Pantoprazole associated dyspepsia hypocalcemia and hyponatremia: A disproportionality analysis in FDA adverse event reporting system (FAERS) database

Drugs are the chemical substances that are used for improving the health status of a patient, but if misused, they can lead to more risk than benefit. Proton Pump Inhibitors (PPI) are the acid-lowering medications used in the treatment of Gastro Esophageal Reflux Disease (GERD), Peptic Ulcer Disease (PUD), Helicobacter pylori infection, Zollinger-Ellison Syndrome (ZES), dyspepsia, etc [1], [2], [3]. Studies show that in the United States alone, more than 7 % adults have been on prescription PPI and many more have been consuming PPIs acquired over the counter. PPIs irreversibly bind to hydrogen/potassium pump in parietal cells and thus reduce the gastric acid secretion [[1], [4]].

Though there is no evidence to show an increase in prevalence or increased morbidity due to gastrointestinal diseases or a decrease in H2–Receptor Antagonist (H2RA) use, there has been a rapid increase in the frequency of PPI prescription showing that PPI is being used licentiously even for minor complaints and patient demand for PPI is increasing for abiding by their poor lifestyle [5]. Yet again, the loss of patent protection of PPIs, has led to increased availability and affordability of PPIs in many countries [1]. But evidence indicates that this may lead to Adverse Drug Reactions (ADR) such as osteoporosis, pneumonia, hyponatremia, hypomagnesemia, Clostridium Difficile Infection (CDI), vitamin-B12 deficiency (dementia, neurologic damage, and anemia) and other ADRs such as hepatotoxicity, renal toxicity, bone marrow toxicity, Fundic Gland Polyps (FGP) and anaphylaxis [[6], [7], [8], [9], [10], [11]].

Due to limited subject size and duration of exposure, it is very challenging to determine all the ADR in clinical trials, making signal generation one of the critical methods to detect any new Adverse Events (AE). World Health Organization (WHO) defines a signal as “reported information on a possible causal relationship between an AE and a drug, of which the relationship is unknown or incompletely documented previously” [[12], [13], [14], [15]].

Pantoprazole is a potent and affordable medication that is readily available as an Over The Counter medication (OTC), making it vulnerable to overuse. Disproportionality analysis is a quick and inexpensive method to determine the presence and assessment of the strength of ADR signals [16].

Though there is not much literature stating the occurrence of specific ADR of PPI, our study aims to generate a signal for unreported adverse drug reactions of pantoprazole using disproportionality analysis FAERS database [12].

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