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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Direct Filing of Invokana and Atrium C-Qur Lawsuits Now Permitted in Federal MDLs

In separate pretrial orders, the courts overseeing federal multidistrict litigation for Invokana and for Atrium C-Qur both ruled that plaintiffs may file their claims directly in the proceedings.

Direct filing eliminates delays involved in the transfer or removal of cases from other federal district courts.

Invokana MDL

The US Judicial Panel on Multidistrict Litigation (JPMDL) created the Invokana MDL on December 12, 2016. Plaintiffs charge that taking Invokana or Invokamet may result in patients suffering various injuries, including diabetic ketoacidosis and kidney damage. The actions thus implicate many common issues about the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs.

Direct filing does not stop the running of any statute of limitation or determine the choice of law. It does not constitute a waiver of Lexecon v. Milberg Weiss, 523 U.S. 26 (1998), which holds that MDL transferee judges lack authority to try cases that originated outside of the transferee court. Upon completion of pretrial proceedings to a directly-filed case, the court will transfer that case to the district court based on the district designated in the complaint.

Any attorney in good standing in any federal court is admitted pro hac vice in the litigation.

Atrium C-Qur mesh MDL

The JPMDL created the Atrium Medical Corp. C-Qur Mesh Products Liability MDL on December 8, 2016. The plaintiffs allege that defects in defendants’ C-Qur mesh products incite an allergic or inflammatory response that causes severe complications. All the actions involve factual questions about whether C-Qur mesh was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of C-Qur mesh to result in an allergic or inflammatory response, and whether defendants provided adequate instructions and warnings with the mesh.

Direct filing does not constitute a determination that venue is proper, has no impact on the choice of law including the statute of limitation.

Atrium is one of many hermia patch manufacturers facing lawsuits over making defective products. More hernia mesh MDLs may be created –  See MDL Motion Expected in Ethicon Physiomesh Hernia Repair Product Litigation.

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Judge Rules that Invokana Litigation Should Stay in Federal Court

invokana-warning kidney-damage
US District Judge Mitchell Goldberg ruled that the federal court will retain jurisdiction over 106 Invokana lawsuits that were filed last year in the Philadelphia Court of Common Pleas.

The ruling did not address whether the 106 cases will remain in US District Court for Eastern District of Pennsylvania or be rolled into MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in New Jersey.

Invokana is a prescription drug used to treat Type 2 Diabetes. Plaintiffs describe a variety of ailments, including kidney failure and diabetic ketoacidosis. The case is Arthur Portnoff v. Janssen Pharmaceuticals, Inc., Case No. 16-5955.

Class Action Fairness Act

Defendants removed all 106 cases to US District Court on Nov. 9, 2016, asserting federal jurisdiction as a “mass action” pursuant to the Class Action Fairness Act (“CAFA”). The plaintiffs contested removal and filed a motion to remand arguing that Defendants’ attempt to remove those cases was untimely, and that the federal Court lacked jurisdiction under CAFA.

To remove a mass action under CAFA, there must be 100 or more plaintiffs. The initial consolidation petition was filed on September 23, 2016, but was later withdrawn on October 11, 2016. On the same day, a second petition was filed.

The plaintiffs argued unsuccessfully that a 30-day time clock started running on Sept. 23. But Judge Goldberg ruled that the first petition was “legally inoperable.” The defendants filed within the time limit starting from the Oct. 11 petition.

The plaintiffs also argued that the Second Petition contemplated consolidation for pretrial proceedings only and that the single mention of a joint trial in the Second Petition’s conclusion was a “scrivener’s error.” Plaintiff’s counsel explained that she used a previously filed petition as a template for the Second Petition and that the proposal for a joint trial contained therein was a scrivener’s error.

However, 5 other plaintiff lawyers approved the document and failed to comment on the scrivener’s error, undermining their argument.

“So long as CAFA’s other jurisdictional requirements are met, federal district courts have jurisdiction over: any civil action . . . in which monetary relief claims of 100 or more persons are proposed to be tried jointly on the ground that the plaintiffs’ claims involve common questions of law or fact, except that jurisdiction shall exist only over those plaintiffs whose claims in a mass action satisfy the jurisdictional amount requirements . . . .,” the court said.

 

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New MDLs Requested for Farxiga, Mirena, Hip Implants and Sorin 3T Heater

farxiga320x320The US Judicial Panel on Multidistrict Litigation (JPMDL) will hear argument on March 30 on whether to create new multi-district litigation docket (MDL) No. 2776 for Farxiga and Xigudo diabetes medicines.

Oral argument is scheduled starting in the morning at the US Courthouse in Phoenix, Arizona. In addition, oral arguments will be held to create the following MDLs:

Ketoacidosis and kidney failure

Plaintiff’s attorney Holly Dolejsi of Robins Kaplan L.L.P. in Minneapolis moved to transfer currently filed Faxiga and Xigduo cases to either the Southern District of New York before Judge Lorna G. Schofield, the Eastern District of Pennsylvania before Judge Mitchell Goldberg, or the Southern District of Illinois before Judge Nancy J. Rosenstengel, who all have Farxiga cases assigned to them.

The motion involves 18 pending cases in 6 district courts, with 13 of the 18 filed in New York. The Defendants The Defendants in these cases are Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca AB, and AstraZeneca PLC.

As a result of ingesting Farxiga, the plaintiffs have suffered sudden onset of life-threatening diabetic ketoacidosis (often in the setting of normal blood glucose levels), and/or acute renal failure, and/or pyelonephritis (kidney infection) and/or urosepsis and continue to suffer from the sequelae of these injuries. Farxiga (dapagliflozin) is a pharmaceutical drug used to treat Type 2 Diabetes. All of these injuries were the subject of recent FDA safety advisories. On January 8, 2014, the FDA approved Farxiga for use in

On January 8, 2014, the FDA approved Farxiga for use in treatment of type 2 diabetics.2 Farxiga is a part of the gliflozin drug class. The gliflozin class is referred to generally as SGLT2 (short for “Sodium Glucose Cotransporter 2”) inhibitors. Xigduo XR was (dapagliflozin combined with metformin) designed and made by the same defendants as Farxiga, and is an extension of the Farxiga product line. Xigduo XR was approved shortly after Farxiga, on October 29, 2014.

FDA safety warning

On December 4, 2015 the FDA issued a safety communication disclosing they had found 73 adverse events reported between March 2013 and May 2015 that required hospitalization due to ketoacidosis-related to SGLT2 inhibitors. The FDA noted adverse event reports “include only reports submitted to FDA, so there are likely additional cases about which we are unaware.”

The same safety communication also warned of “life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis). In light of the data disclosed in the December 4, 2015 safety communication, the FDA changed the label for Farxiga and Xigduo XR to include a warning “about the risks of too much acid in the blood” and urged patients taking SGLT2 inhibitors to stop taking the drug and seek immediate medical attention if they have any symptoms of ketoacidosis. The FDA also required a label change to warn of urosepsis and pyelonephritis. On June 14, 2016, the FDA issued a safety announcement which advised that the existing warning about the risk of acute kidney injury on the Farxiga and Xigduo labels would be strengthened.

While a cross-motion to include Farxiga cases with Invokana MDL No. 2750 was raised, considered and ultimately denied by the Panel following the hearing in Charlotte, North Carolina, that request was opposed by both the Invokana Plaintiffs’ counsel and Defendants who claimed that the litigations were sufficiently different such that a joint SGLT2 MDL was improvident.

A total of 100 lawsuits have been filed in the MDL since the courts created it in December.

 

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Pharma and Med Device Companies Pay Doctors $2 Billion for “Consulting”

bribe doctor kickbackEven though it is illegal to pay kickbacks to doctors, pharmaceutical and medical device companies are paying $2 billion in general payments to 618,000 physicians each year, in addition to another $600 million a year to teaching hospitals, according to a ProPublica database.

General payments cover promotional speaking, consulting, meals, travel, gifts and royalties, but not research, as shown in its Dollars for Docs database.

The 10 drugs for which companies spent the most in payments to physicians in 2015 — many of which are targets of mass tort litigation —  were:

  1. Blood thinner Xarelto ($28.4 million).  In Re: Xarelto Products Liability Litigation in Philadelphia, hundreds of plaintiffs charge that the blood-thinning drug caused gastrointestinal bleeding, hemorrhagic strokes or death.
  2. Rheumatoid arthritis drug Humira ($24.9 million)
  3. Diabetes drug Invokana ($20.9 million). The Judicial Panel for Multidistrict Litigation (JPMDL) has created new MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in New Jersey.
  4. Hepatitis C drug Viekira ($19.2 million)
  5. Blood thinner Eliquis ($18.8 million). Bristol-Meyers Squibb Company and Pfizer Inc. have filed a motion to create new MDL No. 2757 in New York to hear Eliquis (Apixaban) products liability litigation.
  6. Diabetes drug Bydureon ($18.5 million)
  7. Testosterone drug Androgel ($15.3 million). US District Judge Matthew F. Kennelly has set June 5, 2017, for the start of first of six AbbVie bellwether trials in MDL 2545, in the Testosterone Replacement Therapy Products Liability Litigation in the Northern District of Illinois.
  8. Thyroid drug Synthroid ($14.7 million)
  9. Synthetic hormone Lupron ($14.3 million)
  10. Diabetes drug Victoza ($11.9 million).

“We’ve shown that physicians who receive payments from the industry tend to prescribe more brand-name drugs than those who don’t. Several academic studies later had similar findings. We also recently reported that companies continue to work with thousands of doctors who have received disciplinary sanctions against their licenses,” ProPublica states.

The disclosures included in Dollars for Docs were required under the Physician Payments Sunshine Act, a part of the 2010 Affordable Care Act.

For example, Janssen has paid $106 million to 141,294 doctors in connection with Xarelto, Invokana, Risperdal and many other drugs. From August 2013 to December 2015, Janssen paid:

Richard Aguilar
Internal Medicine
Huntington, CA
$345K
Gregory Mitchell
Specialist
Annapolis, MD
$290K
Bruce Bode
Endocrinology, Diabetes & Metabolism
Atlanta, GA
$286K

 

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New Mass Tort Dockets Created for Invokana and C-Qur mesh

invokana-warning kidney-damageThe Judicial Panel for Multidistrict Litigation (JPMDL) has created new:

Invokana Diabetes Drug

The Invokana litigation consists of 55 actions involving allegations that Invokana causes diabetic ketoacidosis and kidney damage, and that defendant Janssen Pharmaceuticals, Inc. (Janssen), which developed and manufactured the drug, failed to adequately test the drug and warn of its risks.

As requested by the plaintiffs, Judge Brian R. Martinotti of the District of New Jersey will supervise the MDL. Janssen is headquartered there, and many witnesses and relevant documents are likely to be found there. In addition, 37 of the constituent actions are pending in that district, as are multiple tag-along actions.

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 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

Atrium Medical c-qur surgical mesh
Atrium Medical C-Qur surgical mesh

C-Qur Hernia Mesh

Creation of the C-Qur mesh MDL was expected, see Parties Agree on New MDL for Atrium C-Qur Hernia Mesh. Judge Landya B. McCafferty in federal court in New Hampshire will oversee MDL 2753. Seven of the actions on the motion, as well as a number of state court cases, are pending in this district, and Atrium is headquartered there.

This litigation consists of thirteen actions pending in seven federal court districts, involving allegations that defects in defendants’ C-Qur mesh products incite an inflammatory response that promotes bowel adhesion formation, impedes proper abdominal wall fixation, and causes additional severe complications.

Judge Landya B. McCafferty in federal court in New Hampshire will oversee MDL 2753. Seven of the actions on the motion, as well as a number of state court cases, are pending in this district, and Atrium is headquartered there.

Atrium promotes the C-Qur line of surgical mesh products for permanent abdominal wall reinforcement in hernia surgeries, claiming that the C-Qur Mesh’s proprietary Omega-3 barrier coating reduces scar tissue formation between the mesh and the patient’s intestines (clinically known as “adhesions”) while promoting permanent fixation of the mesh to the abdominal wall.

 

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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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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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