In the short time Invokana (Canagliflozin) has been on the market, FDA officials have issued at least 5 reports or warnings linking it to dangerous and potentially fatal side effects.
These include risks for:
In addition, the packaging insert warns of several other potential Invokana side effects, such as:
Depending on the severity of your side effects and when you took Invokana, you may qualify for compensation due to the failure of the manufacturer to properly warn of the risks.
Invokana, also known by its chemical name Canagliflozin, is prescribed to lower glucose (blood sugar) levels in adults with type 2 diabetes. Type 2 diabetes is a high blood sugar disorder that can cause severe side effects like heart disease, blindness, kidney disease, stroke, hypertension and nerve damage if not treated correctly. It is the 7th leading cause of death in the United States.
Canagliflozin was originally created by the Japanese pharmaceutical company Mitsubishi Tanabe Pharma, and approved by the U.S. Food and Drug Administration on March 29, 2013. However, it is currently marketed and sold by the Johnson & Johnson subsidiary Janssen Pharmaceutica.
Invokana is not intended to be used for the treatment of those with type 1 diabetes, those on dialysis or those suffering from ketoacidosis or kidney disease. It is also not intended for use by children with diabetes.
Invokana is the leading SGLT2 drug among competitors Farxiga and Jardiance, and ranks 7th in sales among all classes of diabetes medications. In 2016, Johnson & Johnson reported Invokana sales of more than $1.4 billion.
Invokana is a SGLT2 inhibitor drug of the gliflozin class. It works by blocking the 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.
Studies measuring how does Invokana work have also uncovered other effects, including lower blood pressure, reduced cardiovascular events and weight loss in some patients. Certain patients with type 1 diabetes have also reported lower blood sugar levels from Invokana.
As a result, some doctors have reportedly prescribed Invokana off-label (unapproved uses) for these purposes. Also, in October 2017, Johnson & Johnson requested that the FDA approve Invokana for reducing the risk of major cardiovascular injuries and death in those with diabetes.
Soon after approval of the drug in March 2013, the FDA began receiving a higher-than-expected number of reports linking Invokana and diabetic ketoacidosis.
Diabetic ketoacidosis, or DKA, results when a lack of insulin causes the body to use fat for energy rather than sugar. The by-product of this is ketones, which can build up to dangerous levels in the blood until they become toxic.
Invokana and diabetic ketoacidosis aren’t always related. DKA is the most common high blood sugar emergency and results in more than 150,000 hospitalizations each year. Most often, it affects those with type 1 diabetes.
However, DKA can strike in type 2 diabetes patients as the result of trauma, infection, surgery or drug interaction. In its advisory, the FDA stated every reported case of patients taking Invokana and suffering diabetic ketoacidosis resulted in hospitalization.
FDA reports have linked SGLT2 drugs like Invokana with Ketoacidosis. This occurs when the body doesn’t create enough insulin, which is needed to help glucose reach muscles and other tissues for energy.
Without the ability to use glucose for energy, 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.
In those with type 2 diabetes, interactions with drugs like Invokana may lead to ketoacidosis side effects, as can physical trauma or serious infections.
Some Invokana Ketoacidosis side effects may include:
In addition, new research out of Scotland presented at the 2015 meeting of the American Diabetes Association shows multiple episodes of diabetic ketoacidosis can triple the risk of early death.
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 Invokana ketoacidosis FDA warning was directed at endocrinologists and family doctors, and was titled “SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood.”
The warning advised “the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin (Invokana, Farxiga and Jardiance) may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.”
The agency also instructed doctors and patients to monitor for any symptoms of ketoacidosis such as:
Any patients noticing signs of ketoacidosis should seek immediate medical help. However, the FDA warned they should not stop taking their diabetes medication without first talking to their doctor.
While the Invokana ketoacidosis FDA warning was directed at all three SGLT2 drugs in the class, it was based primarily on reports of Invokana patients suffering higher rates of DKA and hospitalization between March 2013 and June 2014.
In the years since this warning, nearly 1,000 patients have come forward to file claims against J&J for ketoacidosis and similar injuries.
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.
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 June 14, 2016, the FDA posted a Drug Safety Communication in which it strengthened the warnings for the drugs Invokana and Farxiga, advising that they may increase the risk of kidney 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 addition to ketoacidosis and kidney damage, recent studies have uncovered certain Invokana side effects that may increase the risks of lower limb amputation.
On May 18, 2016 the FDA first warned of data from the ongoing CANVAS study that showed a troubling number of patients taking Invokana needing leg, foot or toe amputations.
This was confirmed in May of 2017, when the FDA added an official warning for Invokana, advising that it may increase the risk of leg and foot amputations.
Based on results of the CANVAS study released in June of 2017, the risk stemmed from higher occurrences of gangrene, ulcers, ischemia, infections and fractures, which can lead to loss of blood flow and tissue death.
With news spreading about the risks of amputation from Invokana, hundreds of victims have joined the nearly 1,000 lawsuits filed against Johnson & Johnson, leading a federal panel to create a special court to expedite the cases.
Since Invokana was approved for sale in 2013, the FDA has issued at least 5 public advisories about the potential dangers of the drug from kidney damage, ketoacidosis, pancreatitis, infections and limb amputation.
Reports have also linked it to bone fractures, joint pain, depression and hair loss.
However, the FDA has not issued an Invokana Recall at this time.
According to the FDA, Class I recalls are issued when there is a “reasonable probability” that using a drug or product will cause “serious adverse health consequences or death.”
Further, these recalls may be issued by the drug manufacturer itself, by the FDA, or by the manufacturer at the FDA’s request.
In the event of a recall, the manufacturer is instructed to stop shipping the product to distributors, and stores are instructed to remove the product from their shelves for return.
Although thousands of patients have reported severe side effects from Invokana, this represents only a fraction of the millions who have taken the drug. Therefore, there is little chance the FDA will order an Invokana recall.
Likewise, Johnson & Johnson is unlikely to order a recall of Invokana as the drug is currently one of their best-selling products, with nearly $1.5 billion in annual sales. Instead, it has been reported that the company is seeking to settle the growing number of lawsuits related to the drug.
In June of 2016, the FDA issued its quarterly Potential Signals of Serious Risks as identified by their Adverse Event Reporting System (AERS). Among the potential concerns were reports that patients had developed acute pancreatitis while taking SGLT2 inhibitors like Invokana.
At the time, the agency said it would evaluate the need for further action with regards to all SGLT2 drugs, including Invokana. At present, FDA records show nearly 275 reported cases of pancreatitis related to the drug. So far, however, no new warnings have been issued.
The reports included a June 29, 2015 case study published in Therapeutics and Clinical Risk Management, in which doctors cared for a 33 year-old woman hospitalized with pancreatitis only 2 weeks after starting Invokana.
Although the authors stated diabetes medications were rarely associated with acute pancreatitis, they stated the disease in this case was definitively caused by Invokana.
In August of 2015, doctors from the Mayo Clinic also posted a study of a patient presenting to the hospital with acute pancreatitis in what they called a rare occurrence, but directly related to Invokana use.
In this case, a 50 year-old male developed the disease after taking Invokana for only 4 days. The patient’s pancreatitis then worsened into ketoacidosis, requiring several days of aggressive treatment with IV fluids and insulin to stabilize.
Pancreatitis, which is the swelling or inflammation of the pancreas, may lead to serious injury, hospitalization or death if not treated quickly. Anyone taking Invokana is urged to monitor for signs of the disease, which can include nausea, vomiting, abdominal pain, weakness or vision loss.
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.
The results of this study, called CANVAS, were formally released in June of 2017, and showed that patients taking Invokana actually experienced a decrease in the number of cardiovascular outcomes or deaths.
Heart disease is currently the leading cause of death in America, with over 600,000 people affected each year.
Many patients taking Invokana have reported weight loss side effects, leading some to seek out the drug as an alternative form of diet therapy.
Ironically, Johnson & Johnson lists weight gain as a common side effect of Invokana. Conversely, the medication also lists “unexplained weight loss” as a side effect of unknown incidence.
At this time, it doesn’t appear as though J&J wishes to refute reports that their drug may also carry the unintended side effect of weight loss. In fact, the Frequently Asked Questions section of the official Invokana website contains a statement by the manufacturer to the following:
“Although INVOKANA® is not a weight-loss medicine, and each person is different, people can experience reduction in weight—on average 2–3%. Results may vary by dose and when used alone or with certain other diabetes medications.”
At the present time, there is no Invokana side effects warning for joint pain. However, this is a frequently-reported adverse reaction for this and other diabetes medications.
In September of 2015, the FDA added additional warnings to the label of Invokana for the potential risk of bone loss and bone fractures. Although the drug packaging already warned of such risks, the FDA decided stronger warnings were necessary after a study of 714 elderly patients found higher risks of bone loss with Invokana.
Despite this, nothing was added to warning labels of Invokana or other SGLT2 drugs for joint pain.
Currently, diabetes drugs in the DPP-4 class, such as Januvia, Onglyza and Nesina, contain a warning for joint pain. Experts say the SGLT2 class drugs have fought any attempts to add such warnings to their drugs for fear of losing market share to other classes.
Although hair loss is not one of the listed adverse reactions to Invokana, an increasing number of patients have reported partial or complete hair loss after beginning therapy with the drug.
Current FDA records show greater than 100 AERS reports filed for hair loss related to Invokana, and this may only be a fraction of the actual amount affected.
In most reported cases, patients experienced a regrowth of hair either while they continued taking Invokana or after they stopped treatment.
Due to the failure of Johnson & Johnson to properly warn of the Invokana side effects of hair loss, they could be liable for damages in severe cases where victims do not experience hair regrowth. However, there are no recorded lawsuits filed to date for this injury.
The official prescribing information for Invokana lists depression as a less-than-common side effect. However, recent FDA data shows nearly 170 AERS reports so far of patients developing depression or anxiety while taking the drug.
Invokana side effects of depression or anxiety have been reported by some patients as adverse reactions that appear when they begin treatment with the medication, and disappear upon stopping treatment.
If you experience depression while taking Invokana, it is not recommended that you stop taking it without first talking to your doctor.
The lawsuits are being filed on behalf of those patients who suffered:
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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