Invokana Diabetes Drug Plaintiffs Seek Product Liability MDL in New Jersey

invokana-warning kidney-damageDozens of plaintiffs who suffered kidney damage or ketoacidosis have filed a motion to create new MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in federal court in New Jersey.

There are at least 56 actions pending in 11 different judicial districts against defendants Johnson & Johnson of New Brunswick, NJ, Janssen Pharmaceutical Inc. of Titusville, NJ (a J&J subsidiary) and Tanabe of Osaka, Japan.

The motion proposes that the Judicial Panel on Multidistrict Litigation (JPML) appoint Judge Brian R. Martinotti in the US District of New Jersey. He is already supervising 36 Invokana cases. The plaintiff’s attorneys are Christopher A. Seeger and Jeffrey Grand of Seeger Weiss in New York

Invokana went on sale in 2013 to treat type 2 diabetes by inhibiting renal glucose reabsorption with the goal of lowering blood glucose. Canagliflozin is a member of the gliflozin class of pharmaceuticals, also known as sodiumglucose cotransporter 2 (“SGLT2”) inhibitors.

Off label marketing

The defendants marketed and continue to market Invokana for off label purposes, including weight loss, reduced blood pressure, and improved glycemic control in type 1 diabetics.

In June 2016, the FDA released a safety announcement concerning canagliflozin and dapagliflozin, strengthening the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

The FDA added a further warning for ketoacidosis, including “Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose cotransporter-2 (SGLT2) inhibitors, including INVOKANA.”

The FDA added even more warnings in August 2016. Also see: Health Canada Warns of Diabetic Ketoacidosis from Invokana Diabetes Drug

The federal court in New Jersey has been home to mass tort litigation involving the Zimmer Durom Hip Cup, Tropicana Orange Juice Marketing, Vytorin/Zetia Marketing, and Hypodermic Products Antitrust litigation.

Judge Martinotti was the mass tort judge in New Jersey state court in Bergen County from 2009 to 2016. In that position he supervised litigation involving Mirena Yaz, Yasmin, Ocella, and the DePuy ASR Hip Implant.

The motion will likely be heard at the JPML next meeting on Dec. 1.

 

 

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Invokana Patients Seek Consolidation of Claims against Janssen into a New MDL

invokana-warning kidney-damageSeveral Invokana plaintiffs who sued Janssen Pharmaceuticals after they suffered severe kidney damage have filed a motion in federal court to consolidate all the claims into a multidistrict litigation docket.

The request to the Judicial Panel on Multidistrict Litigation is a critical first step in turning individual claims into a wide-reaching mass tort.

Currently, there are at least 56 actions pending in 11 different judicial districts alleging similar wrongful conduct on the part of defendants.

The movants propose the judge should be US District Judge Brian R. Martinotti in New Jersey, in part because Janssen and its parent company Johnson & Johnson are headquartered in the state. Judge Martinotti has supervised litigation involving Mirena, Yaz, Yasmin and the DePuy Hip, and has 36 of the Invokana cases already on his docket.

1.5 million prescriptions

The motion follows a safety warning by the FDA on June 17 strengthening the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, the FDA revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.

Further warnings were added to the label in August 2016. The new warnings stated that fatal cases of ketoacidosis have been reported in patients taking Invokana. The FDA advised doctors to inform patients that ketoacidosis is a serious life-threatening condition.

In the year from October 2014 to September 2015, 1.5 million prescriptions were written for either canagliflozin or dapagliflozin.

“SGLT2 inhibitors, including Invokana, are designed to inhibit renal glucose reabsorption with the goal of lowering blood glucose. As a result, excess glucose is not metabolized but instead is excreted through the kidneys of a population of consumers already at risk for kidney disease,” the motion states. “Though Invokana is indicated for only improved glycemic control in type 2 adult diabetics, defendants have marketed and continue to market Invokana for off-label purposes, including but not limited to weight loss, reduced blood pressure, and improved glycemic control in type 1 diabetics.”

“Defendants engaged in aggressive, direct-to-consumer and physician marketing and advertising campaigns for Invokana. However, consumers of Invokana were misled as to the drug’s safety and efficacy, and as a result have suffered serious and dangerous injuries,” the motion states.

The motion was filed by Christopher A. Seeger and Jeffrey Grand of Seeger Weiss LLP in New York. Notices of appearance in the MDL are due by Oct. 5 and responses to the motion are due by Oct. 12.

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Health Canada Warns of Diabetic Ketoacidosis from Invokana Diabetes Drug

invokana-warning kidney-damageHealth Canada, the country’s equivalent of the US Food and Drug Administration, warned healthcare professionals about the risk of diabetic ketoacidosis caused by SGLT2 Inhibitors, including Invokana, (canagliflozin), Farxiga (dapagliflozin), Xigduo (dapagliflozin/metformin), and Jardiance (empagliflozin).

The leading case is Arthur Portnoff V. Janssen Pharmaceuticals, Inc., Janssen Research and Development, LLC, Johnson & Johnson Co., and Mitsubishi Tanabe Pharma Corp., Case ID: 151200653, filed In the Philadelphia Court of Common Pleas. For more info read:

FDA strengthens kidney warnings for diabetes medicines Invokana, Invokamet, Farxiga and Xigduo XR

The warning was issued to healthcare professionals including internal medicine specialists, endocrinologists, cardiologists, nephrologists, general or family practitioners, emergency healthcare professionals, critical care physicians, certified diabetes educators and pharmacists.

Key messages

  • Serious, sometimes life-threatening and fatal cases of diabetic ketoacidosis (DKA) have been reported in patients on sodium glucose co-transporter 2 (SGLT2) inhibitors for type 1 and type 2 diabetes.
  • In a number of these cases, the presentation of the condition was atypical with only moderately increased blood glucose levels observed.
  • SGLT2 inhibitors are NOT indicated for the treatment of type 1 diabetes mellitus and should not be used in type 1 diabetes.
  • It is recommended that:
    • if DKA is suspected or diagnosed, treatment with SGLT2 inhibitors should be discontinued immediately.
    • SGLT2 inhibitors should not be used in patients with a history of DKA.
    • in clinical situations known to predispose to ketoacidosis (e.g. major surgical procedures, serious infections and acute serious illness), consideration be given to temporarily discontinuing SGLT2 inhibitor therapy.
    • patients be informed of the signs and symptoms of DKA and be advised to immediately seek medical attention if they develop them.
    • caution be used before initiating SGLT2 inhibitor treatment in patients with risk factors for DKA.

A life-threatening condition

Clinical trial and post-market cases of DKA, a serious, life-threatening condition requiring urgent hospitalization have been reported in patients with type 1 and type 2 diabetes mellitus on SGLT2 inhibitor treatment.

In a number of these reports, the presentation of the condition was atypical with only moderately increased blood glucose levels observed. Such atypical presentation of DKA in patients with diabetes could delay diagnosis and treatment.

Products affected
Brand Name Medicinal Ingredients Manufacturer
INVOKANA® canagliflozin Janssen Inc.
FARXIGA® dapagliflozin AstraZeneca Canada Inc.
XIGDUO® dapagliflozin and metformin AstraZeneca Canada Inc.
JARDIANCE empagliflozin Boehringer Ingelheim (Canada) Ltd.

Background information

Sodium glucose co-transporter type 2 (SGLT2) inhibitors are a class of drugs indicated as oral antihyperglycemic agents for the treatment of patients with type 2 diabetes.

The underlying mechanism for SGLT2 inhibitor-associated ketoacidosis is not clearly established. DKA usually develops when insulin levels are too low to prevent ketoacid accumulation. DKA occurs most commonly in patients with type 1 diabetes and is usually accompanied by high blood glucose levels (>14 mmol/L). However, the cases referred to above also concern patients with type 2 diabetes and in a number of cases blood glucose levels were only slightly increased, in contrast to typical cases of DKA.

The majority of the patients described in the above reports required hospitalization. To date, many of them have occurred during the first 2 months of treatment.  In many cases, just before or at the same time as the ketoacidosis occurred, patients experienced dehydration, low food intake, weight loss, infection, surgery, vomiting, a decrease in their insulin dose or poor control of diabetes.

A substantial proportion of the cases concerned use of SGLT2 inhibitors in patients with type 1 diabetes. SGLT2 inhibitors are NOT indicated for treatment of type 1 diabetes mellitus.

Who is affected

Information for consumers

Diabetic ketoacidosis (DKA) is a serious complication of diabetes caused by low insulin levels. Rare cases of this condition, including life-threatening and fatal ones, have occurred in patients taking SGLT2 inhibitors [INVOKANA®(canagliflozin), FORXIGA® (dapagliflozin), XIGDUO® (dapagliflozin/metformin), JARDIANCETM (empagliflozin)] for type 1 and type 2 diabetes.

A number of these cases have been unusual, with patients having blood sugar levels that are not as high as typically expected in DKA, which can lead to a delay in diagnosis and treatment.

Patients taking any of these medicines should be aware of the symptoms of DKA, including loss of appetite, nausea or vomiting, stomach pain, feeling very thirsty, rapid breathing, confusion, feeling unusual tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.

Patients should immediately seek medical advice if they develop any of these symptoms. Patients should also inform their healthcare professional about medical issues or factors (see below) that may predispose them to ketoacidosis.

SGLT2 inhibitors are NOT indicated for treatment of type 1 diabetes mellitus and should not be used in type 1 diabetes.

Information for health care professionals

Before initiating treatment with SGLT2 inhibitors, factors in the patient history that may predispose to ketoacidosis should be considered. These factors include:

  • patients on a very low carbohydrate diet (as the combination may further increase ketone body production),
  • an acute serious illness,
  • pancreatic disorders suggesting insulin deficiency (e.g., type 1 diabetes, history of pancreatitis or pancreatic surgery),
  • sudden insulin dose reduction (including insulin pump failure),
  • alcohol abuse,
  • conditions that lead to severe dehydration,
  • hospitalization for major surgery or serious medical illness.

SGLT2 inhibitors should be used with caution in these patients. In addition, patients should be informed of these risk factors.

SGLT2 inhibitors should not be used in patients with a history of DKA.

A substantial proportion of the cases concerned off-label use in patients with type 1 diabetes. Prescribers are reminded that type 1 diabetes is NOT an approved indication for SGLT2 inhibitors.

Patients on SGLT2 inhibitors should be tested for ketones when they present with symptoms of acidosis in order to prevent delayed diagnosis and patient management.  If ketoacidosis is suspected, treatment with SGLT2 inhibitors should be discontinued.

Prescribers should inform patients of signs and symptoms of metabolic acidosis and advise them to immediately seek medical advice if they develop such signs and symptoms.

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