Invokana, the brand name for the drug canagliflozin, is a medication used by diabetics to help them manage their blood sugar levels. However, the drug has been associated with a condition known as diabetic ketoacidosis, which can sometimes result in potentially life-threatening complications. The national law firm of Baron & Budd may be able to help if you or someone you love has suffered adverse health effects after taking Invokana. Complete our contact form or call 866-912-8281 to learn more.
How it Works
Over time, the human body has evolved in a way that it is designed to conserve as much energy as possible. This worked fine for our ancestors, who were extremely active because they never knew where their next meal would come from. Most of us don’t have that problem today, but that often leads to the body storing far too much sugar, which, in turn, can result in the development of diabetes. SGLT2 prevents the loss of sugar – and this can be deadly for someone with the disease. As a result, Invokana was developed to inhibit the functions typically performed by SGLT2.
A Rousing Success
Since it gained U.S. Food and Drug Administration (FDA) approval in 2013, Invokana has been a major success for Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, which manufactures the drug. At the end of the first quarter of 2015, the drug had generated nearly $300 million in revenue. This is triple what it brought in for all of the previous year.
Invokana and the FDA
The FDA has carefully scrutinized Invokana since granting approval to the drug. In May 2015, the agency issued a Safety Communication warning healthcare providers and patients of a link between Invokana and the development of diabetic ketoacidosis. This is a very serious medical condition that increases the amount of acid in the blood to dangerously high levels. It occurs when ketones, or acidic waste products, are allowed to accumulate in the urine and the blood
Diabetic ketoacidosis develops when a patient’s body does not have a sufficient amount of insulin in order to ensure the proper level of glucose. As a result, the body begins to burn fatty acids as a reaction. This creates acidic ketone bodies, which trigger the condition. Symptoms include fatigue, abdominal pain, dehydration, confusion and vomiting.
According to the FDA, 20 patients reported having developed diabetic ketoacidosis after taking Invokana. They typically took the medication for about two weeks before symptoms began appearing. The FDA’s counterpart in Europe, the EMA, reported that SGLT2 medications caused more than 100 patients to develop the condition.
Then, in September 2015, the FDA announced that it was changing Invokana’s warning label to include an increased risk of bone fractures and loss of bone density. It cited a two-year study of more than 700 elderly patients in making its decision. According to the results of the study, patients who took the drug suffered a higher percentage of bone loss than those who participated but only took a placebo. The FDA also mentioned that Invokana users in the study were at an increased risk of fractures as soon as three months after beginning to take the drug.
Also, the Institute for Safe Medication Practices reported that the FDA had received more than 450 reports of adverse medical events from patients taking Invokana. These include kidney stones, kidney failure or impaired function, urinary tract infections and other issues.
How Baron & Budd Can Help
Serious questions have been raised as to whether or not the benefits of Invokana are worth the potential risks of taking the medication. In addition to the increased risk of diabetic ketoacidosis and bone fractures, drug trials conducted prior to approval of the drug showed that Invokana could also increase the risk of fungal infections.
Patients who have suffered health complications after the use of Invokana may be able to take legal action in order to obtain compensation. Potential claims may include a failure of the manufacturer to properly warn of the risks of taking the medication, negligence, and manufacturing a drug that was defective. In addition, a patient may be able to claim that the risks and benefits of taking the drug were misrepresented.
The national law firm of Baron & Budd may be able to help if your or someone close to you has suffered harm after using Invokana. We have a nearly four-decade track record of success representing our clients, and we may be able to put that experience to work for you. Complete our contactform or call 866-912-8281 to find out if you may be eligible to take legal action.