Drug Safety Developments

Nexium / Prilosec / Prevacid Series: Why Weren't We Warned Sooner?

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

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Series Overview:

Article 1 – Overview and Background
Article 2 – The Devastating Side Effects
Article 3 – Why Weren’t We Warned Sooner?
Article 4 – Factors for Drug-Injury Lawsuits

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In the first article of the Nexium, Prevacid, Prilosec Series, I gave a brief overview of some of the possible side effects of these PPI drugs.  

The second article of this series provides more detailed information about these devastating side effects.

In this article, I will provide a timeline of what was known about the relationship between possible kidney injuries and Nexium, Prilosec, and Prevacid use.

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1992	According to the article, Acute interstitial nephritis due to proton pump inhibitors, "Ruffenach et al., published the first case report of AIN due to omeprazole in 1992" in the article titled "Acute Interstitial Nephritis Due to Omeprazole."
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1997	A study titled "Acute interstitial nephritis secondary to omeprazole" states that "Acute interstitial nephritis is thus a rare complication of the proton pump inhibitor omeprazole. In elderly patients with renal failure and sterile pyuria, consideration should be given to this unusual adverse event and, along with exclusion of other causes, the drug ceased."
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2004	In the study "Drug-induced tubulo-interstitial nephritis secondary to proton pump inhibitors...," it is established that the "drugs most commonly associated with interstitial nephritis were the proton pump inhibitors omeprazole and lansoprazole."
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2006	The study "Proton Pump Inhibitors and Acute Interstitial Nephritis" states that "there have been case reports and a recent case series implicating [PPIs] in acute interstitial nephritis (AIN) and progression to acute renal failure (ARF)."
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2007	According to the study "Proton pump inhibitors and the kidney: critical review," there is an "ever increasing number of cases of acute interstitial nephritis (AIN) associated with PPI therapy...[and] all PPIs have been documented to cause AIN."  This article also stated that "Several adverse drug event registries now note PPIs as the most common cause of drug-induced AIN."
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2013	The study "Proton pump inhibitors and acute kidney injury: a nested case-control study" provides the alarming statistic that "Patients with a renal disease diagnosis were twice as likely to have used a previous prescription for a PPI."
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2014	In December of 2014, the FDA finally released a revised drug label that finally included a warning that "Acute interstitial nephritis has been observed in patients taking PPIs."

 

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These are only some of the studies published in the 22 years before the FDA released a revised drug label.

In light of all this research, and the widespread use of Nexium, Prilosec, and Prevacid, one has to wonder:

• Why wasn't the public warned sooner about the possibility of such devastating kidney damage?  
• What were the drug manufacturers waiting for before going to the FDA with a label revision?
• Were the drug manufacturers putting their own financial gain before the physical well-being of the people they're supposed to be helping?
• How many people suffered needlessly during those 22 years while the drug manufacturers seemingly did nothing?

Only the FDA, AstraZeneca Pharmaceuticals, Takeda Pharmaceuticals America, Inc., and the other responsible drug manufacturers know the answers to these questions.

However, what is undeniable is that the drug manufacturers must be held responsible for the people who are suffering from AIN and other kidney damage after using Nexium, Prilosec, and Prevacid.

We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for people who have developed specific kidney-related medical problems after using Nexium, Prilosec, or Prevacid.  My next and final article in this series will discuss the specific criteria for these cases.  In the meantime, please feel free to contact us, and see our website for more information on cases concerning Nexium, Prilosec, and Prevacid.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

Nexium / Prevacid / Prilosec Series: The Devastating Side Effects

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

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Series Overview:

Article 1 – Overview and Background
Article 2 – The Devastating Side Effects
Article 3 – Why Weren’t We Warned Sooner?
Article 4 – Factors for Drug-Injury Lawsuits

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In the first article of the Nexium, Prevacid, Prilosec Series, I gave a brief overview of some of the possible side effects of these PPI drugs.  I will now expand on this previous discussion to provide more detailed information about these conditions.  Please know that I am not qualified to give medical advice, and am simply summarizing recent studies concerning the possible side effects of Nexium, Prilosec, and Prevacid.

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1. Acute Interstitial Nephritis (AIN)

Medline Plus defines AIN as "a kidney disorder in which the spaces between the kidney tubules become swollen (inflamed). This can cause problems with the way your kidneys work."

This is often diagnosed after a kidney biopsy procedure is done, which often consists of a thin biopsy needle inserted into the back.

2. Chronic Kidney Disease (CKD)

According to Medline Plus, "Chronic kidney disease (CKD) means that your kidneys are damaged and can't filter blood as they should. This damage can cause wastes to build up in your body."

There are five stages of CKD, and kidney function slowly declines from one stage to the next.

3. Acute Kidney Injury (AKI)

Medscape defines acute kidney injury (AKI) as "an abrupt or rapid decline in renal filtration function."

The Abstract of the article, PPIs and Kidney Disease: from AIN to CKD provides some valuable information as it relates to PPIs and the aforementioned conditions:

While PPIs have an excellent overall safety profile, concerns have been raised about adverse renal events, specifically their association with acute interstitial nephritis (AIN)...PPI-induced AIN is often subtle and without systemic allergic manifestations; subclinical, leading to gradually progressive kidney failure; delayed, median time from drug initiation to AIN diagnosis often exceeds 6 months; and often unsuspected prior to a biopsy. While the association between PPIs and AIN is well described, the population incidence of PPI-induced AIN and its contribution to the burden of chronic kidney disease (CKD) was unclear, until recently.

The aforementioned study concluded that patients who were prescribed PPIs not only had a higher risk of AIN, but also CKD and acute kidney injury.

4. End-Stage Renal Disease (ESRD) / Kidney Failure

ESRD is also called kidney failure or end-stage kidney disease, which Medline Plus defines as "the last stage of chronic kidney disease. This is when your kidneys can no longer support your body's needs."

The article, Proton Pump Inhibitors and Risk of Incident CKD and Progression to ESRD, confirms the findings of the aforementioned article, saying their "results suggest that PPI exposure associates with increased risk of incident CKD, CKD progression, and ESRD.

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It is very important to note that diabetes and high blood pressure (hypertension) are common causes of the aforementioned kidney issues.  Having either one of these conditions (or other preexisting conditions) may prove to be a challenging legal obstacle if a patient decides to pursue a lawsuit against the manufacturers of Nexium, Prilosec, or Prevacid after using these drugs and suffering significant kidney damage.

In my next article of this series, I will discuss exactly what was known about the relationship between PPIs and kidney damage, and at what time such information was made available.

Until then, we will continue to monitor the medical literature concerning Nexium, Prilosec, and Prevacid and their link to kidney injuries.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

Nexium / Prevacid / Prilosec Series: Overview and Background

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

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Series Overview:

Article 1 – Overview and Background
Article 2 – The Devastating Side Effects
Article 3 – Why Weren’t We Warned Sooner?
Article 4 – Factors for Drug-Injury Lawsuits

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To start my series on Nexium, Prevacid, and Prilosec, I would like to provide some background information on these drugs, as well as a quick overview of their detrimental side-effects.

For many years, popular heartburn and acid reflux drugs like Nexium, Prilosec, and Prevacid have been touted as safe by the drug manufacturers and doctors alike.  However, there has been extensive medical literature linking them with kidney injuries for the past two decades.

These drugs are known as Proton Pump Inhibitors (PPIs), and are approved by the FDA to treat gastroesophageal reflux disease (GERD), dyspepsia, peptic or stomach ulcers, Zollinger-Ellison syndrome, and frequent heartburn (on a short-term basis).  They may be obtained over-the-counter or by prescription.

As previously discussed, there have been numerous studies linking these PPIs to various kidney injuries.  Unfortunately, patients have not been warned of the possible kidney-related side effects of these drugs until fairly recently, in 2014.

To make matters worse, those who have used Nexium, Prilosec, and Prevacid (amongst other PPIs) for an extensive period of time are at an even higher risk of kidney injury than those who simply use these drugs on a short-term basis.  This occurrence is further discussed in the article, "How Long-Term Use Of Heartburn Drug Nexium Might Cause Kidney Problems."

Some of the possible side-effects of these drugs are as follows:

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

I will discuss these specific conditions in more detail in the next article of my Nexium / Prevacid / Prilosec series.

In the meantime, we will continue to monitor the medical literature concerning these PPIs and their link to kidney injuries.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information