For more information of confidential assistance
201-342-5545
se habla español

FDA Cautions Diabetics about Invokana and Ketoacidosis

female patient with doctorIn conjunction with a healthy diet and exercise, diabetes treatments like Invokana have been shown to help lower blood sugar levels in patients with type 2 diabetes. This new class of diabetes drugs, known as SGLT2 inhibitors, is not without risks, cautions the FDA, which has received adverse event reports detailing high blood acid levels requiring patient hospitalization. Less than one month ago, health regulators issued a public safety communication on drugs including canagliflozin, dapagliflozin, and empagliflozin and a dangerous condition known as ketoacidosis. 

If you or a loved one has suffered harm or health complications after taking an SGLT2 inhibitor, you may have grounds for seeking legal compensation. National product liability lawyers at Eisbrouch Marsh are currently offering case evaluations for patients taking Invokana, Farxiga or Jardiance who believe the drugs’ side effects were not adequately warned about before they suffered health problems. A consultation with an Invokana injury lawyer is not only free of charge, but may shed light on liability issues that manufacturers will likely face.

Ketoacidosis risks and Invokana

According to the FDA warning, the agency’s (FAERS) database noted 20 cases of diabetic ketoacidosis in patients who were treated with SGLT2 inhibitors from March 2013 to June 6, 2014. All involved required hospitalization or emergency room visits to reverse the condition. If left untreated, ketoacidosis can cause a patient to lapse into a coma, and possibly die. Thus far, there have been no reports of death associated with Invokana or other SGLT2 inhibitors, though the FDA cautions patients to watch out for symptoms of high blood acid levels.

Ketoacidosis symptoms may include:

  • Abdominal pain
  • Unusual fatigue
  • Vomiting
  • Difficulty breathing
  • Nausea
  • Confusion

Canagliflozin, dapagliflozin, and empagliflozin are the active ingredients in diabetes drugs marketed under the brand names Farxiga, Jardiance and Invokana, as well as the combination drugs Invokamet, Glyxambi and Xigduo XR.

Diabetic patients who have suffered health complications as a result of their use of Invokana may argue that had they been aware of the risks posed by SGLT2 drugs, they would have chosen a safer, alternative treatment.

Janssen Pharmaceuticals releases study results

Only three days after the FDA safety communication, Invokana maker Janssen Pharmaceuticals issued a press release citing results from “three real-world analyses” suggesting that Invokana offered patients “significant improvements in blood glucose (A1C)” and “a statistically significant reduction in A1C levels from 8.3 percent to 7.6 percent.”

The manufacturer mentioned common side effects of Invokana, such as yeast infections, urinary tract infections and changes in urination, but made no mention of ketoacidosis risks.

Protect your legal rights

Winning dangerous drug lawsuits for more than 25 years, the attorneys of Eisbrouch Marsh offer skilled, compassionate legal advocacy for patients who have been harmed by prescription and OTC pharmaceuticals.  A successful claim, whether settled out of court or tried before a jury, can net plaintiffs substantial compensation for lost income, past and future medical expenses and pain and suffering.

To learn more about your options for legal recourse, or to schedule a consultation with an Invokana lawyer, please call our offices at 201-591-1624. We are here to answer your questions and protect your best interests.

  1. FDA, Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm
  2. PR Newswire, New Real-World Data Show Adults with Type 2 Diabetes, Including Those Taking Multiple Diabetes Medications, Achieve Blood Glucose Treatment Goals After Using INVOKANA® (canagliflozin) http://www.prnewswire.com/news-releases/new-real-world-data-show-adults-with-type-2-diabetes-including-those-taking-multiple-diabetes-medications-achieve-blood-glucose-treatment-goals-after-using-invokana-canagliflozin-300084699.html