FDA Warns Invokana May Lead To Ketoacidosis

By: Marilyn McGoldrick, Esq.

The Food and Drug Administration recently issued a Drug Safety Communication warning doctors and patients that taking the new class of diabetes drugs known as SGLT2 inhibitors — including Invokana — may lead to high levels of blood acids called ketones, a serious medical condition called ketoacidosis. Diabetic ketoacidosis can cause a host of medical problems, and in the most severe cases can lead to a diabetic coma and death.  Contact the Boston law firm of Thornton Law Firm LLP online or call us toll-free 888-491-9726 for a free Invokana consultation with a recognized leader in drug and medical device litigation.

Invokana and other sodium-glucose-cotransporter-2 drugs (SGLT2 inhibitors) work by causing excessive blood sugar to leave the body through the urine, lowering the body’s blood glucose levels. SGLT2s are prescribed to Type 2 diabetes patients and are popular because they also can lower blood pressure and make it easier for the patient to lose weight. SGLT2 inhibitors on the market include:

Brand Name Active Ingredients Manufacturer
Invokana Canagliflozin Johnson & Johnson
Invokamet Canagliflozin & Metformin Johnson & Johnson
Farxiga Dapagliflozin AstraZenica
XigduoXR Dapagliflozin & Metformin extended release AstraZenica
Jardiance Empagliflozin Lilly & Boehringer-Ingelheim
Glyxambi Empagliflozin & Linagliptin Lilly & Boehringer-Ingelheim

Johnson & Johnson’s Invokana, marketed in the U.S. by Janssen Pharmaceuticals, was the first SGLT2 approved by the FDA; it went on the market in March of 2013. In the first year that SGLT2 drugs were prescribed to diabetes patients, the Institute for Safe Medication Practices identified hundreds of complaints about users suffering serious side effects, including renal (kidney) failure or impairment; kidney stones, fluid/electrolyte issues, primarily dehydration; urinary tract infections, weight loss, hypotension (low blood pressure); and hypersensitivity.

In May 2015 the FDA warned that patients should be alert to the symptoms of ketoacidosis, and seek medical attention immediately if they experience “difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness” while taking SGLT2 diabetes drugs such as Invokana. The FDA has received over 20 complaints of ketoacidosis from patients taking SGLT2s:

“A search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014 (see Data Summary). All patients required emergency room visits or hospitalization to treat the ketoacidosis. Since June 2014, we have continued to receive additional FAERS reports for DKA and ketoacidosis in patients treated with SGLT2 inhibitors.”

If you have taken Invokana or one of the other SGLT2 diabetes drugs and have experienced side effects, you should contact your physician immediately for diagnosis and treatment. If you have been diagnosed with ketoacidosis or any other serious side effects after taking Invokana or the other SGLT2 diabetes drugs, you may have a legal claim. Call the Invokana lawyers at Thornton Law Firm at our toll free number 888-491-9726 or contact us online for a free, no-obligation review of your case. Like all legal claims, there are strict time limits for taking legal action, so do not delay seeking legal advice.

Report: $2.3 Billion Settlement Of Actos Lawsuits By Takeda

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by Marilyn T. McGoldrick, Esq.

Takeda Pharmaceuticals executives have reportedly offered more than $2.3 billion dollars to resolve the more than 8,000 lawsuits alleging that it hid the bladder cancer risks of its popular diabetes drug Actos. The settlement must still be approved, but reportedly the details of the settlement are final. If you or a loved one developed bladder cancer after taking Actos for diabetes, call the Actos lawyers at Thornton Law Firm at 888-341-1405 or tell us your story here for a free consultation.

Actos (piaglitazone) is prescribed for patients for Type 2 diabetes to regulate blood glucose. It has been on the market since 1999 and has accounted for billions of dollars in sales for Takeda and Eli Lilly, its U.S. marketing partner. Sales of Actos peaked at $4.5 billion dollars in 2011 and constituted 27% of Takeda’s revenue.

More than 3500 lawsuits are pending in federal court in Louisiana, and 4500 are pending in other state courts. In the lawsuits, Takeda is accused of covering up its own data showing that Actos raises the risk of bladder cancer in patients. The FDA required a bladder cancer warning to be added to the label for Actos in March 2011 after analyzing the scientific data. However, documents produced by Takeda in the Actos litigation revealed Takeda knew of that link as early as 2004 and took measures to conceal the information from doctors and patients.

Takeda stands accused of destroying documents it was ordered to produce by the federal court. Last summer Federal Court Judge Rebecca Doherty ruled that Takeda had deliberately destroyed the files of 46 corporate representatives whose documents would have helped plaintiffs prove that Actos caused bladder cancer and that Takeda had engaged in a deliberate attempt to cover up that fact.

In April of last year, a federal jury in Louisiana awarded a man who developed bladder cancer after taking Actos $9 billion dollars in punitive damages against Takeda. Although the award was later reduced on appeal to $36.8 million dollars, certainly the risk of such large jury awards has led to this reported settlement. In total, 9 trials have gone to verdict alleging Actos caused bladder cancer, and the plaintiff prevailed in 5 of those cases.

Reports indicate the settlement will amount to more than $287,000 per claim. Actos users whose cases warrant greater compensation can opt out and continue to litigate in court. According to Bloomberg Business, an individual’s final settlement may be reduced by certain factors, including age, smoking history and exposure to toxins. The settlement reportedly allows Takeda to walk away from the agreement if less than a certain percentage plaintiffs of agree to participate.

If you believe you or someone you love developed bladder cancer after taking Actos for diabetes, call the Actos lawyers at Thornton Law Firm on our toll free number 888-341-1405 or tell us your story online for a free, confidential evaluation of your legal claim. All legal claims have strict time limits so do not delay seeking legal advice.

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