Problems assessing nonserious adverse drug reactions: antidepressant drug therapy and sexual dysfunction.
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.
Michels
K B
KB
Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts 02115, USA.
D016907:Adverse Drug Reaction Reporting Systems; D000928:Antidepressive Agents / Q000009:adverse effects*; D006801:Humans; D011358:Product Surveillance, Postmarketing; D020018:Sexual Dysfunctions, Psychological / Q000139:chemically induced*
D000928:Antidepressive Agents