U.S. health regulators are currently reviewing reports linking Invokana and other SGLT2 inhibitor Type 2 diabetes drugs to diabetic ketoacidosis. The Rottenstein Law Group is an Invokana law firm that advocates on behalf of individuals who have suffered serious side effects that may be associated with Invokana and other antidiabetic medications that belong to the SGTL2 inhibitor class, including Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.
If you were treated with Invokana or another SGLT inhibitor medication, and believe that it caused you harm, contact RLG immediately for a free, confidential Invokana lawsuit consultation. We will evaluate your case for free and do all that is necessary to help you obtain fair compensation for the harm you’ve suffered.
What is Invokana and What is it Prescribed For?
Invokana is the brand name for a Type 2 diabetes drug called canagliflozin. Brought to market in March 2013, Invokana was the first SGLT2 inhibitor approved for sale in the U.S. It is manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson. Janssen also markets Invokamet, a combination of canagliflozin and metformin.
Since its launch, Invokana has become an important medication in Janssen’s product line. According to Reuters the medication garnered $340 million in sales during the third quarter of 2015, putting Invokana on track to become a blockbuster.
Invokana and other SGLT2 inhibitors are indicated to improve glycemic control in people with Type 2 diabetes. While these medications have not been approved for people with Type 1 diabetes, drugs in the SGLT2 inhibitors class are sometimes prescribed off-label to these patients. However, SGLT2 inhibitors have not been proven safe and effective for this purpose.
Invokana works by inhibiting SG LT2 (sodium-glucose co-transporter 2), a glucose transporter located in the proximal tubule in the kidneys that is responsible for 90% of glucose reabsorption. By blocking SGLT2, drugs like Invokana facilitate the removal of glucose from the body via urine, resulting in a decrease in blood glucose levels.
Invokana and Other SGLT2 Inhibitors May Cause Life-Threatening Side Effects
In May 2015, the U.S. Food & Drug Administration (FDA) warned that Invokana and other SGLT2 inhibitors may be associated with a potentially life-threatening condition called diabetic ketoacidosis (DKA). According to the agency, its adverse event database had logged 20 reports of this condition in patients using SGLT2 inhibitors between March 2013 and June 6, 2014. Additional reports have also been received by the FDA since June 2014. The agency has advised SGLT2 inhibitor patients to seek medical attention immediately if they experience symptoms associated with DKA, including difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.
Diabetic ketoacidosis, also known as ketosis, acidosis, and ketoacidosis, occurs when toxic acids called ketones are allowed to build up in the blood stream. If not recognized and treated quickly, ketoacidosis may result in diabetic coma or death. All of the cases reported to the FDA in regards to SGLT2 inhibitors resulted in the need for emergency medical treatment or hospitalization. The agency noted that diabetic ketoacidosis most commonly occurs in patients with Type 1 diabetes and is usually accompanied by high blood sugar levels. But the cases reported to the agency’s database where atypical, in that the majority involved Type 2 diabetics. Blood sugar levels, when reported, were only slightly increased.
Despite the dangerous consequences associated with diabetic ketoacidosis, the FDA has not found it necessary to announce an Invokana recall or a recall of any other SGTL2 inhibitor medication. Rather, the agency is trying to determine whether changes are needed in the prescribing information for this class of medications.
Regulators oversees are also investigating a potential link between drugs like Invokana and the onset of diabetic ketoacidosis. According to the European Medicines Agency, the EudraVigilance database had received 101 reports of DKA in Type 2 diabetics treated with SGLT2 inhibitors as of May 19, 2015. HealthCanada, which announced its own review in June 2015, has received one report of the condition in a patient taking an SGLT2 inhibitor for Type 2 diabetes.
Since the FDA announced its safety review, alleged victims have begun to pursue Invokana lawsuits in U.S. courts. One of the first was filed on October 26, 2015, in the U.S. District Court, Eastern District of California, by a woman who was hospitalized for ketoacidosis not long after she was prescribed Invokana by her doctor to treat Type 2 diabetes. Among other things, the Invokana lawsuit claims that Johnson & Johnson and Janssen failed to adequately warn physicians about the risks associated with the medication and the monitoring required to ensure their patients’ safety. (Case No. 2:15-at-01102)
RLG’s Lawyers Will Make Things Easier
Taking a pharmaceutical company to court to obtain compensation for the harm you’ve suffered is a complicated and intimidating process. The Invokana lawyers at the Rottenstein Law Group believe that the victims of serious drug side effects shouldn’t have to endure more hardship in order to be made whole again. That’s why we do everything we can to simplify the legal process, including filing an Invokana lawsuit on your behalf if necessary.
If you have taken Invokana and believe it harmed you, contact RLG today: 1 (888) 976-8529