When the U.S. Food and Drug Administration first approved Invokana in 2013, it was hailed as a breakthrough drug to treat adults with type 2 diabetes. The medication ushered in a new class of drugs called SGLT2 inhibitors that were meant to be a safe and effective treatment option.
Within months of approval, users started reporting serious and unexpected side effects that resulted in hospitalization, amputations of the limbs, and even death. This prompted the FDA to take action by issuing several warnings about side effects.
But to those affected by Invokana, it was not enough.
Hundreds of people have filed lawsuits against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals. Plaintiffs are making several allegations against the companies, including a failure to warn of dangers, negligence, creating a defective drug, and more. The first trials are set to take place in September 2018.
Invokana, also known by its generic name canagliflozin, is the first in a class of drugs designed to treat type 2 diabetes called sodium glucose co-transporter 2 (SGLT2) inhibitors.
The prescription medication works by inhibiting SGLT2, a carrier responsible for the reabsorption of glucose back into the bloodstream. By stopping the carrier, less glucose is reabsorbed by the kidneys and more glucose is lost during urination. This ultimately leads to lower blood glucose levels in those with type 2 diabetes.
Invokana is designed to be used in conjunction with diet and exercise to improve glucose levels. It is usually taken by mouth once a day before the first meal. The recommended starting dose is 100 mg a day.
Invokana was in development by Mitsubishi Tanabe Pharma Corporation for more than a decade before it was licensed out to Janssen Pharmaceuticals, a division of Johnson & Johnson.1 Janssen submitted a new drug application to the FDA in May 2012. It offered a clinical development program with more than 10,000 patients as evidence of its safety and efficacy.
Invokana was formally approved by the FDA in March 2013 to improve glycemic control in adults with type 2 diabetes. It was the first SGLT2 inhibitor approved for use in the United States. In a March 2013 press release from Johnson & Johnson, the drug was hailed as a breakthrough treatment for diabetic adults.2
“We are delighted with the approval of INVOKANA™ because it provides a much-needed, new treatment option to help adults with type 2 diabetes and their physicians manage this disease,” Kirk Ways of Janssen Research & Development said at the time.
In 2014, additional SGLT2 inhibitors like Farxiga (dapagliflozin) and Jardiance (empagliflozin) were approved for use. The FDA also approved Invokamet, a combination of canagliflozin and metformin, in 2014. Two years later, an extended release version of that medication called Invokamet XR was approved.
SGLT2 inhibitors quickly rose in popularity. The FDA reported that between October 2014 and September 2015, around 1.5 million patients received prescriptions for Invokana and other SGLT2 inhibitors.3 Some groups estimated Invokana brought in hundreds of billions of dollars in sales.
Because of the nature of SGLT2 inhibitors and their effect on glucose levels in urination, one of the most common side effects is a change in urination. Users may notice an increase in urination and yeast infections in both men and women.
Here is a list of other common Invokana side effects:
Not long after Invokana was approved, people began reporting troubling side effects that were not on the drug’s label.
These are among the most serious side effects:
Concerns over Invokana’s link to a condition called ketoacidosis arose only a year after it was approved by the FDA. By May 2015, the FDA had issued a drug safety communication warning that SGLT2 inhibitors could cause the serious condition.4
Ketoacidosis occurs when the body produces high levels of blood acids called ketones, according to the Mayo Clinic.5 The condition required hospitalization for some patients.
Between March 2013 and June 2014, the FDA received 20 cases of ketoacidosis in patients taking SGLT2 inhibitors. All of them needed emergency room visits or hospitalization for treatment. Label changes were made to SGLT2 inhibitors to reflect the increased risk of ketoacidosis and severe urinary tract infections in December 2015.
Invokana was also connected to acute kidney injury. The FDA strengthened existing warnings about kidney injuries in SGLT2 inhibitors in June 2016 after it received more than a hundred cases.
Invokana also carries a significant risk of amputations of lower limbs. The FDA required Janssen to add a black box warning — the strongest warning — to Invokana’s labels for amputation risks in 2017.
The warning was prompted after two clinical trials found leg and foot amputations occurred twice as often in patients taking Invokana than those taking placebos.6 The trials found amputations of the toe and middle of the foot were most common. Amputations above and below the knee also took place.
Safety concerns about amputation risks led to several physicians and medical groups telling patients to stop taking the drug immediately.
Although warnings were added to reflect the dangers of Invokana in the years after its initial approval, countless people suffered severe side effects that resulted in kidney damage, amputation, hospitalization, and even death.
As a result, harmed parties have filed lawsuits against Johnson & Johnson and Janssen Pharmaceuticals. Plaintiffs have accused the makers of Invokana of concealing dangerous risks from consumers, failing to notify the public of side effects, manufacturing a defective product, and deceptive advertising.
More than a thousand lawsuits have been filed in federal and state courts around the country. In December 2016, about a thousand lawsuits were consolidated in New Jersey federal court by the U.S. Judicial Panel on Multidistrict Litigation after it found the actions all involved common factual questions.7
Not only does the creation of multidistrict litigation make the litigation more efficient but it also allows for the use of bellwether trials. A bellwether trial is a case that lets both sides test their arguments in front of a jury. The outcome of bellwether trials helps move litigation toward resolution, such as a settlement.
The first bellwether trials are expected to go to court in September 2018.
People continue filing lawsuits against Janssen over claims that Invokana caused them unexpected and severe side effects. Those who were injured by Invokana before warnings were added to the labels may still be eligible to file lawsuits and receive compensation for medical bills and pain and suffering.
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