Researchers Suggest Pharmaceutical Companies And FDA Should Reconsider OTC Availability Due To Inappropriate Use Of Nexium As Well As Prilosec and Prevacid
A team of medical researchers recently examined the so-called "mechanism of injury" for the long-term use of Nexium -- and perhaps other heartburn or reflux medications in the proton pump inhibitor (PPI) class of drugs -- apparently causing an increased risk of kidney problems as well as heart attacks and dementia.
As background, there is a growing body of medical evidence which indicates that some popular heartburn drugs and acid reflux medicines like Prevacid, Prilosec, and Nexium can cause some serious kidney-related side effects. In more detail, the use of these proton pump inhibitors (PPIs) for even just a couple of weeks can result in an increased risk of developing:
- Acute Interstitial Nephritis (AIN)
- Chronic Kidney Disease (CKD)
- End-Stage Renal Disease (ESRD)
- Severe Renal Impairment
- Kidney / Renal Failure
- Acute Kidney Injury
Further, there is at least one medical study which shows the correlation between a longer time period of Prevacid, Prilosec, and Nexium use, and an increased risk of developing these serious kidney or renal conditions.
As for this recent medical research report, "Proton Pump Inhibitors Accelerate Endothelial Senescence", it was published online as a Brief UltraRapid Communication by the Circulation Research medical journal during May 2016.
From the Abstract for this report:
Rationale: Proton pump inhibitors (PPIs) are popular drugs for gastroesophageal reflux, now available for long-term use without medical supervision. Recent reports suggest that PPI use is associated with cardiovascular, renal and neurological morbidity.
Objective: To study the long-term effect of PPIs on endothelial dysfunction and senescence and investigate the mechanism involved in PPI induced vascular dysfunction.
Methods and Results: Chronic exposure to PPIs impaired endothelial function and accelerated human endothelial senescence by reducing telomere length.
Conclusions: Our data may provide a unifying mechanism for the association of PPI use with increased risk of cardiovascular, renal and neurological morbidity and mortality.
Strictly Confidential, No Obligation.
For a more in-depth look into this recent medical research, we get this additional information from the Introduction part of the full-text version of the report:
Proton pump inhibitors (PPIs) like Esomeprazole (Nexium) are widely used drugs for the treatment of gastroesophageal reflux disease (GERD). In the US these drugs are sold over-the-counter and thus medical supervision is not required. Although these agents are effective, they were never approved by regulatory authorities for long-term use. Furthermore, evidence suggests that up to 70% of PPI use may be inappropriate.
Recent large and well-controlled epidemiological and retrospective studies have found associations between the use of PPIs, and an increased prevalence of myocardial infarction, renal failure, and dementia. However, in the absence of a mechanism and without evidence of causality, global regulatory authorities have not restricted the use of PPIs. In this paper, we provide evidence that chronic exposure to proton pump inhibition accelerates senescence in human endothelial cells, a unifying mechanism which may explain the association of adverse cardiovascular, renal and neurological effects with the use of PPIs. [footnotes omitted; emphasis added]
And going to the end of the Discussion part, we get this summary statement:
To conclude, we find that chronic exposure of human endothelial cells to the PPIs [Nexium (Esomeprazole)] or SCH-28080 [(another H+K+ ATPase inhibitor with a potency similar to omeprazole, IC50 of 2.5 and 4.0μM respectively)] accelerates endothelial aging. This adverse effect appears to be due to an inhibition of lysosomal acidification and subsequent impairment of proteostasis. The accumulation of protein aggregates is associated with an increase in oxidative stress, endothelial dysfunction and senescence. Vascular senescence would provide a mechanistic explanation11-13 for the accumulating evidence that PPIs increase the risk of cardiovascular morbidity and mortality, renal failure, and dementia. In the presence of consistent epidemiological evidence of harm, and a unifying mechanism for the disparate disorders linked to PPI use; and with the knowledge that PPIs are being used by millions of people for indications and durations that were never tested or approved; it is time for the pharmaceutical industry and regulatory agencies to re-visit the specificity and the safety of these agents. [footnotes omitted; emphasis added]
To get a better understanding of that rather complex information, we turn to this May 12, 2016 Reuters Health article, "Proton Pump Inhibitors Accelerate Cellular Aging":
PPIs impair the ability of the lysosomes in vascular cells to generate acid. Lysosomes function as "garbage disposals for the vascular cells (and) they can't work well if they can't generate acid," lead investigator Dr. John Cooke of Houston Methodist Research Institute in Texas told Reuters Health by email.
"Doctors have been giving the PPIs with the understanding that these drugs are specific for the acid pump in the stomach. What we have found is that another acid pump is affected, and this causes 'garbage' (damaged proteins) to aggregate in the cells, (which) causes the cells to age faster," he explained.
"This study provides a plausible unifying mechanism for accumulating reports that PPI users are at increased risk for heart attack, kidney problems, and dementia," Dr. Cooke said....
"The health of our blood vessels is necessary for normal functioning of our heart, brain, and kidneys. Damage to the lining of our blood vessels could lead to heart attack, dementia and renal failure. The pharmaceutical industry and regulatory authorities should reconsider the use of these agents without medical supervision. Physicians should be more cautious in their prescription of these drugs," Dr. Cooke told Reuters Health.
We will continue to monitor the safety profile of Nexium as well as other PPI heartburn drugs such as Prilosec and Prevacid.
We are currently investigating possible drug injury lawsuits for people who have developed any of the kidney-related medical problems listed above. These lawsuits are not limited to Nexium, Prilosec, and Prevacid, and can be based on any of the brand name proton pump inhibitors (PPIs) heartburn drugs and acid reflux medicines, whether they were obtained by prescription and/or over-the-counter