Following a recent warning by the U.S. Food & Drug Administration (FDA) which suggested that type 2 diabetics who take Invokana (generic: canagliflozin) may face an increased risk of acid buildup in their blood, a new study has identified a similar risk in patients with type 1 diabetes.
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What’s the Problem?
April 14, 2016 – For the study, a research team led by Anne L. Peters, MD, of the Keck School of Medicine at the University of Southern California looked at data from 351 type 1 diabetes patients with baseline HbA1c 7% to 9%. Test subjects were on a stable insulin regimen of multiple daily insulin injections or continuous subcutaneous insulin infusion for a minimum of 8 weeks prior to screening.
Participants were randomly assigned to take Invokana 100 mg (n = 117) or 300 mg (n = 117) or a placebo once daily before their 1st meal of the day. The researchers aimed to determine the effect of Invokana as an add-on to insulin on glycemic control and weight, as well as the incidence of severe adverse events including diabetic ketoacidosis (also known as DKA, diabetic acidosis, metabolic ketoacidosis or ketoacidosis).
At week 18, the incidence of ketone-related events was 5.1% among those treated with Invokana 100 mg, 9.4% with the 300 mg dosage, and none in the placebo group. Most adverse events occurred after patients had taken the drugs for at least 1 month.
DKA injuries requiring hospitalization occurred in 4.3% of the Invokana 100 mg group and 6% of the 300 mg group. Of the 12 test subjects who developed ketoacidosis, the range of blood glucose levels at the time of hospitalization was 9.4 mmol/L to over 44.4 mmol/L; 5 participants had blood glucose concentrations
Patients who took the 100 mg dose of Invokana had a median time of 116 days to a serious ketosis event compared to a median of 32 days with the 300 mg. Coexisting factors were present in all test subjects who suffered an adverse event including: influenza; pneumonia; infusion-site infection; food poisoning; insulin pump failure/malfunction; noncompliance with insulin regimen, or decrease in food intake.
There was no difference in baseline characteristics between patients who suffered a ketone-related injury compared to those who were not injured that would appear to predict additional risk.
“People with type 1 diabetes who use an SGLT-2 inhibitor are at increased risk for DKA, which appears to be dose related,” Peters said. “If [canagliflozin is] used in this off-label fashion, patients should be fully educated as to this risk and willing to monitor ketones at times of illness or other stress, and only the lowest dose of the SGLT-2 inhibitor should be used.”
Do I Have an Invokana Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Invokana lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by Invokana, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.