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Uloric-Related Acute Kidney Injury And Acute Renal Failure Pointed Out In Safety Study

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According to a recent medical journal article, acute renal failure (ARF), or kidney failure, is reported as an adverse drug reaction 5.7 times more frequently with Uloric (febuxostat) than with other urate-lowering therapy (ULT) gout drugs, and 3.3 times more often with allopurinol. This is some important new Uloric drug safety information from our perspective.

This article, “Acute Kidney Injury Associated With Febuxostat and Allopurinol — A Post-Marketing Study”, was published by the Arthritis Research & Therapy medical journal in November 2019. The new Uloric drug safety information in that article is summarized in this excerpt:

In the present study, we detected a disproportionality signal for [acute renal failure (ARF)] and the ULTs [Uloric (febuxostat)] and allopurinol. The presence of this signal was confirmed in a variety of sensitivity analyses (i.e., when [Uloric (febuxostat)] and allopurinol were the only suspected drugs, when we used other [Xanthine oxydase (XO)] inhibitors as the comparator or when known nephrotoxic drugs were excluded).

…. Until the present case/non-case study, the risk of [acute kidney injury (AKI)] associated with allopurinol and [Uloric (febuxostat)] had been underestimated.

We will continue to monitor the FDA and review medical journals for any significant developments concerning this new Uloric drug safety information about acute kidney injury (AKI) and acute renal failure (ARF).

Our law firm is investigating possible Uloric lawsuits where patients have suffered Uloric side effects.

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Prilosec / Prevacid / Nexium Federal Court MDL For Kidney Injury Cases

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In August 2017 the United States Judicial Panel on Multidistrict Litigation (JPML) granted a second motion for centralization or consolidation of federal court lawsuits brought by plaintiffs in proton-pump inhibitors (PPIs) cases alleging kidney injury.

In more detail, the JPML established IN RE: PROTON-PUMP INHIBITOR PRODUCTS LIABILITY LITIGATION (NO. II) – MDL No. 2789. From the JPML’s Transfer Order filed on August 2, 2017 we get these details:

In the complaints in these 161 personal injury and wrongful death actions, plaintiffs allege that as a result of taking one or more proton-pump inhibitors (PPIs), they or their decedents suffered kidney injury (e.g., chronic kidney disease (CKD), acute interstitial nephritis, end stage renal disease, or kidney failure). Plaintiffs allege that defendants failed to adequately warn of the negative effects and risks associated with PPIs….

Notably, during this second time around only one drug company, Takeda. was still opposed to the creation of any PPIs federal court MDL. But the JPML was not convinced by Takeda’s various arguments in opposition, as seen from this excerpt from the Transfer Order:

And, although it is true that AstraZeneca is sued in far more actions than Takeda, a significant number of actions are “mixed use” cases in which the plaintiffs allege use of more than one PPI, and sue Takeda and one or more other PPI manufacturers, including AstraZeneca. The prospect of additional cases against Takeda does not seem far-fetched [10]. Given these circumstances, including the seemingly indivisible nature of plaintiffs’ alleged injuries in the “mixed use” cases, we decline to carve out from the MDL cases or claims against Takeda. [footnotes omitted]

Lastly, this point – which may have been a factor for the JPML when ruling this time on the Prilosec / Prevacid / Nexium federal court MDL consolidation – was mentioned in a footnote for the August 2017 Transfer Order: “The variety of alleged kidney injuries arguably has diminished, as most plaintiffs allege that they suffer from [chronic kidney disease (CKD)]….”

We continue to monitor legal and medical developments regarding the drug injury aspects of Nexium, Prevacid, and Prilosec.

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Federal Court Invokana MDL In New Jersey With Judge Brian Martinotti

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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.

[Read this article in full at original source]

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New Federal Court Multidistrict Litigation (MDL) For Farxiga Lawsuits

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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.

[Read this article in full at original source]

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Invokana / Farxiga / Jardiance

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Prevacid, Nexium, And Prilosec Linked To Risk Of Chronic Kidney Damage

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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.

[Read this article in full at original source]

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Warnings About Significant Liver Injury Added To Tecfidera Drug Label

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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.

[Read this article in full at original source]

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December 2016: FDA Requires Safety Warnings Label Change For Jardiance

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After the December 2, 2016 decision by the FDA to expand the health benefits for the relatively new diabetes medicine Jardiance (empagliflozin) to include preventing fatal heart attacks and strokes in type 2 diabetes patients, we saw news reports about its expected effect on Jardiance sales in the U.S.

From this December 9, 2016 Reuters article, “New diabetes guidelines imminent, Jardiance sales may surge”, we get this information:

Two leading U.S. medical societies are poised in the coming weeks to issue new diabetes treatment guidelines reflecting the lifesaving cardiovascular effects of Eli Lilly’s Jardiance in a move expected to drive up the drug’s sales.

The forthcoming guidelines from the American Diabetes Association and the American Association of Clinical Endocrinologists….

[Ashtyn Evans, an analyst with the Edward Jones investment company,] predicted that doctors would now favor Jardiance for new patients over other similar drugs called SGLT-2 inhibitors, including Johnson & Johnson’s Invokana and AstraZeneca’s Farxiga, until they complete their own heart-protection studies in the next two years.

What did not get this same type of media coverage was the other part of the FDA’s December determination, a “Revised: December 2016” Jardiance Prescribing Information document — also called the package insert or drug label — which contains increased warnings about some serious side effects.

From that new Jardiance drug label (accessed 12/12/2016), at “5 Warnings and Precautions”, we get this updated safety information:

5.2 Ketoacidosis

Fatal cases of ketoacidosis have been reported in patients taking JARDIANCE.

5.3 Acute Kidney Injury and Impairment in Renal Function

JARDIANCE causes intravascular volume contraction and can cause renal impairment. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving SGLT2 inhibitors, including JARDIANCE; some reports involved patients younger than 65 years of age.

We point out that similar drug safety information was added back in August 2016 to the drug label for Invokana (canagliflozin), another diabetes medicine in the SGLT-2 inhibitors class of drugs.

Of course, we will continue to watch for reports of Jardiance adverse drug reactions (ADRs) made to the FDA or included in future medical journal articles.

[Read this article in full at original source]

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Long-Term Use Of Prevacid, Prilosec, and Nexium May Lead To Strokes

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In November 2016 we learned about a new study that suggests these popular category heartburn medications, known as proton pump inhibitors (PPIs), may increase the risk of ischemic strokes.

From a press release from the American Heart Association, “Popular heartburn medication may increase ischemic stroke risk”, we get the following facts:

A popular group of antacids known as proton pump inhibitors, or PPIs, used to reduce stomach acid and treat heartburn may increase the risk of ischemic stroke, according to preliminary research presented at the American Heart Association’s Scientific Sessions 2016….

Ischemic stroke, the most common type of stroke, is caused by clots blocking blood flow to or in the brain.

… Researchers determined if the stroke occurred while patients were using 1 of 4 PPIs: omeprazole (Prilosec), pantoprazole (Protonix), lansoprazole (Prevacid) and esomeprazole (Nexium).

For ischemic stroke, researchers found:

Overall stroke risk increased by 21 percent when patients were taking a PPI.

At the lowest doses of the PPIs, there was slight or no increased stroke risk.

At the highest dose for these 4 PPI’s, stroke risk increased from 30 percent for lansoprazole (Prevacid) to 94 percent for pantoprazole (Protonix).

We will continue to monitor the various side effects that have been associated with the use of Nexium, Prilosec, and Prevacid, as well as proton pump inhibitors (PPIs) heartburn drugs and acid reflux medicines.

[Read this article in full at original source]

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Viagra, Nexium, And Invokana: Drug Injury Lawsuits Report: Summer 2016

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We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for patients who used the drugs listed below and developed certain side effects.

(1) Erectile Dysfunction (ED) Pills, Benign Prostatic Hyperplasia (BPH) Medicines, and Pulmonary Arterial Hypertension (PAH) Medications in the Phosphodiesterase 5 (PDE-5) Inhibitors Class of Drugs

Adcirca (tadalafil) — Eli Lilly and Company
Cialis (tadalafil) — Eli Lilly and Company
Levitra (vardenafil hydrochloride) — GlaxoSmithKline
Revatio (sildenafil citrate) — Pfizer
Staxyn (vardenafil hydrochloride) — GlaxoSmithKline
Stendra (avanafil) — Vivus and Auxilium Pharmaceuticals
Viagra (sildenafil citrate) — Pfizer

These various prescription drug products have been linked to malignant melanoma skin cancer (but not basal or squamous cell skin cancers).

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(2) Heartburn Medicines and Acid Reflux Pills like Prevacid, Prilosec, and Nexium in the Proton Pump Inhibitors (PPIs) Class of Drugs

Nexium (esomeprazole magnesium) [prescription drug] == AstraZeneca LP
Nexium 24HR (esomeprazole magnesium) [over-the-counter] — Pfizer Consumer Healthcare
Prilosec (omeprazole) [prescription drug] — AstraZeneca LP
Prilosec OTC (omeprazole) [over-the-counter] — Procter & Gamble Manufacturing Co.
Prevacid (lansoprazole) [prescription drug] — Takeda Pharmaceuticals America, Inc.
Prevacid 24 HR (lansoprazole) [over-the-counter] — Novartis Consumer Health, Inc.

The use of these proton pump inhibitors (PPIs) can result in an increased risk of developing Acute Interstitial Nephritis (AIN) as well as other types of kidney disease and kidney injury.

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(3) Diabetes Medicines in the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors Class of Drugs

Invokana (canagliflozin) — Janssen Pharmaceuticals
Invokamet (canagliflozin and metformin) — Janssen Pharmaceuticals
Farxiga (dapagliflozin) — AstraZeneca Pharmaceuticals
Xigduo XR (dapagliflozin and metformin extended-release) — AstraZeneca Pharmaceuticals
Jardiance (empagliflozin) — Boehringer Ingelheim Pharmaceuticals
Glyxambi (empagliflozin and linagliptin) — Boehringer Ingelheim Pharmaceuticals
Synjardy (empagliflozin and metformin hydrochloride) — Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company

These drug injury lawsuits primarily involve the side effects ketoacidosis, kidney problems, and severe infections.

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These three types of drug injury cases are starting to gain some momentum in terms of the number of lawsuits filed against the responsible pharmaceutical companies in courts across the country.

We have been representing patients and their family in drug injury lawsuits for the past 16 years and this is our main practice area. Let us know if we can help you.

[Read this article in full at original source]

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Viagra / Cialis / Levitra
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Nexium / Prevacid / Prilosec

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Invokana / Farxiga / Jardiance

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Invokana / Farxiga / Jardiance: UTIs Then Urosepsis And Pyelonephritis

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To date, most attention has been directed to the association between the sodium-glucose cotransporter-2 (SGLT2) inhibitors drugs and diabetic ketoacidosis (DKA).

More recently, there was an FDA announcement concerning a label change about the acute kidney injury side effect.

What has received less attention, it seems, is the fact that these still relatively new diabetes drugs — Invokana, Farxiga, and Jardiance, as well as their several “combination” products — have been linked to serious urinary tract infections (UTIs) that can result in more severe conditions, such as urosepsis and pyelonephritis.

For presenting some of the leading information about these side effects we turn to this source, “FDA 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”, issued on December 4, 2015.

From the “Safety Announcement” part of that document we get an introduction to this set of safety problems for Invokana, Farxiga, and Jardiance:

… symptoms of a urinary tract infection, such as a feeling of burning when urinating or the need to urinate often or right away; pain in the lower part of the stomach area or pelvis; fever; or blood in the urine. Contact a health care professional if you experience any of these symptoms….

We also identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported to FAERS from March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.

And for the purpose of going more in-depth about the apparent increased risk of serious urinary tract infections (UTIs) associated with these SGLT2 inhibitor diabetes drugs, we get the following details from the “Data Summary” section of this December 2015 ‘FDA Drug Safety Communication:

A search of FAERS from March 2013 through October 2014 identified 19 cases of urosepsis reported with the SGLT2 inhibitors [Invokana (canagliflozin)] [n=10] and [Farxiga (dapagliflozin)] [n=9]). All cases resulted in hospitalization. No deaths were reported. Four patients required admission to the intensive care unit, and two required hemodialysis to treat renal failure. The median time to onset was 45 days (range 2 to 270 days). Discontinuation of the SGLT2 inhibitor was reported in 15 cases.

We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for diabetes patients using SGLT2 inhibitor diabetes drugs who have developed side effects such as diabetic ketoacidosis, acute kidney injury, and serious urinary tract infections (UTIs) that led to urosepsis or pyelonephritis

[Read this article in full at original source]

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