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Problems Assessing Nonserious Adverse Drug Reactions: Antidepressant Drug Therapy and Sexual Dysfunction
Author(s) -
Michels Karin B.
Publication year - 1999
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1592/phco.19.6.424.31048
Subject(s) - postmarketing surveillance , medicine , adverse effect , incidence (geometry) , sexual dysfunction , antidepressant , pharmacotherapy , drug , drug reaction , pharmacovigilance , erectile dysfunction , intensive care medicine , pharmacology , psychiatry , anxiety , physics , optics
Adverse drug reactions (ADRs) pose a challenge to prescribing physicians, especially when they considerably compromise the patient's quality of life and thus affect compliance. Adverse events that do not pose a severe threat to the patient's health and are therefore considered nonserious are understudied in pharmacotherapy. Such events are seldom systematically assessed, and frequency figures are usually not reliable. An example of a nonserious ADR is sexual dysfunction associated with antidepressant therapy. This is a problem of considerable importance to patients, yet its incidence is underestimated in product information. Incidence data on sexual dysfunction would assist physicians' decision making and improve care. It is suggested that premarketing and postmarketing clinical trials and pharmacoepidemiologic studies include systematic assessment of selected and important nonserious adverse effects to provide more accurate estimates of their true incidence; and that product labeling be regularly updated to reflect postmarketing experience.