Patients who took the type 2 diabetes drug Invokana (canagliflozin), Invokamet (canagliflozin/metformin) or other similar drugs like Jardiance, and then suffered serious side effects like kidney failure, heart attack, or diabetic ketoacidosis (DKA), may be eligible to file an Invokana lawsuit against the drug manufacturers to recover damages.
Invokana lawsuits claim that Janssen Pharmaceuticals, Inc. failed to provide adequate warnings on their product labels, failed to conduct adequate safety studies before releasing the drug onto the market, and defectively designed the drug as an appropriate treatment for type 2 diabetes.
Plaintiffs may assert that had the company taken the proper precautions during product development, patients would not have been exposed to a potentially unsafe drug, and would not have had to undergo the difficult consequences.
FDA Warns of Invokana Ketoacidosis
In May 2015, the Food and Drug Administration (FDA) issued a drug safety communication alerting doctors and patients to the fact that Invokana, Farxiga, and Jardiance could lead to DKA, “a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.”
The FDA released the warning after receiving reports of 20 patients taking these drugs who developed DKA between March 2013 and June 2014. All required emergency room visits or hospitalization for treatment. The FDA has continued to receive more such reports.
These reports were unusual because DKA is more likely to occur in patients with type 1 diabetes. These patients often have inadequate insulin levels to process glucose, so the body burns fat for fuel instead. That process creates byproducts in the form of ketones, which are acidic.
Usually the kidneys flush the ketones out, but if kidneys can’t keep up with the supply, the blood becomes too acidic, leading to symptoms like nausea and vomiting, difficulty breathing, abdominal pain, confusion, and unusual fatigue. In type 1 diabetics, DKA is typically accompanied by high blood sugar levels.
In these 20 reports, however, the patients had type 2 diabetes, and only slightly increased blood sugar levels. That led the FDA to believe that the problem may be with Invokana and the other drugs in the same class, because they interfere with kidney function.
How Invokana Interferes with Kidney Function
Invokana belongs to a new class of drugs called “sodium-glucose co-transporter 2 (SGLT-2) inhibitors.” These drugs lower blood sugar levels by causing some glucose to be flushed out of the body through the urine.
Typically, the kidneys clean the blood of waste, flush the waste out through the urine, and return the blood to the body, reabsorbing the glucose. Invokana and other SGLT-2 inhibitors interfere with the kidney’s ability to reabsorb glucose, so that some of that glucose is flushed away.
Janssen Pharmaceuticals, Inc. submitted a group of nine Phase III clinical trials to the FDA when seeking approval for Invokana. The trials showed that Invokana did reduce blood sugar levels, but there was also a significant increased risk for kidney impairment and fungal infections, including urinary tract infections.
Early studies on the drug also raised questions about how it may affect the cardiovascular system, bone health, liver health, and pregnancy outcomes. One clinical study on patients with high risk of cardiovascular disease (CANVAS), for example, found that 13 patients suffered a major cardiovascular event (like a heart attack or stroke), compared to only one patient on placebo within the first thirty days of treatment. These results suggested an early period of enhanced cardiovascular risk associated with the use of the drug.
With respect to the trial cited by the FDA reviewer, the FDA concluded that “any imbalance in results during the first 30 days or the trial” in question “may be attributable to chance or may have been caused by an early increase in the risk of MACE [major adverse cardiovascular events]-plus associated with canagliflozin among subjects with high background cardiovascular risk.” The FDA went on to note that “There was no evidence of an increased risk of MACE-plus associated with canagliflozin after 30 days” in the trial.
Experts on the FDA panel noted that studies did not evaluate long-term risks with the medication, and that taking it for a long time may increase risk of kidney problems. Significantly, five out of fifteen Panel Members on the FDA Advisory committee who reviewed the clinical trial research, voted against FDA approval of the drug.
Despite the concerns, the FDA approved Invokana in March 2013. FDA approval came with a condition—that the manufacturer conduct additional studies to answer some of the safety questions raised above. Patients considering an Invokana lawsuit are likely to point out that these studies should have been done prior to the drug’s approval.
ISMP Provides Evidence for a Potential Invokana Lawsuit
The Institute for Safe Medication Practices (ISMP) regularly monitors prescription drugs, how they’re performing on the market, and any potential safety concerns. They also release a quarterly report detailing their findings. Within just a year of its release, Invokana showed up in the ISMP’s QuarterWatch for the second quarter of 2014. The authors noted that the drug had been linked to 457 adverse event reports—a higher number than for 92 percent of the drugs monitored by the group. Those reports linked Invokana to the following serious side effects:
- kidney failure or impairment
- dehydration and fluid imbalances
- kidney stones
- urinary tract infections
- abnormal or other weight loss
- serious hypersensitivity, which involved symptoms like rapid swelling of the tongue, lips, face, or throat; skin rashes; and skin exfoliation
Plaintiffs involved in an Invokana lawsuit are likely to use this report as evidence of Janssen’s negligence, for it suggests that the company failed to warn about some of the serious side effects that could result from ingestion of the drug. Even the ISMP questioned the wisdom of broadly distributing the drug before adequate safety studies were completed, stating in their report: “[a]lso, early signals for a new kind of diabetes drug, canagliflozin (INVOKANA) raise questions about whether enough is known about this agent to be assured that its benefits outweigh its risks.”
Public Citizen Expresses Concern About Invokana’s Safety
There were a lot of red flags raised when the FDA was reviewing Invokana for potential approval, but these were ignored. Public Citizen, a watchdog group, was one of the ones to raise a hand of dissent. Dr. Sidney Wolfe, director of health research, expressed concern because the drug was different—it lowered
blood glucose in a completely different way than previous type 2 diabetes drugs. He cautioned that because of its newness, there were sure to be undiscovered risks.
“The fact that the drug works by a uniquely new mechanism to lower blood sugar has not spared of a whole set of unique new risks,” he said.
Subsequent studies seemed to echo his concerns, as they discovered surprising results from the new drugs class of SGLT2 inhibitors, including Invokana. Researchers expected the drugs to lower blood glucose levels, which they did. What they did not expect was that the medications would cause the body to increase production of glucose and glucagon (a hormone that raises blood sugar levels) in order to compensate for the drug’s effect.
Two studies in 2014 (Merovci et al. and Ferrannini et al.) found that this was the case, though the overall effect was still a reduced blood glucose level.
Potential Invokana Side Effects
Invokana and other SGLT2 inhibitors have been linked with the following:
- Kidney stones
- Kidney failure
- Heart attack
- Urinary tract infections and yeast infections
- Allergic reactions
- Increased LDL “bad” cholesterol
- Dehydration and fluid imbalances
“This is not a drug I’d be enthusiastic about,” Dr. David M. Nathan of Harvard Medical School, Boston, told Medscape.
Allegations Raised in Invokana Lawsuits
Patients who took Invokana and related drugs and then were hospitalized for problems like kidney failure, ketoacidosis, or heart attack, may be entitled to compensation through an Invokana lawsuit. Families of loved ones who suffered from wrongful death because of Invokana may also deserve compensation.
Invokana lawyers are following the evidence that seems to suggest Janssen Pharmaceuticals, Inc., put profits before consumer safety. Drug manufacturers have a responsibility for making sure their drugs are safe for the majority of people before releasing them on the market, and at the very least, must provide adequate warnings as to the risks so that doctors and patients can make informed decisions.
In this case, based on the information that has become available regarding the risk associated with Invokana , we allege that Janssen Pharmaceuticals, Inc., and the other manufacturers of SGLT2 inhibitors, were negligent in:
- Failing to warn about all the potential risks and their seriousness.
- Failing to conduct adequate studies on large enough numbers of people and in diverse populations to properly determine the risks.
- Misrepresenting the safety and efficacy of Invokana (and SGLT2 inhibitors).
- Defectively designing a product that was then prescribed to hundreds of thousands of people.
- Withholding important safety information concerning Invokana.
- Once made aware of the risks, failing to implement an Invokana recall (and recall of the other SGLT2 inhibitors).
An Invokana Lawyer Can Help
Chaffin Luhana is currently investigating Invokana lawsuits. If you or a loved one suffered serious side effects after taking this drug, our national Invokana attorneys may be able to help. We are a plaintiffs-only firm dedicated to protecting individuals harmed by drug companies and other entities charged with protecting public safety. We are happy to give you a free case consultation. Call today at 1-888-316-2311.