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Severe Hyponatremia Is Often Drug Induced: 10‐Year Results of a Prospective Pharmacovigilance Program
Author(s) -
Ramírez Elena,
Rodríguez Amelia,
Queiruga Javier,
García Irene,
Díaz Lucía,
Martínez Lucía,
Muñoz Raúl,
Muñoz Mario,
Tong Hoi Y.,
Martínez José Carlos,
Borobia Alberto M.,
Carcas Antonio J.,
Frías Jesús
Publication year - 2019
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1562
Subject(s) - medicine , hyponatremia , pharmacovigilance , interquartile range , culprit , prospective cohort study , incidence (geometry) , adverse effect , adverse drug reaction , drug , pediatrics , pharmacology , physics , myocardial infarction , optics
We conducted a prospective evaluation of drug‐induced severe hyponatremia (adverse drug reaction (ADR)) through the Prospective Pharmacovigilance Program from Laboratory Signals at Hospital over a period of 10 years. Cases of serum sodium (Na(s)) < 116 mM were recorded from July 2007 to June 2017 (first period). Also cases of Na(s) 116–122 mM were recorded from July 2012 to June 2017 (second period). Drugs were the primary cause of severe hyponatremia. The incidence rate of Na(s) < 116 mM by drugs was increased threefold over the decade. Compared with other causes of hyponatremia, patients with adverse drug reaction–serum sodium (ADR‐Na(s)) in the first period were older (79 years (interquartile range ( IQR ) 68.6–89 vs. 65 years ( IQR 48–81); P < 0.001) and were more often women (70.8% vs. 48.9% men, P < 0.001); in the second period were also older (79 years ( IQR 65.3–89) vs. 63 years ( IQR 46–80.6); P < 0.001) and were more often women (70% vs. 53%, P = 0.002), and ADR‐Na(s) occurred more often in summer. The most frequent therapeutic groups of culprit drugs were the cardiovascular system and nervous system. The 65.3% in the first period and 71.2% in the second period of the ADR‐Na(s) cases responded to hydration and had been diagnosed with hypovolemic hyponatremia.