Drug Injury Watch

New "Silent" Side Effect of Prilosec And Nexium: Chronic Kidney Disease (CKD), Without Any Prior Acute Kidney Injury

Most Of These Patients Did Not Experience Any Kidney Or Renal Problems Before Developing CKD Linked To PPI Heartburn Drugs Or Reflux Medicines

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

A recent medical study done by medical researchers in St. Louis, Missouri adds to the growing body of evidence which indicates that some popular heartburn drugs and acid reflux medicines like Prevacid, Prilosec, and Nexium can cause serious kidney-related side effects, including these conditions:

Acute Interstitial Nephritis (AIN)
Chronic Kidney Disease (CKD)
End-Stage Renal Disease (ESRD)
Severe Renal Impairment
Kidney / Renal Failure
Acute Kidney Injury

This newest study 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 at Washington University School of Medicine in St. Louis and the Veterans Affairs St. Louis Health Care System 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.

 

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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. Patients should be cautioned to tell their doctors if they're taking PPIs and only use the drugs when necessary."...

Over five years of follow up, the researchers found that more than 80 percent of PPI users did not develop acute kidney problems, which often are reversible and are characterized by too little urine leaving the body, fatigue and swelling in the legs and ankles.

However, more 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....

End-stage renal disease occurs when the kidneys can no longer effectively remove waste from the body. In such cases, dialysis or a kidney transplant is needed to keep patients alive.

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.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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February 2017 Label Changes For Sovaldi, Harvoni, And Other DAA Hepatitis C Drugs Are Made So As To Add A "Black-Box" Warning

Drug Safety Regulators Flag An Increased Risk Of Hepatitis B Virus Reactivation Which Can Result In Cases Of Fulminant Hepatitis, Liver Failure, And Death

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

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.

You can view the Prescribing Information for Sovaldi (accessed 2/16/17) to see how this new black-box, or bolded, warning appears on the drug label.

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. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and anti-HBc positive). HBV reactivation has also been reported in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV direct-acting antivirals may be increased in these patients.

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.

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Here is some background about this new drug safety development:

• In April 2016 we posted this article, "European Drug Regulators Consider Whether Harvoni, Sovaldi, And Other New "Hep-C" Drugs May Cause Liver Cancer Return, Hepatitis B Reactivation"; and,
• In October 2016 we posted this article, "Harvoni, Sovaldi, Viekira Pak, And Other Direct-Acting Antivirals Get Black-Box Warning: Risk Of Hepatitis B Virus Reactivation".

More recently, on December 1, 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 information:

Key Messages

• Direct-­acting antivirals (DAAs) are drugs authorized for sale in Canada to treat chronic hepatitis C virus (HCV) infection, a serious condition that can result in decreased liver function, serious scarring of the liver (cirrhosis) and liver cancer.
• 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).

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February 2017: Eliquis MDL Established For Federal Court Lawsuits; Placed In Southern District Of New York, With Judge Cote Presiding

For Eliquis Cases Filed In California State Court, JCCP Case Coordination Petition Is Still Pending, With Determination Expected In Next Couple Of Months

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

The Eliquis drug injury litigation is still at its beginning stages, with less than 100 lawsuits across the country having  been filed to date.

Eliquis (apixaban) was approved by the FDA in 2012. Pfizer and Bristol-Myers Squibb are the two drug companies responsible for Eliquis.

Eliquis does not have an antidote for a patient experiencing a trauma-induced bleeding event or needing emergency surgery.

These medical conditions may have been caused by the use of Eliquis:

• Serious Bleeding Events
• Irreversible Fatal Bleeding Events
• Trauma-induced Atypical Bleeding Incidents
• Gastrointestinal (GI) Bleeds
• Rectal Bleeding
• Hemorrhages
• Brain Hemorrhage
• Intracranial Hemorrhage
• Hemorrhagic Stroke
• Cardiac Bleeds

During the past year or so, an increasing number of Eliquis lawsuits have been filed involving people who had excessive bleeding, bled to death, or experienced other serious side effects of Eliquis.

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.

 

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From the February 7, 2017 JPML Order establishing this Eliquis federal court MDL we get this information about the litigation:

There are now a total of 53 actions pending in 17 districts raising substantially the same factual and legal issues concerning plaintiffs’ alleged injuries arising from Eliquis....

[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. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings on Daubert issues and other pretrial matters; and conserve the resources of the parties, their counsel and the judiciary.

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. Judge Denise L. Cote, who presides over all actions in the district, is an experienced transferee judge with the willingness and ability to manage this litigation. We are confident she will steer this litigation on a prudent course.   [footnotes omitted]

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.

Of course, we will continue to monitor the Eliquis lawsuits in the federal court MDL litigation as well as in the California state court system for significant developments, such as the anticipated Eliquis JCCP ruling, and report those here as we learn about them.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Multiple Sclerosis Drug Tecfidera: FDA Mandates January 2017 Label Change Which Adds Warnings About Liver Injury Cases

Besides Hepatotoxicity, Progressive Multifocal Leukoencephalopathy, Renal Toxicity, And Other Safety Issues Have Surfaced Since Clinical Trials

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Tecfidera (dimethyl fumarate) was approved by the FDA in 2013 as a treatment of patients with relapsing forms of multiple sclerosis (MS).

In February 2016 a rare but potentially fatal neurological disorder, progressive multifocal leukoencephalopathy (PML), was added to the Warnings and Precautions part of the Prescribing Information document, or drug label, for Tecfidera.

A more recent major change came in January 2017, with this one adding liver injury to the Warnings and Precautions part, as seen in the current Tecfidera drug label (accessed 2/7/17):

5.4      Liver Injury
Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment with TECFIDERA. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients....

From this January 25, 2017 article published by Reuters, "Possible liver injury added to label of Biogen MS drug", we get the news report about this new drug safety issue for Tecfidera:

The prescribing label for Biogen Inc's big-selling oral multiple sclerosis drug Tecfidera has been updated to include a warning of potential liver injury that could require hospitalization, the company said on Wednesday.

However, the updated label says signs of liver injury resolved when those patients stopped taking the medicine.

Tecfidera, the world's top-selling oral MS treatment, accounts for about a third of Biogen revenue. It had sales of $1.03 billion in the third quarter....

A Biogen spokeswoman said there have been 14 cases of liver injury reported out of some 230,000 patients treated with Tecfidera.

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We get additional 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.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)