosis Lawyer in Texas?
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