Invokana Diabetes Drug Under Fire for KetoacidosisApr 21, 2017
Invokana is a type 2 diabetes drug that is coming under scrutiny as lawsuits mount from plaintiffs coming forward alleging that the manufacturers failed to warn about the risk of ketoacidosis. Diabetic ketoacidosis is a serious condition prompted by the build-up of ketone bodies, leading to acidic blood levels. This can result in a diabetic coma or even death.
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (J&J) has been named for omitting important safety information from the U.S. Food and Drug Administration (FDA). Plaintiffs claim that rather than warning the public of serious risks, the company conducted nation-wide marketing campaigns promoting the drug.
National law firm Parker Waichman has extensive and successful experience representing clients in pharmaceutical litigation. Attorneys at the firm are available to answer any questions for individuals seeking information about filing a potential lawsuit.
What is Type 2 Diabetes
Type 2 diabetes occurs when the body no longer responds to insulin. This allows cells to take up glucose (sugar) for energy. Therefore, the cell is starved and the body begins to break down fat instead. When the body breaks down fat for energy, it produces ketone bodies making the blood more acidic. Patients suffering from ketoacidosis may have difficulty breathing, nausea, vomiting, abdominal pain, confusion, unusual fatigue, and sleepiness.
Appropriate medication used in collaboration with diet and exercise helps lower blood sugar levels in adults diagnosed with type 2 diabetes.
Untreated type 2 diabetes may lead to serious health problems, including blindness, nerve and kidney damage, and heart disease.
The FDA warned about the risk of ketoacidosis with sodium-glucose cotransporter-2 (SGLT2) inhibitors in May 2015. The warning included canagliflozin (Invokana by J&J), dapagliflozin (Farxiga made by Astra Zenece), and empagliflozin (Jardiance made by Lilly/Boehringer). It also included three combination products that include an SGLT2 inhibitor: canagliflozin plus metformin (Invokana by J&J), dapagliflozin plus metformin extended release (Xigduo XR by AstraZeneca), and empagliflozin plus linagliptin (Glyxambi by Lilly/Boehringer).
In July 2016, the FDA strengthened the existing warning about the risk of acute kidney injury. Signs and symptoms of acute kidney injury include decreased urine output and increased leg and foot swelling.
A plaintiff who started taking Invokana in November 2014, at her doctor's recommendation, says SGLT2 inhibitors are defective, dangerous, and do not have proper warnings. The Pennsylvania woman has type-2 diabetes. In March 2015, the plaintiff says she was hospitalized with symptoms of nausea, vomiting, and dehydration. Her doctors diagnosed her with diabetic ketoacidosis.
The plaintiff currently believes this occurrence of ketoacidosis can be attributed to the Invokana she had been taking. She maintains she could have avoided this dangerous condition had Invokana's manufacturers issued an appropriate warning about the associated risk.
The plaintiff names as defendants in her Invokana lawsuit, Janssen Pharmaceuticals, Johnson & Johnson, Mitsubishi Tanabe, and their associated business entities, all of whom are allegedly connected to the manufacture and sale of Invokana.
In May 2015, the FDA issued a drug safety notification addressing the risk of ketoacidosis linked to SGLT2 inhibitors. The agency said that between March 2013 and June 2014, it received reports of 20 cases of ketoacidosis experienced by patients taking these medications. Ketoacidosis is considered a serious medical emergency and all patients reportedly required emergency room treatment or hospitalization.
In December 2015, the FDA followed up adding a new warning to the label for SGLT2 inhibitors including the risk of ketoacidosis. The FDA now advises patients to stop taking any SGLT2 inhibitor at once and seek medical attention if they should experience any ketoacidosis symptoms.
Dozens of plaintiffs have filed lawsuits who believe the manufacturers of Invokana and similar drugs had awareness about the risk of ketoacidosis but chose to keep that information from the public to avoid harming sales of their medications.
With expectation of more such claims emerging, the federal court system has created a multidistrict litigation (MDL) to handle them all. MDLs are frequently used for complex lawsuits in the interest of efficiency by consolidating lawsuits to be held in one court before one judge. This streamlines the process and helps to minimize court costs.
All relevant cases will be transferred to a federal court in the U.S. District Court for the District of New Jersey, where U.S. District Judge Brian R. Martinotti will oversee coordinated pretrial procedures.
Legal Help for Invokana Users
If you or someone you know suffered adverse side effects, such as ketoacidosis due to the use of Invokana, you may have valuable legal rights. The attorneys at Parker Waichman offer free, no-obligation case evaluations. For more information, contact our personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).