Invokana Cases Move Forward with Discovery Plan, Bellwether Case Selection, Scheduling of Trials

The federal multidistrict litigation overseeing hundreds of products liability lawsuits involving Invokana and Invokamet are moving forward in the U.S. District Court, District of New Jersey. On May 1, 2017, the court has established an initial discovery plan addressing, among other things, bellwether case selection protocol, scheduling and trial dates. The Court had previously indicated that the litigation’s first bellwether trials could begin in September 2018.

There are 288 lawsuits filed in MDL 2750 before US District Judge Brian R. Martinotti in IN RE: Invokana (Canagliflozin) Products Liability Litigation. Plaintiffs who suffered ketoacidosis or kidney damage allegedly related to the use of Invokana or Invokamet.  They accuse the drugs’ manufacturers of failing to warn patients about the serious risks potentially associated with the medications.

In an order dated May 5, 2017, the court has barred the filing of multi-plaintiff complaints, apart from those that name a derivative plaintiff, such as a spouse. Multi-plaintiff cases already pending in the litigation as of May 5 are to be severed.

“We are pleased that the Court is moving forward with plans for bellwether trials, as verdicts in these cases could give some insight into how other juries might decide similar lawsuits involving Invokana or Invokamet,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices.

FDA Boxed Warning

In related news, the FDA issued a safety alert on May 17 that Invokana and Invokamet have an increased risk of leg and foot amputations.

Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.

Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine.

Invokana and Invokamet Side Effects

Invokana was brought to market in March 2013, and was the first SGLT2 inhibitor approved by the U.S. Food & Drug Administration (FDA) to treat Type 2 diabetes. The agency approved Invokamet in November 2014. Both drugs lower blood glucose levels by preventing the absorption of sugar by the kidneys, thereby causing it to be eliminated via urine.

The FDA has since issued several safety alerts to warn of side effects potentially associated with the use of Invokana and other SGLT2 inhibitors. In December 2015, for example, the agency announced that the labels for all drugs in this class would be updated to include information about diabetic ketoacidosis, a potentially deadly complication related to the accumulation of toxic acids (ketones) in the bloodstream. The labels were also modified with information about life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that originate as urinary tract infections.

In June 2015, the FDA mandated stronger kidney warnings for several SGLT2 inhibitors, including Invokana and Invokamet, after the medications were cited in more than 100 reports of acute kidney injury.

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U.S. Invokana Sales Slide As Injury Lawsuits Mount

By Sandy Liebhard

Johnson & Johnson continues to face legal challenges over Invokana. In addition to slowing U.S. sales, the Type 2 diabetes drug continues to be the subject of a growing product liability litigation involving diabetic ketoacidosis and other side effects allegedly associated with its use.

According to Johnson & Johnson’s most recent earnings report, U.S. sales of Invokana fell by $50 million (16.8%) during the first quarter of 2017, to $270 million. However, sales were up 32% in international markets, to $37 million.

Invokana Side Effects

Brought to market in March 2013, Invokana was the first SGLT2 inhibitor approved in the U.S. to treat Type 2 diabetes. Johnson & Johnson also markets a sister diabetes medication called Invokamet, which also contains metformin.  These drugs work by preventing the absorption of glucose by the kidneys, resulting in its elimination from the body via urine.

Since Invokana’s approval, SGLT 2 inhibitors have been the subject of several of U.S. Food & Drug Administration (FDA) safety alerts:

  • September 2015: The agency announced that the labels for Invokana and Invokamet would be updated to include information about a possible increased risk of bone fractures.
  • December 2015: New warnings about diabetic ketoacidosis and serious urinary tract infections were added to the labels of all SGLT2 inhibitors, including Invokana and Invokamet.
  • May 2016: The FDA announced it was investigating a possible link between Invokana, Invokamet and an increased risk of lower limb amputations (mostly involving the toes).
  • June 2016. Kidney warnings already included on the labels of Invokana, Invokamet, Farxiga and Xigduo XR were strengthened after the drugs were linked to more than 100 reports of acute kidney injury.

Invokana Litigation

More than 230 Invokana lawsuits have been centralized in federal multidistrict litigation now underway in the U.S. District Court, District of New Jersey. All of the pending cases were filed by people who allegedly developed diabetic ketoacidosis, kidney damage and other serious complications due to treatment with Invokana or Invokamet.

US District Judge Brian R. Martinotti will convene “Science Day” on May 21. This event will give the parties the opportunity to inform the Court of the medical and scientific issues central to Invokana and Invokamet lawsuits in a non-adversarial and off-the-record setting.

The Court has also indicated its intention to begin bellwether trials in September 2018. These trials will act as test cases, and could provide insight into how juries might decide similar Invokamet and Invokana lawsuits in the future.


Sandy A. Liebhard, a founding partner at Bernstein Liebhard LLP, has represented plaintiffs in complex litigation for more than 20 years. As an author for RXInuryHelp.com, Mr. Liebhard has written extensively on the litigation involving proton pump inhibitors (Nexium, Prilosec, PrevAcid, etc.) and kidney injuries; Risperdal and gynecomastia; the Bair Hugger forced-air warming blanket; talcum powder and ovarian cancer; transvaginal mesh; power morcellators; defective hip implants; and more.

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Court Names Plaintiff’s Steering Committee for Invokana MDL

invokana-warning kidney-damageUS District Judge Brian Martinotti appointed the plaintiff’s steering committee for MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in New Jersey in Case Management Order #2. A total of 100 lawsuits have been filed in the MDL since the courts created it in December.

The attorneys compose “an array of highly skilled counsel with diverse backgrounds and experience which will provide the Court with an effective committee to advance this litigation in an efficient and just manner,” the judge said. They include:

Christopher A. Seeger (Co-Lead Counsel)
Seeger Weiss LLP
77 Water Street, 26th Fl.
New York, New York 10005
Phone: (212) 584-0700
Fax: (212) 584-0799
Email: cseeger@seegerweiss.com

Michael A. London (Co-Lead Counsel)
Douglas & London, P.C.
59 Maiden Lane, 6th Fl.
New York, New York 10038
Phone: (212) 566-7500
Fax: (212) 566-7501
Email: mlondon@douglasandlondon.com

James E. Cecchi (Liaison Counsel)
Carella, Byrne, Cecchi, Olstein, Brody & Agnello
5 Becker Farm Road
Roseland, New Jersey 07068
Phone: (973)994-1700
Fax: (973)994-1744
Email: jcecchi@carellabyrne.com

Ellen Relkin (Executive Committee)
Weitz & Luxenberg, P.C.
700 Broadway
New York, New York 10003
Phone: (212) 558-5500
Fax: (212) 344-5461
Email: erelkin@weitzlux.com

Hunter J. Shkolnik (Executive Committee)
Napoli Shkolnik, PLLC
360 Lexington Avenue, 11th Fl.
New York, New York 10017
Phone: (212) 397-1000
Fax: (646) 843-7603
Email: hunter@napolilaw.com

Timothy O’Brien (Executive Committee)
Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A.
316 South Baylen Street
Pensacola, Florida 32502
Phone: (850) 435-7084
Fax: (850) 436-6084
Email: tobrien@levinlaw.com

Ashley Brittain-Landers
Schlicter Bogard & Denton, LLP
100 South Fourth Street, Ste. 1200
St. Louis, Missouri 63102
Phone: (314) 621-6115
Fax: (314) 621-7151
Email: abrittain@uselaws.com

John Gomez
Gomez Law Firm
655 West Broadway, Ste. 1700
San Diego, California 92101
Phone: (619) 237-3490
Fax: (619) 237-3496
Email: john@thegomezfirm.com

Anthony D. Irpino
Irpino, Avin & Hawkins
2216 Magazine Street
New Orleans, Louisiana 70130
Phone: (504) 525-1500
Fax: (504) 525-1501
Email: airpino@irpinolaw.com

Holly H. Dolejsi
Robins Kaplan, LLP
800 LaSalle Avenue, Ste. 2800
Minneapolis, Minnesota 55402
Phone: (612) 349-8500
Fax: (612) 339-4181
Email: hdolejsi@robinskaplan.com

Danielle Ward Mason
Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.
218 Commerce Street
Montgomery, Alabama 36104
Phone: (800) 898-2034
Fax: (334) 954-7555
Email: danielle.mason@beasleyallen.com

Frank M. Petosa
Morgan & Morgan, P.A.
600 North Island Road, Ste. 400
Plantation, Florida 33324
Phone: (954) 318-0268
Fax: (954) 327-3018
Email: foetosa@forthepeople.com

Jason C. Webster
The Webster Law Firm
6200 Savoy Drive, Ste. 150
Houston, Texas 77036
Phone: (713) 396-5197
Fax: (713) 581-3907
Email: jwebster@thewebsterlawfirm.com

David S. Stellings
Lieff Cabraser Heimann & Bernstein, LLP
250 Hudson Street, 8th Floor
New York, New York 10013
Phone: (212) 355-9500
Fax: (212) 355-9592
Email: dstellings@lchb.com

The Court also appointed as Co-Lead Counsel, Christopher Seeger and Michael London, and as Liaison Counsel, James Cecchi. Together, and along with Ellen Relkin, Hunter Shkolnik, and Timothy O’Brien, they comprise the PSC Executive Committee. It is the Executive Committee’s duty to coordinate the responsibilities of the PSC, schedule PSC meetings, keep minutes or transcripts of these meetings, appear at periodic court noticed status conferences, perform other necessary administrative or logistic functions of the PSC.

The Invokana litigation involves allegations that Invokana causes diabetic ketoacidosis and kidney damage, and that defendant Janssen Pharmaceuticals, Inc., which developed and manufactured the drug, failed to adequately test the drug and warn of its risks.

The JPMDL declined to include other SLGT2 inhibitors in the litigation, such as Farxiga (dapagliflozin) and Jardiance (empagliflozin). Farxiga is marketed and distributed by AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca AB, AstraZeneca PLC, and Bristol-Myers Squibb Co., and Jardiance is marketed and distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, and Lilly USA, LLC.

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 sodium glucose cotransporter 2 (“SGLT2”) inhibitors.

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Philadelphia Judge Allows Invokana Case to Proceed Against Janssen

invokana-warning kidney-damageJanssen Pharmaceuticals Inc. lost a motion to dismiss a Texas man’s complaint that Invokana gave him diabetic ketoacidosis, allowing his product liability claim to proceed in the Philadelphia Court of Common Pleas.

Janssen, based in Raritan, New Jersey, filed a forum non conveniens motion, which Judge Denis Cohen denied. The company argued that:

  • Plaintiff Matthew Landes took Invokana and suffered his injury in Texas.
  • It would be difficult for Janssen to get witnesses like the plaintiff’s physician to come to Pennsylvania to testify.
  • Invokana was manufactured in Puerto Rico and developed in New Jersey.

In opposition, plaintiff attorneys Scott Levensten and Michael Johnston of the Levensten Law Firm PC in Philadelphia argued successfully that most of the discovery would come from Janssen’s offices in Pennsylvania or New Jersey. The case is Landes v. Janssen Research & Development LLC et al., case number 160300269, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.

Dozens of actions

Nearly 90 cases are pending against Janssen in Philadelphia courts. Invokana won approval from the Food & Drug Administration in 2013, but plaintiffs claim that it can cause a condition known as diabetic ketoacidosis, in which the body produces excess blood acids known as ketones.

Separately, dozens 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.

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

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

invokana-warning kidney-damageThe U.S. Food and Drug Administration (FDA) has strengthened 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, it has revised the warnings in the drug labels for these SGLT2 Inhibitors to include information about acute kidney injury and added recommendations to minimize this risk.

Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet. Patients should not stop taking their medicine without first talking to their health care professionals. Doing so can lead to uncontrolled blood sugar levels that can be harmful.

Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include:

  • Decreased blood volume
  • Chronic kidney insufficiency
  • Congestive heart failure
  • Taking other medications such as:
    • diuretics
    • blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors
    • angiotensin receptor blockers (ARBs)

Canagliflozin and dapagliflozin are prescription medicines used with diet and exercise to help lower blood sugar in adults with type 2 diabetes. They belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin and dapagliflozin lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.

101 cases of acute kidney injury

From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use. This number includes only reports submitted to FDA, so there are likely additional cases about which the FDA is unaware. In approximately half of the cases, the events of acute kidney injury occurred within 1 month of starting the drug, and most patients improved after stopping it. Some cases occurred in patients who were younger than 65 years. Some patients were dehydrated, had low blood pressure, or were taking other medicines that can affect the kidneys.

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.

Portnoff, of Beaumont, Texas, has taken the prescription drug Invokana, which is a member of the gliflozin class of pharmaceuticals, also known as sodium glucose co-transporter 2 (“SGLT2”) inhibitors. SGLT2 inhibitors inhibit renal glucose reabsorption through the SGLT2 receptor in the proximal renal tubules, causing glucose to be excreted through the urinary tract. This puts additional stress on the kidneys in patients already at risk for kidney disease.

While taking Invokana in Philadelphia, Pennsylvania, Portnoff developed diabetic ketoacidosis on or about February 20, 2015, as a result of treatment with Invokana, and was hospitalized at Hahnemann University Hospital in Philadelphia. As a result of his development of diabetic ketoacidosis, he  developed serious complications which required multiple days of hospitalization. Portnoff has endured pain and suffering, emotional distress, loss of enjoyment of life, and economic loss, including significant expenses for medical care and treatment which will continue in the future.

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FDA Confirms Acute Kidney Damage from Invokana, Invokamet and Farxiga

invokana-warning kidney-damageThe FDA has strengthened 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 has revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.

Canagliflozin and dapagliflozin are prescription medicines used with diet and exercise to help lower blood sugar in adults with type 2 diabetes.  They belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors.  Canagliflozin and dapagliflozin lower blood sugar by causing the kidneys to remove sugar from the body through the urine.

Since canagliflozin was approved in March 2013 to October 2015, the FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use.  This number includes only reports submitted to FDA, so there are likely additional cases about which the agency is  unaware.

The FDA recommends that healthcare professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin.  These include:

  • Decreased blood volume
  • Chronic kidney insufficiency
  • Congestive heart failure
  • Taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs).

Acute kidney injury is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body.  Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet.  Patients should not stop taking their medicine without first talking to their health care professionals.  Doing so can lead to uncontrolled blood sugar levels that can be harmful.  

Subscribers to Mass Tort Nexis can see original complaints filed in Invokana litigation in state and federal courts..

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FDA Warns that Invokana Causes Leg and Foot Amputations

Invokana Diabetic-KetoacidosisThe FDA is alerting the public about results of an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet).

It has not determined whether canagliflozin increases the risk of leg and foot amputations. FDA is currently investigating this new safety issue and will update the public when we have more information.

See the FDA Drug Safety Communication for additional details regarding the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial. Mass Tort Nexus has an overview of litigation involving Invokana.

Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

Defendants that manufactured Invokana are:

  • Janssen Research & Development
  • Johnson and Johnson
  • Janssen Pharmaceuticals,Inc.
  • Janssen Ortho
  • Mitsubishi Tanabe Pharma Corporation

Health care professionals should follow the recommendations in the canagliflozin drug labels. Monitor patients for the signs and symptoms described above and advise patients to seek medical advice if they experience them.

Patients should not stop or change their diabetes medicines without first talking to their health care professional. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canaglifozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.

According to a lawsuit filed in Georgia, defendants’ warning information for Invokana does not address the increased risk of diabetic ketoacidosis or kidney failure, merely stating that a “possible side effect” of Invokana is “kidney problems.”

Due to the defective nature of Invokana, patiends who were prescribed and ingested it, for even a brief period of time, were at increased risk for developing serious, and sometimes life-threatening, complications, including ketoacidosis.

Defendants withheld and concealed their knowledge that Invokana can cause serious, and sometimes life-threatening, complications, including diabetic ketoacidosis from the Plaintiff, other consumers, their physicians, the medical community at large and the general public.

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