A new study suggests that Invokana could be beneficial in treating Type 1 diabetes. However, there may be downsides to the approach, particularly the possibility that Invokana could be associated with diabetic ketoacidosis.
Invokana (canagliflozin) is an oral medication marketed by Johnson & Johnson’s Janssen Pharmaceuticals unit that is currently approved to treat Type 2 diabetes. The drug belongs to a class of treatments called SGLT2 inhibitors that lower blood glucose levels by facilitating removal of glucose via the kidneys. Brought to market in March 2013, Invokana was the first SGLT2 inhibitor approved for sale in the U.S.
In order to ascertain the safety and efficacy of Invokana in treating Type 1 diabetes, researchers from the VA San Diego Healthcare System and the University of California looked at data on 351 patients with the disorder who were receiving multiple daily injections of insulin or subcutaneous insulin infusion. One group of subjects received 100mg of Invokana; another received 300mg of Invokana; and a third were given a placebo. The effects were studied over an 18-week period.
According to a write-up of the study that was published last month in Diabetes Care, Invokana lowered HbA1c levels, body weight and insulin dosage, without increasing the incidence of hypoglycemia. However, those taking the 100 mg dose of Invokana had a 5.4% rate of ketone-related adverse events, including ketoacidosis. Those given the larger 300 mg dose had a 9.4% rate of such events. None of the patients in the placebo group experienced such an event.
Diabetic ketoacidosis occurs when toxic acids called ketones accumulate in the blood stream. This dangerous condition, which can lead to diabetic coma and death, is already a risk faced by people with Type 1 diabetes. It should be noted that Invokana and other SGLT2 inhibitors have not been proven safe and effective Type 1 diabetes, and none have been approved by the FDA for this indication.
In May, the FDA announced it was investigating at least 20 cases of diabetic ketoacidosis in patients who were taking SGLT2 inhibitors that had been reported to its adverse event database between March 2013 and June 6, 2014. While some of the cases involved Type 1 diabetics who were prescribed the drugs off-label, the majority involved Type 2 diabetes patients. The agency noted that this was atypical, as diabetic ketoacidosis generally presents in Type 1 diabetics.
The FDA has not determined that Invokana and other SGLT2 inhibitors cause ketoacidosis in Type 2 diabetics. The agency’s review will determine whether or not this potential side effect should be noted on the drugs’ labels. Patients using this class of medication should contact their healthcare provider at once if they experience difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, as these symptoms are typical in patients experiencing diabetic ketoacidosis.
If you or a loved one were hospitalized with diabetic ketoacidosis while using Invokana or another SGLT2 inhibitor to treat Type 2 diabetes, now is the time to seek legal advice. To learn more about filing an Invokana lawsuit, please call for a free review of your potential case.