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Paroxetine-Induced Hyponatremia in Older Adults
A 12-Week Prospective Study
Tanya J. Fabian, PharmD;
Janet A. Amico, MD;
Patricia D. Kroboth, PhD;
Benoit H. Mulsant, MD;
Sharon E. Corey, PhD;
Amy E. Begley, MA;
Salem G. Bensasi, BS;
Elizabeth Weber, RN, CNP;
Mary Amanda Dew, PhD;
Charles F. Reynolds III, MD;
Bruce G. Pollock, MD, PhD
Arch Intern Med. 2004;164:327-332.
Background Older depressed patients are at high risk for development of hyponatremia after initiation of the selective serotonin reuptake inhibitor paroxetine, despite clinical monitoring and preventive management. The purposes of this study were to determine the incidence and etiology of paroxetine-induced hyponatremia in older patients and to identify patient characteristics that may account for variability in susceptibility to this adverse event.
Methods This prospective, longitudinal study was conducted in a university-based ambulatory psychiatric research clinic from August 1999 through September 2001. Patients included 75 men and women aged 63 through 90 years (mean ± SD age, 75.3 ± 6.0 years) who received a diagnosis of a current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, major depressive episode and were prescribed paroxetine. We monitored plasma sodium levels before initiating paroxetine therapy and after 1, 2, 4, 6, and 12 weeks of treatment. In a subset of individuals, we measured levels of antidiuretic hormone, glucose, serum urea nitrogen, and creatinine. Hyponatremia was defined as a plasma sodium level of less than 135 mEq/L after initiation of paroxetine therapy.
Results Hyponatremia developed in 9 (12%) of the 75 patients after initiation of paroxetine treatment. Mean ± SD time to development of hyponatremia was 9.3 ± 4.7 days (median, 9 days; range, 1-14 days; n = 8). In the multivariate regression, lower body mass index and lower baseline plasma sodium level (<138 mEq/L) were significant risk factors for the development of hyponatremia in these patients.
Conclusions Hyponatremia is an underrecognized and potentially serious complication of paroxetine treatment in older patients. Our results provide a foundation for understanding the etiology and risk factors associated with paroxetine-induced hyponatremia.
From the Intervention Research Center for Late Life Mood Disorders, Department of Pharmaceutical Sciences, School of Pharmacy (Drs Fabian, Amico, Kroboth, Corey, and Pollock), and the Departments of Psychiatry (Drs Fabian, Mulsant, Dew, Reynolds, and Pollock; and Mss Begley and Weber; and Mr Bensasi) and Medicine (Dr Amico), School of Medicine, University of Pittsburgh, and the Geriatric Research, Education, and Clinical Center, Veterans Affairs Pittsburgh Health System (Dr Mulsant), Pittsburgh, Pa. Dr Mulsant has received research support from Forest Laboratories, Eli Lilly, GlaxoSmithKline, and Pfizer/Eisai; consultationships from Eli Lilly, Forest Laboratories, GlaxoSmithKline, and Pfizer; speakers' fees from GlaxoSmithKline, Janssen Pharmaceutica, and Pfizer/Eisai; and honoraria from Forest Laboratories, GlaxoSmithKline, Lundbeck, and Pfizer/Eisai and owns stock in Forest Laboratories, Akzo-Nobel, and Pfizer. Dr Reynolds has received research support and honoraria from Forest Laboratories and GlaxoSmithKline. Dr Pollock has received research support from Janssen Pharmaceutica, Pfizer, and GlaxoSmithKline; consultationships from Forest Laboratories, Janssen Pharmaceutica, Pharmacia & Upjohn, Organon Inc, and GlaxoSmithKline; and speakers' fees from Forest Laboratories, Janssen Pharmaceutica, Lundbeck, Organon Inc, and GlaxoSmithKline.
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