title: Omeprazole- and esomeprazole-associated hypomagnesaemia: data mining of the public version of the FDA Adverse Event Reporting System.
abstract: OBJECTIVE
  Case reports showing that proton-pump inhibitors (PPIs), omeprazole and esomeprazole, can cause hypomagnesaemia have been accumulating since 2006. In this study, the reports submitted to the Adverse Event Reporting System (AERS) of the US Food and Drug Administration (FDA) were evaluated to assess omeprazole and esomeprazole in terms of susceptibility to hypomagnesaemia.
  
  
  METHODS
  After a revision of arbitrary drug names and the deletion of duplicated submissions, the reports involving omeprazole and esomeprazole were analyzed. Standardized official pharmacovigilance tools were used for the quantitative detection of a signal, i.e., an association between a drug and an adverse drug event, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean.
  
  
  RESULTS
  A total of 22,017,956 co-occurrences were found in 1,644,220 reports from 2004 to 2009, where a co-occurrence was a pair of a drug and an adverse drug event. In total, 818 and 743 adverse drug events were listed as omeprazole- and esomeprazole-associated, with hypomagnesaemia ranking 85th and 135th, respectively. Although both PPIs were associated with hypomagnesaemia, the statistical metrics suggested that the association was more noteworthy for omeprazole.
  
  
  CONCLUSIONS
  The data obtained in this study do not provide sufficient evidence to recommend systematic monitoring of magnesium levels in plasma, but chronic exposure to a PPI can lead to severe hypomagnesaemia.
authors: Kinki University Nara Hospital, Nara, Japan.
authors: Takao
authors: T
authors: Tamura
authors: Toshiyuki
authors: T
authors: Sakaeda
authors: Kaori
authors: K
authors: Kadoyama
authors: Yasushi
authors: Y
authors: Okuno
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D057225:Data Mining; D004791:Enzyme Inhibitors / Q000009:adverse effects*; D064098:Esomeprazole; D006801:Humans; D053565:Hypercalciuria / Q000139:chemically induced*; D009397:Nephrocalcinosis / Q000139:chemically induced*; D009853:Omeprazole / Q000009:adverse effects*; D015499:Renal Tubular Transport, Inborn Errors / Q000139:chemically induced*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004791:Enzyme Inhibitors; D009853:Omeprazole; D064098:Esomeprazole