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