Invokana, Forxiga & Jardiance Lawsuits
A potentially fatal side effect of SGLT2 Inhibitors is expected to lead to lawsuits against a handful of drug makers. The medications treat Type 2 diabetes but trigger dangerous levels of blood acids, which led the FDA to sound an alarm about the drugs.
FDA Warns About Ketoacidosis
The U.S. Food and Drug Administration (FDA) issued a warning about SGLT2 Inhibitors in May 2015. According to the warning, these Type 2 diabetes medications may lead to ketoacidosis, is a serious condition in which the body produces high levels of blood acids known as ketones. In 20 reported cases, patients developed ketoacidosis to the point of needing an emergency room visit or hospitalization.
If a patient experiences these symptoms, he or she should seek emergency medical treatment.
In the wake of the FDA warning, attorneys are taking cases concerning ketoacidosis involving the SGLT2 inhibitor class of medications.
|The FDA warning recommends people taking SGLT2 medications look for symptoms of ketoacidosis. Symptoms include:|
Drugs Included in Possible Lawsuits
SGLT2 Inhibitors are a relatively new type of diabetes medication first released in March 2013. The SGLT2 inhibitor medications on the market include the following:
- Canagliflozin, marketed as Invokana, manufactured by Johnson & Johnson’s Janssen Pharmaceuticals
- Canagliflozin and Metformin, marketed as Invokamet, also manufactured by J&J’s Janssen Pharmaceuticals
- Dapagliflozin, marketed as Farxiga, manufactured by AstraZeneca
- Dapagliflozin and Metformin extended-release, marketed as Xigduo XR, also manufactured by AstraZeneca
- Empagliflozin, marketed as Jardiance, manufactured by Lilly and Boehringer-Ingelheim
- Empagliflozin and Linagliptin, marketed as Glyxambi, manufactured by Lilly and Boehringer-Ingelheim
This class of medications works by triggering the kidneys to release excess blood glucose through the urine. It is indicated for treatment of patients with Type 2 diabetes, which cannot be controlled through diet and exercise. It is not to be prescribed to those with Type 1 diabetes or for treatment of diabetic ketoacidosis.
Diabetic ketoacidosis happens when the body does not have enough insulin to manage glucose levels. The body begins burning fatty acids, which results in a waste product, acidic ketone bodies. These ketones are what trigger the symptoms of ketoacidosis. Those symptoms include vomiting, dehydration, confusion, fatigue, and abdominal pain.
In rare cases, untreated ketoacidosis can cause to coma and even death. While no deaths have been reported with the use of the SGLT2 inhibitor drugs, the danger does exist.
Drug Safety Group Warns of Invokana Risks
On top of the FDA warnings, more concerns are being brought forward about Invokana, one of the SGLT2 inhibitor drugs. The Institute for Safe Medication Practices (ISMP)’s May 6, 2015, edition of Quarter Watch warns about a number of adverse reactions being reported about Invokana.
In the first year after Invokana was released, more than 450 serious adverse event reports were filed. Many of these reports were related to renal toxicity:
- 54 reports of kidney failure or impairment
- 54 cases of severe dehydration or fluid imbalance
- 11 cases of kidney stones
- 50 cases of urinary tract infections
- 52 cases of abnormal weight loss
Besides renal related issues, 50 cases of hypersensitivity (allergic response) to the drug were reported. Symptoms of the hypersensitivity included rapid swelling of the tongue, throat, lips or face, plus skin rashes and skin exfoliation.
There are questions whether the benefits of Invokana outweigh its potential risks. During the drug trials prior to the FDA approval in 2013, patients were found to have a higher incidence of developing fungal infections than the normal population. Also, animal studies found that long-term exposure to the medication within Invokana could lead to long-term kidney damage, testicular and kidney cancers, and abnormalities in the bones.
Should You File an SGLT2 Inhibitor Lawsuit?
Attorneys are actively accepting cases involving the development of ketoacidosis and the use of these SGLT2 inhibitors. It is important for anyone who has dealt with this issue to seek legal representation immediately.
If you were harmed after taking an SGLT2 inhibitor drug, you should contact an attorney as soon as possible. The attorney can review your case and see if you have a case against one of the drug manufacturers.
Ultimately the decision to file suit is your decision. But, don’t make that decision without knowing all your options. If your health has been adversely affected by one of these medications, you should not dismiss the idea of receiving compensation easily.
- FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. (2015, May 15). Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm
- Institute for Safe Medication Practices. (2015, May 6). Unanswered Questions about Canagliflozin (INVOKANA). Quarter Watch, 2. Retrieved from http://www.ismp.org/QuarterWatch/pdfs/2014Q2.pdf
- Mayo Clinic. (2012, October 23). Diabetic ketoacidosis – Mayo Clinic. Retrieved from http://www.mayoclinic.org/diseases-conditions/diabetic-ketoacidosis/basics/definition/con-20026470
- NPS MedicineWise. (2103, December). Dapagliflozin (Forxiga) and canagliflozin (Invokana). NPS Radar. Retrieved from https://www.nps.or.au/__data/assets/pdf_file/0008/238445/Dapaglifozin-and-canagliflozin.pdf