Following a recent FDA warning of critical ketoacidosis dangers from the drugs Invokana and Invokamet, lawyers have initiated a national invokana lawsuit on behalf of those injured. Read more about the drug, its dangers and your rights below. If you have experienced ketoacidosis, call us to speak directly with a lawyer today.
Invokana, also known by its chemical name Canagliflozin, is a drug prescribed to lower glucose levels in adults with type 2 diabetes. It is a SGLT2 inhibitor drug of the gliflozin class.
The medication was created by Japanese pharmaceutical company Mitsubishi Tanabe Pharma, but is currently marketed and sold by the Johnson & Johnson subsidiary Janssen.
Invokana works by blocking the SGLT2, or subtype 2 sodium-glucose transport protein (SGLT2). This protein causes around 90% of the kidneys’ absorption of glucose. Without it, a substantial amount of sugar is expelled through the urine rather than being retained in the blood.
Other effects of this include a lowering of blood pressure and weight loss in some patients. Certain patients with type 1 diabetes have also reported lower blood sugar levels from Invokana, leading to off-label prescriptions for these purposes.
Invokana is only approved for type 2 diabetes. It was approved by the European Medicines Agency in 2011 and by the United States FDA in March of 2013. It sold over $500 million in 2014 and is on pace to break $1 billion in sales for 2015.
Type 2 diabetes has grown to the 7th leading cause of death in the United States. It can cause severe side effects like heart disease, blindness, kidney disease, stroke, hypertension and nerve damage if not treated correctly.
During clinical trials of invokana, it was noted that patients taking the drug had a higher rate of heart attack (myocardial infarction) or other cardiovascular event during the first 30 days of ingestion than those taking no drug at all. Invokana was also associated with a slightly higher risk of stroke.
In 2013, during an FDA panel discussion over the safety of invokana, several committee members voiced concern over the cardiovascular risks of the drug. However, it was ultimately approved for sale in the U.S. In exchange, Janssen was required to conduct additional studies into cardiovascular risks, which are expected to be released later in 2015.
A heart attack, or myocardial infarction, occurs when blood and oxygen are restricted from reaching the heart due to an arterial blockage. This causes permanent damage or death to heart tissues, which can be fatal.
Heart disease is currently the leading cause of death in America, with over 600,000 people affected each year.
In addition, the FDA and other health experts have raised questions about more serious side effects such as heart attacks and other cardiovascular events, kidney damage and ketoacidosis. Users are strongly cautioned to watch for symptoms of these complications.
Reports have also suggested that invokana may contribute to kidney damage. Prior to FDA approval, clinical trials on animals found that long-term use of the drug was related to permanent kidney damage.
In May of 2015, the Institute for Safe Medication Practices featured a report on Invokana, advising that a high number of patients using it in the year following its approval reported serious side effects.
Of the more than 450 adverse event reports filed with the FDA, over 10% were related to kidney failure or damage.
Kidneys perform the vital functions of removing waste from the blood and regulating red blood cell production, blood pressure and electrolyte balance.
Any damage to the kidneys can lead to a build-up of fluids and waste in the body. This can cause heart and lung problems, weakness, mental impairment or even death.
In June 2015, due to lingering questions about the risks of invokana, Janssen initiated a new study to measure its effects on the liver and kidneys.
On May 15, 2015, the FDA issued a warning that the SGLT2 diabetes drugs Invokana, Farxiga and Jardiance may increase the risks of ketoacidosis.
The report stated: “The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.”
The agency continued: “Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.”
Ketoacidosis occurs when the body doesn’t create enough insulin, which is needed to help glucose reach muscles and other tissues for energy. When this happens, the body must burn fat to gain energy, which can lead to high levels of toxic acids, or ketones, in the bloodstream. Without proper treatment, this may worsen to ketoacidosis.
According to new research by Scottish scientists presented at the 2015 meeting of the American Diabetes Association, multiple episodes of diabetic ketoacidosis can triple the risk of early death.
Symptoms of ketoacidosis include:
The FDA has warned that patients should not stop taking invokana without first talking to their doctor. However, if you have been diagnosed or treated for ketoacidosis after taking Invokana, Farxiga or Jardiance, you may qualify for compensation from a new lawsuit.
Lawyers have started a national lawsuit against the makers of several SGLT2 diabetes medications for those who suffered serious side effects.
The drugs included in the lawsuit are:
If you have taken any of these drugs, you may be entitled to financial compensation.
The suit claims that the drug makers failed to properly warn patients and doctors of the most severe side effects of these drugs, causing additional injuries.
Lawyers expect that thousands of patients will ultimately come forward with injuries to file claims. As is often the case with drug injury lawsuits, cases may eventually be consolidated in a central federal court for expedited handling.
A lawyer can speak with you today to determine if your case qualifies, and it costs nothing to investigate or file your claim unless you receive compensation. Contact DrugNews to speak directly with a lawyer involved with these cases.
Speak with a lawyer who specializes in the diabetes medication litigation.
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