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As can be seen from the following set of drug safety alerts, Pradaxa has caused significant concern among doctors and patients since soon after it first became available for use in the US.
In early December 2011 the FDA announced it would evaluate reports of bleeding in patients taking Pradaxa that have been submitted to the agency’s Adverse Events Reporting System (AERS) database to determine whether serious side effects are occurring at a higher rate than should be expected.
From the ISMP QuarterWatch 2011 Quarter 1 edition, which was published January 12, 2012, we get this summary of those adverse event reports to the FDA as regards the “substantial bleeding risks” associated with Pradaxa. In particular, gastrointestinal hemorrhages and hemorrhagic strokes were identified as some of these serious side effects in those elderly patients using Pradaxa.
The next Pradaxa safety “update” came from the ISMP QuarterWatch 2011 Quarter 2 edition, which was released April 5, 2012:
[Pradaxa], a new anticoagulant intended to reduce the risk of stroke, was a suspect drug in 856 reported cases, more than any other regularly monitored drug, but showed a decrease from 931 reports in the previous quarter. The new quarterly total included 117 reported patient deaths. With 511 reported cases of hemorrhage, and a median patient age of 80 years, these new bleeding reports reinforce our concern that vulnerable older patients may be receiving an overdose of this one-size-fits-all drug.
Due to these serious side effects, beginning in 2012 a growing number of personal injury and wrongful death Pradaxa lawsuits were filed against Boehringer Ingelheim Pharmaceuticals, Inc.
In August 2012 this federal court Pradaxa MDL, or case consolidation, was created: IN RE: PRADAXA (DABIGATRAN ETEXILATE) PRODUCTS LIABILITY LITIGATION, MDL No. 2385.
In May 2014, following several years of legal proceedings in the Pradaxa MDL, the defendant Boehringer Ingelheim agreed to settle most if not all of the approximately 4,000 filed Pradaxa lawsuits. This so-called “global-settlement” deal was reached just as the first federal court Pradaxa cases were set to go to trial in September 2014.
In May 2015 U.S. District Judge Herndon issued an Order which disbanded and ended the federal court Pradaxa MDL litigation he had presided over since August 2012. His reason for doing so: There were no active federal court Pradaxa lawsuits pending other than those which were part of the 2014 global settlement by Boehringer.
But at about the same time as Judge Herndon’s Order, there began to be a number of new Pradaxa lawsuits being filed in various state courts around the country. And this was the start of what has been referred to as a “round two” or the “second wave” of Pradaxa drug injury litigation.
The only difference, essentially, is that this round two or second wave of Pradaxa litigation is being pursued at the state court level.
The bottom line is this: If you experienced serious side effects from the use of Pradaxa, or a person died due to an adverse reaction while taking Pradaxa, you may still have a claim for legal compensation.
Invokana (canagliflozin) was approved by the FDA in 2013. Invokamet (canagliflozin and metformin) was approved by the FDA in 2014. Both of these drugs were approved for use by patients with Type 2 diabetes.
In December 2015 the FDA issued this Drug Safety Communication: “FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections”. In part, it warned about the risk of ketoacidosis, a serious medical condition caused by having too much acid in the blood, for Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors, a class of newer diabetes drugs which include Invokana and Invokamet.
In May and June 2016 the FDA announced it had strengthened the existing warning about the risk of acute kidney injury for Invokana and Invokamet.
In August 2016 the FDA sent letters to Janssen for Invokana and Invokamet label changes concerning fatal cases of ketoacidosis.
Due in part to these FDA drug safety alerts, there have been lawsuits filed on behalf of diabetes patients who used Invokana or Invokamet. Those lawsuits recently gave rise to a request for the consolidation of all Invokana and Invokamet cases pending in the various federal court districts around the country before one judge.
In September 2016, pursuant to 28 U.S.C. § 1407, a motion was filed to establish IN RE: INVOKANA (CANAGLIFLOZIN) PRODUCTS LIABILITY LITIGATION, MDL Docket No. 2750.
In October 2016 the attorneys for Defendant Janssen Pharmaceuticals, Inc. (“Janssen”) indicated, in their legal document filed as a response to this MDL motion, it agreed that all Invokana cases filed in the federal court system should be consolidated. Further, they agreed that federal Judge Brian Martinotti, of the District of New Jersey, would be an appropriate choice by the Judicial Panel for Multidistrict Litigation (JPML) for the so-called “transferee judge” presiding over this Invokana MDL.
In December 2016 the JPML issued an Order establishing this consolidation of all Invokana and Invokamet federal court lawsuits.
We are currently investigating possible Invokamet and Invokana lawsuits against the drug company Janssen for diabetes patients who have developed any of the medical conditions listed above.
Of course, we will continue to monitor the Invokana / Invokamet legal cases and report significant developments here.
There have been drug injury lawsuits filed involving Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin and metformin extended-release), which are relatively new diabetes medicines in the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors class of drugs.
Those lawsuits recently gave rise to a request for the consolidation of all Farxiga and Xigduo XR cases pending in the various federal court districts around the country before one judge. This legal motion is scheduled to be heard by United States Judicial Panel On Multidistrict Litigation (JPML) on March 30, 2017.
From this court document we get the following information about this proposed federal court multidistrict litigation, or MDL, for Farxiga and Xigduo XR:
This motion for transfer involves eighteen pending cases in six district courts asserting similar claims….
Each of these Actions arise from the same or similar operative facts and wrongful conduct alleging that, as a result of ingesting Farxiga, 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….
… Judge [Lorna G.] Schofield in the Southern District of New York is already presiding over the vast majority of the Farxiga cases filed nationally. She has already conducted a pretrial conference to attempt to coordinate the cases pending before her. Continuing with that process would prevent any further delay in those cases. Further, Defendant Bristol-Myers Squibb has its principal place of business in New York….
If the Panel should decide that transfer to the Southern District of New York is not warranted, Plaintiff requests in the alternative, Transfer to either the Eastern District of Pennsylvania before Judge Mitchell Goldberg, or the Southern District of Illinois before Judge Nancy J. Rosenstengel.
Be assured we will be watching for the JPML determination about whether or not to establish this Farxiga / Xigduo XR MDL.
A recent medical study done by medical researchers in St. Louis, Missouri indicates that more than half of those patients who develop chronic kidney damage (CKD) while using proton pump inhibitors (PPIs) heartburn drugs and acid reflux medicines do not experience acute kidney problems before their CKD diagnosis.
These researchers published their findings in this February 2107 article, “Long-term kidney outcomes among users of proton pump inhibitors without intervening acute kidney injury”, published in the Kidney International medical journal.
A February 22, 2017 ScienceDaily news report, “Popular heartburn drugs linked to gradual yet ‘silent’ kidney damage”, provides a good analysis of this recent safety study concerning Nexium, Prevacid, Prilosec, and other PPI heartburn drugs and acid reflux medicines.
From that ScienceDaily news report we get this information:
The onset of acute kidney problems is not a reliable warning sign for clinicians to detect a decline in kidney function among patients taking proton pump inhibitors, said Ziyad Al-Aly, MD, the study’s senior author and an assistant professor of medicine at Washington University School of Medicine. “Our results indicate kidney problems can develop silently and gradually over time, eroding kidney function and leading to long-term kidney damage or even renal failure…. [M]ore than half of the cases of chronic kidney damage and end-stage renal disease associated with PPI use occurred in people without acute kidney problems….
We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for people who have developed any of the kidney-related medical problems listed above.
Of course, we will continue to monitor the medical literature for developments concerning serious kidney-related side effects of popular heartburn drugs and acid reflux medicines like Nexium, Prilosec, and Prevacid.
In February 2017 a so-called “black-box” warning was added to the drug labels for Harvoni, Sovaldi, Technivie, Viekira Pak, and other direct-acting antivirals, warning doctors and patients that cases of hepatitis B virus (HBV) reactivation have been reported. Further, it states that some of those cases resulted in fulminant hepatitis, hepatic failure, and death.
For more details, we get the following from the Warnings and Precautions part of the February 2017 revised Sovaldi drug label:
5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death….
HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection, reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, i.e., increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur.
Back in December 2016 Health Canada issued this document, “Summary Safety Review — Direct-acting antivirals – Assessing the Potential Risk of Hepatitis B Virus Reactivation”, from which we get the following key points:
- Health Canada carried out a review of the potential risk of hepatitis B virus (HBV) reactivation with the use of DAAs. The review was triggered by reports that patients infected with both HBV and HCV may experience a reactivation of their HBV infection if DAAs are used to treat their HCV infection. These reports were identified by the European Medicines Agency (EMA).
- Health Canada’s review concluded that there is a potential risk of HBV reactivation in patients coinfected with both HBV and HCV, and the use of DAAs. Health Canada has recommended that the safety information for all DAAs be updated to inform about this potential risk.
We will continue to monitor this aspect of the safety profile of Harvoni, Sovaldi, Technivie, Viekira Pak, and other direct-acting antivirals (DAAs) used increasingly in the US and elsewhere to treat the hepatitis C virus (HCV).
In the federal court system, there are now more than 50 Eliquis lawsuits filed, and more of these drug injury and death cases are expected. Given this situation, in early February 2017 the United States Judicial Panel on Multidistrict Litigation (JPML) established this consolidation of all federal court Eliquis cases, IN RE: ELIQUIS (APIXABAN) PRODUCTS LIABILITY LITIGATION — MDL No. 2754.
From the February 7, 2017 JPML Order establishing this Eliquis federal court MDL we get this information about the litigation:
[W]e find that these actions involve common questions of fact, and that centralization will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. All the actions share common factual questions arising out of allegations that plaintiffs suffered severe bleeding and related injuries as a result of taking Eliquis (apixaban), that defendants did not conduct sufficient testing of the drug, and that defendants’ warnings and instructions as to the alleged risks, including the unavailability of a reversal agent to counteract bleeding, were inadequate. Issues concerning the design, testing, manufacture, regulatory approval, labeling, and marketing of Eliquis thus are common to all actions….
We conclude that the Southern District of New York is an appropriate transferee district for this litigation. Common defendants BMS and Pfizer both have their corporate headquarters within the district, and therefore relevant documents and witnesses are likely to be located there. Sixteen actions on the motion and three potential tag-along actions are pending there.
In addition to the federal court Eliquis cases, there are a significant number of Eliquis lawsuits filed in the California state court system. As a result, a petition to coordinate those California Eliquis cases was submitted to the Chair of the Judicial Council seeking to establish a consolidation, there, which would be similar to the federal court Eliquis MDL.
In California, if that petition to coordinate the Eliquis lawsuits — which was submitted to the Chair of the Judicial Council (the Chief Justice) and then assigned to a motion judge for determination — is granted, its result would be called the California Eliquis JCCP (Judicial Council Coordination Proceedings).
It is currently expected that the determination about the creation of this California Eliquis JCCP will be made in the next couple of months.
In January 2017 liver injury was added to the Warnings and Precautions part of the Prescribing Information document, or drug label, for Tecfidera (dimethyl fumarate), which was approved by the FDA in 2013 as a treatment of patients with relapsing forms of multiple sclerosis (MS).
We get background information and some commentary from this February 1, 2017 Medscape Medical News article, “Dimethyl Fumarate for MS: Liver Injury Warning Strengthened”:
The prescribing information for the oral multiple sclerosis (MS) medication dimethyl fumarate (Tecfidera, Biogen) has been updated to include a warning of potential liver injury that could require hospitalization.
The new information notes that clinically significant cases of liver injury have been reported in patients treated with the drug in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment….
MS experts contacted by Medscape Medical News did not think the labeling change would make much difference to its use.
“The incidence of liver function abnormalities appears to be rare, but the new labeling informs prescribers that monitoring will be necessary,” said Edward Fox, MD, MS Clinic of Central Texas, Round Rock. “I would expect that this will lead to more frequent laboratory testing early in the course of treatment, but would be very unlikely to affect prescribing patterns. Personally, it won’t change what I have already been doing. Most disease-modifying treatments for MS, including all approved oral therapies, have labeling reflecting a risk of hepatic injury.”…
But Mark S. Freedman, MD, Ottawa Hospital, Ontario, Canada, noted that this was another side effect to have shown up with the drug since it reached the market.
“Tecfidera is not the ‘honey’ it was reported to be from the clinical trials,” he commented. “Progressive multifocal leukoencephalopathy and other opportunistic infections (herpes), hepatotoxicity, renal toxicity, and other issues have all surfaced since the trials were reported.”
We will continue to monitor the medical literature and adverse event reports for significant cases of liver injury associated with the use of Tecfidera by MS patients.
A new Institute for Safe Medication Practices (ISMP) report, “New Safety Issues for Hepatitis C Antivirals”, appeared in the “ISMP QuarterWatch: January 25, 2017 — New data from 2016 Q2″ publication.
Here are some of the details from the full report on this recent ISMP research project which examined Harvoni, Sovaldi, and other hepatitis C medicines in the direct-acting antivirals (DAAs) class of drugs:
… [W]e searched the most recent 12 months of FAERS data for acute liver failure cases associated with these new drugs. Acute liver failure is a rare, dramatic, and catastrophic medical emergency that involves sudden damage to so much liver tissue that continued survival is at risk. While most organs are ultimately affected, one critical symptom is encephalopathy–a brain dysfunction that can involve psychiatric disturbances, motor problems, hyperventilation, and even coma…. [footnote omitted]
For the 12 months ending June 30, 2016, we identified 524 reported cases worldwide of liver failure in which one of the nine direct-acting antivirals was a primary or secondary suspect drug…. The 524 liver failure cases occurred more frequently in males (55%) and in patients with a median age of 61 years. In these reports, 165 cases (31.5%) had an outcome of death at the time the report was submitted. Overall, 90% of the reports were originated by health professionals, including 34 cases extracted from the medical literature with duplicate references excluded. Table 4 shows 55 cases involved liver transplants, but it was not clear whether the transplants were a treatment for liver failure, or whether the event might have occurred in a post-transplant population. These cases reflect the global reported adverse event experience, with 386 (73.7%) from outside the U.S.
And from the Executive Summary section of this January 2017 ISMP QuarterWatch publication, we get these additional facts about the liver failure cases associated with Sovaldi, Harvoni, and other “Hep C” DAAs:
The 524 reported cases of liver failure included all the approved direct-acting antivirals as either primary or secondary suspect drugs, often in combination with each other or with ribavirin. Almost half the cases also included the hallmark symptom of liver failure, encephalopathy, which is a form of brain injury resulting in delirium, personality changes, suicidal behavior, sleep-wake reversal, and coma. Overall, 165 (31.5%) had died at the time of the report. While it was challenging to separate cases to which complications of hepatitis C might have contributed, 90% of the cases were submitted by healthcare professionals, who would be likely to understand the natural progression of the disease.
We will continue to monitor this new drug safety issue and are interested in hearing from or about any hepatitis C patients treated with Sovaldi or Harvoni who developed liver failure or were diagnosed liver injury, which might have been caused by these drugs.
Here is overview of this rather significant and substantial November 2016 Iclusig Prescribing Information revision which was mandated by the FDA.
In the Boxed Warning section of the Iclusig drug label there was some additional safety information put in the pre-existing parts about (1) various types of arterial occlusions and (2) heart failure. Also, there is a new part entitled Venous Thromboembolism which addresses venous occlusive events.
Under the Warnings and Precautions section of the Iclusig drug label there were some additional facts and new information put in the following pre-existing parts, which are presented the order in which they were set forth on the FDA CDER SLC page for Iclusig:
5.1 Arterial Occlusion
5.11 Fluid Retention
5.12 Cardiac Arrhythmias
5.14 Tumor Lysis Syndrome
5.17 Embryo-Fetal Toxicity
5.2 Venous Thromboembolism
5.3 Heart Failure
5.9 Ocular Toxicity
Further, under Warnings and Precaution, there is this new part: 5.15 Reversible Posterior Leukoencephalopathy Syndrome (RPLS).
Iclusig (ponatinib) is a kinase inhibitor approved by the FDA as a treatment for certain types of leukemia in adult patients.
Finally as regards this limited Iclusig label changes overview, under the Adverse Reactions section of the Iclusig drug label there was some additional facts and new information put in this pre- existing part, 6.1 Clinical Trial Experience.
The complete set of new side effects warnings can be seen on the FDA’s Drug Safety Labeling Changes (SLC) page for Iclusig.
We will continue to monitor the safety profile of the leukemia drug Iclusig and to report significant future developments.
As regards the liver cancer risks that have been mentioned in connection with the hepatitis C drugs Sovaldi and Harvoni, during the past nine months there have been mixed messages about whether there is an apparent side-effect situation or not.
We start our update on this still emerging drug safety issue with this April 2016 Medscape news report, “Liver Cancer Found in Hepatitis C Patients on New Antivirals”, from which we get this excerpt:
In a surprising number of patients with hepatitis C and cirrhosis, hepatocellular carcinoma develops within weeks of starting treatment with direct-acting antivirals, new research suggests.
“I do not think that direct-acting antivirals are directly responsible,” said lead investigator Stefano Brillanti, MD, from the University of Bologna, Italy.
“The hypothesis is that immune surveillance may be reduced too rapidly,” he told Medscape Medical News. “You have an immediate drop in viremia, but also attenuation of inflammation. I think inflammation is a bad thing in terms of hepatitis progression, but it may be a good thing in terms of controlling cancer.”
Then we move forward to this November 2016 article published by PracticeUpdate as part of their Gastroenterology section, “Direct-Acting Antiviral Medications for Hepatitis C Virus Infection Do Not Raise Cancer Risk”, from which we get this more recent information:
Patients with hepatitis C who take direct-acting antiviral medications have been found to be at no higher risk of developing liver cancer than those who do not take the medication. If they do develop liver cancer, however, they might be at an increased risk of more aggressive, infiltrative patterns of cancer.
This finding of a retrospective database study was reported at The Liver Meeting 2016, from November 11 – 15.
Alfredo Alberti, MD, of the University of Padova, Italy, explained, “Data on clinical outcomes in cirrhotic patients with hepatitis C treated with direct-acting antiviral agents are still scanty and controversial. This is the case concerning the development of a liver cancer, one of the most frequent and deadly complications of hepatitis C virus infection.”
We will continue to monitor the medical literature and watch for any drug regulatory agency action concerning the possible association between direct-acting antiviral hepatitis C drugs like Sovaldi and Harvoni with liver cancer diagnoses, be it the initial incidence or a recurrence of the hepatocellular carcinoma.
We continue to monitor the drug safety regulators as well as the medical literature concerning the possible link between an increased risk of these amputations and the use of SGLT2 inhibitors such as Invokana, Invokamet, Farxiga, Xigduo XR, and Jardiance.
From the Health Product InfoWatch newsletter — formerly The Canadian Adverse Reaction Newsletter (CARN) — put out by Health Canada in December 2016, under the “Product monograph updates” heading, we get this drug safety development:
Invokana (canagliflozin) and Invokamet (canagliflozin and metformin hydrochloride)
The risk of lower limb amputation, primarily of the toe, has been added to the Adverse Reactions section of the Canadian product monographs for Invokana (canagliflozin) and Invokamet (canagliflozin and metformin hydrochloride).
As background, from this July 2016 Medscape Medical News report, “EMA Extends Amputation Investigation to All SGLT2 Inhibitors” (free registration required to access article):
The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has extended the scope of its investigation into the possible link between the sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin (Invokana, Vokanamet, Janssen) and amputations to include other drugs of the same class.
Now, the PRAC’s review will include the other SGLT2 inhibitor medicines dapagliflozin (Farxiga, Xigduo XR, AstraZeneca), and empagliflozin (Jardiance, Boehringer Ingelheim), based on the determination that the potential risk may be relevant for them as well.
And back in mid-May 2016 there was this item, “FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate”.
Since then, we have not heard again from the FDA about the results of this investigation regarding leg, foot, and toe amputations possibly caused by the use of Invokana and Invokamet.
All content by attorney Tom Lamb