What is Invokana?
Invokana (canagliflozin) and Invokamet (canagliflozin/metformin) are SGLT2 inhibitors that were developed by Mitsubishi Tanabe Pharma Corporation for more than a decade before being licensed out to Janssen Pharmaceuticals, a division of Johnson & Johnson.
Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a group of drugs FDA-approved to lower blood sugar in adults with type 2 diabetes, in conjunction with diet and exercise. 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.
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.
How are people affected?
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.
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, as the kidneys work to expel the separated glucose. These common side effects include increased urination, yeast infections, UTIs, thirst, dry mouth, fatigue, and genital itching.
However, soon after the drug reached the market, adverse side effects became identified as attributable to it, yet consumers were neither told nor warned about the potential for dangerous side effects, including but not limited to:
- Ketoacidosis
- Kidney/renal failure and kidney damage
- Bone fractures
- Cardiovascular events
- Amputations of the lower limbs
Just over a year after Invokana’s approval, the Institute for Safe Medication Practices issued a report indicating a link between kidney damage, renal failure, and SGLT2 inhibitors.
By May 2015, the FDA had issued a drug safety communication warning that SGLT2 inhibitors could cause ketoacidosis, a medical condition where high levels of ketones are produced in the body. Ketoacidosis can result in a patient suffering from a diabetic coma, extended hospitalization, and even death. It develops when insufficient levels of insulin are produced within the body: without adequate insulin, the body breaks down fat as an alternative source of energy, which causes a buildup of toxic acids in the bloodstream called ketones.
In September 2015, the FDA revised the labels of Invokana and Invokamet to include information about bone fracture risk and decreased bone mineral density. The FDA added a warning about SGLT2 kidney side effects in June 2016, after more than 100 adverse event reports were submitted to the FDA.
In 2017 the FDA required Janssen to add a black box warning—the strongest warning—to Invokana’s labels for amputation risks. The warning was prompted after two clinical trials found leg and foot amputations occurred twice as often in patients taking Invokana as in those taking placebos. The trials found amputations of the toe and middle of the foot were most common, although amputations above and below the knee also took place.
What is the solution?
When untreated, type 2 diabetes can lead to severe problems, including blindness, nerve damage, kidney failure, heart disease, stroke, high blood pressure, and a range of other issues.
It is essential to keep your diabetes under control with both diet and exercise, as well as regular treatment with your primary physicians/endocrinologists, and to comply with all pharmaceutical and medical treatment. It is essential that you document any complaints or problems you may have, both for your medical treatment and for your claim.
How can TPLG help?
As a law firm designed to handle your specific type of case, we will guide you and your case through the legal system to ensure we get the best results possible. The types and amounts of damages an individual can expect to receive from a lawsuit against these manufacturers depend on the specific facts of the individual’s case, but if you have sustained injuries due to Invokana, we will generally be seeking:
- Past and future medical expenses that result from your injuries
- Past and future pain and suffering caused by the injuries, the treatment and the recovery process
- Past and future wage loss (if any)
- Past and future loss of capacity to earn money
- Punitive damages, if appropriate
Although multiple warnings were added to reflect the dangers of Invokana in the years after its initial approval, numerous people suffered severe side effects that resulted in kidney damage, amputation, hospitalization, and even death. As a result, harmed parties 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, withholding information from the FDA, and deceptive advertising misrepresenting the risks and benefits of taking the medication.
The cases were consolidated in New Jersey in December 2016 as part of a federal multidistrict litigation (MDL No. 2750) before U.S. District Judge Brian Martinotti. By 2018 more than 1,000 cases had been filed, and the first bellwether trials were scheduled for September 2018. Multidistrict litigation makes the litigation more efficient and allows for bellwether trials, in which test cases are selected from the filed complaints to go before a jury in order to gauge responses to the issue. As it is not practical to bring every case to trial, these results help shape the process of dealing with the remaining claims and ascertaining their value.
Injured by Invokana? Find out if you have a claim.
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