Several reports have been filed with the FDA about the condition and recently, Janssen Pharmaceuticals, a division of Jonson & Johnson and the manufacturer of Invokana, conducted a study to determine if the link should be of concern to users.
It should come as no surprise their conclusion was that Invokana does not cause any higher incidence of diabetic ketoacidosis, but there are still many who are concerned about the safety of the drug.
Janssen’s study used data from nearly 17,600 patients who had participated in randomized Invokana studies. Researchers collected data concerning diabetic ketoacidosis events, as well as ketoacidosis, metabolic ketoacidosis, and acidosis in general, each of which raises blood acid to potentially dangerous levels.
The study showed a dozen Invokana users experienced ketoacidosis events, with a slightly higher number of events for those taking more potent doses. Researchers believe those 12 patients were also likely taking insulin and might have had other risk factors for ketoacidosis. Results from the study were published in the diabetes journal Diabetes Care.
As a result of the study, Janssen reported to the FDA it had no reason to believe Invokana users had a significant risk for developing ketoacidosis and the company planned to stand behind the effectiveness and safety of its product.
What is Diabetic Ketoacidosis?
Ketoacidosis occurs when ketones build up in the blood, causing the acidity of the blood to rise. Elevated ketone levels are often found when someone fasts or eats an extremely low carb diet. They are used by cells as energy as a replacement for glucose.
If too many ketones are present in the blood and cells cannot use them quickly enough, they build up and the body does what it must do to excrete them. This can lead to dehydration, tachycardia, and hypotension, all of which can lead to a health emergency and require hospitalization where the patient receives fluids, electrolytes, and insulin. Left untreated, ketoacidosis can cause a person to fall unconscious, slip into a coma, and die.
Diabetic ketoacidosis is common for people with type 1 diabetes, but it is rarely a problem for those with type 2.
Ketoacidosis can trigger a variety of symptoms, including:
- Abdominal pain
- Difficulty breathing
- Fatigue or feelings of sleepiness
Some doctors have recommended Invokana users utilize at-home urine tests to track their ketone levels. If they notice levels are increased they can seek medical attention before a medical emergency occurs.
So Should Invokana Users Be Worried about Ketoacidosis?
The Janssen-backed medical study came amidst FDA concerns about ketoacidosis in Invokana and other medications like it. Invokana is still new to the market and was the first of the SGLT2 inhibitor diabetes drugs to be approved. It works by changing normal kidney function, so excess sugar is released in a user’s urine. Since its release, the FDA has received more than 20 adverse reaction reports involving various SGLT2 drugs, all of which required trips to the emergency room or hospitalization.
Janssen and Johnson & Johnson are facing legal action from Invokana users who believe the companies were aware of the risk for developing ketoacidosis while using the drug, but failed to warn doctors and patients. Attorneys are investigating whether the companies were negligent by not providing a warning or if they failed to complete adequate testing on the drug before it became available to consumers. If there is evidence either of these are true, Invokana users that suffered medical complications related to diabetic ketoacidosis might be eligible for compensation from Janssen and Johnson & Johnson.
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