How it Works
Invokana, along with other medications such as Farxiga (dapagliflozin) and Jardiance (empagliflozin), are part of a class of drugs referred to as sodium-glucose cotransporter-2 (SGLT2) inhibitors. In a nutshell, the drugs help to remove excess sugar from diabetic patients by helping them pass it through urination. This helps to prevent a condition known as hyperglycemia, or high blood sugar levels.
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.
Unknown Invokana Side Effects 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.
Invokana Linked to an Increased Risk of Amputations
On May 16, 2017, the FDA announced that it is requiring the makers of Invokana to include a Boxed Warning, commonly referred to as a black box warning, because of an increased risk of foot and leg amputations. It did so based on the findings of two clinical trials.
Both trials, according to the FDA, showed that patients treated with Invokana were two times more likely to suffer either a leg or foot amputation than patients who only received a placebo. Researchers conducting the trials reported that the most common types of amputations were involved the middle of the foot as well as the toes. There were, however, amputations of the leg, both below and above the knee, reported as well. In some cases, according to the researchers, patients had to have both of their legs amputated.
As a result of these findings, the FDA recommends that patients using Invokana talk to their doctor immediately if they develop any of the following:
- Infections in their feet or legs
- Ulcers or sores
- Tenderness or pain
The FDA also recommends that healthcare professionals take a number of factors into account before prescribing Invokana. These include whether or not a patient suffers from diabetic foot ulcers, peripheral vascular disease or neuropathy. In addition, the FDA recommends that doctors also consider a patient’s history of a previous amputation when deciding whether or not to prescribe the drug.
The Institute for Safe Medication Practices reported that the FDA had received more than 450 reports of adverse medical events and complications from patients taking Invokana. These include:
- diabetic ketoacidosis
- increased risk of bone fracture
- kidney stones
- increased risk of fungal infections
- decrease in bone density
- kidney failure
- 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.
Legal Claims Against Invokana for Ketoacidosis & Lost Bone Density
Patients suffering from adverse side effects, complications, or diabetic ketoacidosis after taking the medication may be able to file a lawsuit against Invokana’s manufacturer, Janssen Pharmaceuticals or their parent company Johnson & Johnson. Potential claims may include:
- failure of Janssen Pharmaceuticals to properly warn of Invokana risks
- manufacturing a defective drug
- the risks and benefits of taking the drug Invokana were misrepresented.
Get Prequalified to File a Lawsuit Against Invokana Manufacturers
The national law firm of Baron & Budd may be able to help if you 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.
Get started online or call phone number to find out if you may be eligible to take legal action. Our attorneys represent clients in every state across the United States, and we have offices in Dallas, Los Angeles, San Diego, Austin, Baton Rouge, and New Orleans to better serve you.