If you or a loved one has experienced debilitating side effects or injuries from a dangerous medication, then you might be entitled to compensation. Learn more about what to do if you have had serious health concerns stemming from the use of Invokana, the culprit behind severe injuries and serious health conditions and side effects.
A personal injury attorney from Ed Bernstein & Associates can evaluate your case to determine if you have grounds for a claim. We have represented those who have been injured by pharmaceuticals for over 40 years.
Call 702-996-3917 to schedule a free consultation with a Las Vegas injury lawyer.
What is Invokana?
Invokana is manufactured by Janssen Pharmaceuticals – a subsidiary of Johnson & Johnson. It is marketed as the only type 2 diabetes medication that lowers the risks of heart failure, end-stage kidney disease and worsening kidney function. It is a drug meant to be prescribed along with a healthy diet and exercise to lower blood sugar.
Both Ivokana and Invokamet XR are hailed as trailblazers in a completely new line of diabetes medications. SGLT-2 inhibitors or sodium-glucose co-transporter 2 inhibitors stop the kidney from reabsorbing glucose, directing it to the patient’s urine instead. This is an effective way of lowering blood sugar levels in type 2 diabetes patients and has not yet been approved for use in type 1 diabetes patients. SGLT-2 inhibitors include:
- Canagliflozin (Invokana)
- Dapagliflozin (Farxiga)
- Empagliflozin (Glyxambi)
These inhibitors are used as second-line or third-line agents, or as part of combined therapy, because of their limited time on the market and ongoing research. It is worth noting that this medication is not meant to be the sole treatment for type 2 diabetes.
FDA approval
Invokana, (generic name canagliflozin) was approved by the FDA in 2013 as medication for adults meant for type 2 diabetes, diabetic kidney disease, and cardiovascular risk reduction. This was considered to be an important milestone in the treatment of type 2 diabetes, because of the high associated risk for DKD (diabetic kidney disease) and diabetes-associated heart failure in diabetic patients. In fact, 1 in 3 diabetes type 2 patients in the US have these sorts of complications.
There are concerns that Invokana was released without sufficient testing and warnings. It was only three years after Invokana’s debut that the FDA issued a second warning about the drug, saying that the risk of lower limb amputation for those taking Invokana was near twice the risk of those not taking an SGLT-2 inhibitor. These warnings were not present on any packaging and were not communicated to doctors
FDA and ISMP warnings about Invokana
Only 2 years after it’s approval, the Institute for Safe Medication Practices (ISMP) raised concerns about whether there was enough research done on Invokana. They signaled that in the long run, the risks of this new drug might outweigh the benefits, and might actually damage the kidneys after prolonged use.
Invokana simply hasn’t been tested long enough to answer these questions. A 2014 study published in The Journal of Clinical Investigation states that later testing on another SGLT-2 inhibitor (dapagliflozin) revealed that while the drug improved muscle insulin sensitivity, it actually enhanced endogenous glucose production and increased levels of glucagon, the hormone responsible for raising blood sugar.
A year later, the FDA issued a Drug Safety Communication with regards to all lines of SGLT-2 inhibitors about the risk of high blood acid levels and serious UTIs (urinary tract infections) that required hospitalization. Warning labels were added to Invokana in 2015.
The FDA had a long list of cases in its Adverse Event Reporting System in the timespan of March 2013 to March 2015. Some of these include:
Ketoacidosis – this is often not diagnosed quickly enough in diabetic patients taking SGLT-2 inhibitors, because in many cases, the blood glucose level remains much lower than in other diabetic ketoacidosis cases, and the condition simply isn’t suspected. All patients require hospitalization and emergency treatment.
Sepsis – there were 19 cases of dangerous blood infections and kidney infections. They have started as UTIs and some patients suffered kidney failure as a result.
Urinary Tract Infections – there were serious UTIs reported that sometimes have led to hospitalization and further complications (like sepsis).
Known Invokana-related side effects, complications, and injuries
There are other side effects of Invokana – symptoms that have been reported and are considered very serious. They include:
- Heart disease
- Diabetic ketoacidosis
- Lower limb amputations
- Kidney damage and failure
- Acute pancreatitis
- Urinary tract infections (UTIs)
- Dehydration
- Vaginal yeast infection
- Yeast infection of the penis
One of the most recently discovered side effects of Invokana is Fournier’s gangrene that affects the genital region. Also known as necrotizing fasciitis of the genital region, it is attributed to the use of SGLT-2 inhibitors.
Note: If you have had amputations in the past, you are at more risk of having an amputation when taking Invokana or any other SGLT-2 inhibitor.
Diabetic ketoacidosis has different symptoms on Invokana
Diabetic ketoacidosis is one of the most severe diabetes complications. It happens when the body starts to break down fat for fuel – this process produces ketones. Ketones are acids that build up over time – this buildup leads to Ketoacidosis. This requires immediate attention, and the symptoms include:
- Fatigue
- Abdominal pain
- Nausea
- Vomiting
- Confusion
- High blood sugar level (This may be absent in the case of ketoacidosis caused by SGLT-2 inhibitors. )
- Increased LDL
- Heart attack
- Stroke
- Kidney stones
- Allergic reactions
- Genital gangrene
Note: High blood sugar may be absent in cases of diabetic ketoacidosis.
Invokana related lawsuits and settlements
Invokana patients who were injured after taking Invokana have filed as many as 1,200 lawsuits in both federal and state courts. The most common is the Invokana amputation lawsuit.
These lawsuits claim that Janssen Pharmaceuticals failed to provide proper warnings upon the release of this drug, based on the evidence that was already available to them at the time. the CANVAS and CANVAS-R clinical trials contain evidence that Janssen Pharmaceuticals could have warned people about risks much earlier. Both of the trial results can be viewed at ClinicalTrials.gov.
Lawsuits claim that Janssen Pharmaceuticals failed to warn patients about known side effects, and caused injury, pain, and suffering as a result.
Filing a lawsuit
Filing a lawsuit against a company like Johnson & Johnson and Janssen Pharmaceuticals can seem intimidating, but we can assist you. Come and see us in our Las Vegas office, and we will give you a free consultation with an expert who will look over your medical records and help you make sense of them.
Call 702-996-3917 to schedule a free consultation with our personal injury attorney.
Types of compensation granted
The compensations granted in Invokana lawsuits vary – nothing will replace the quality of life after a lost limb, but you may be entitled to compensation for:
- Medical bills
- Physical therapy
- Loss of wages
- Future expenses
- Travel costs
- Funeral expenses
- Pain and suffering
Although most patients file an Invokana amputation lawsuit, there are a lot of other injuries that resulted from the lack of proper warnings.
Evaluating your case with Ed Bernstein & Associates
We want to help you with your claim and believe that pharmaceutical companies have a moral and legal obligation to warn patients about any known side effects and health risks that their medications pose.
Janssen Pharmaceuticals has known about the risks – they were described in the clinical trials. We will help you determine if you can file an Invokana lawsuit.