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May 17, 1995

Fluoxetine and Sexual Dysfunction-Reply

Author Affiliations

Eli Lilly and Company Indianapolis, Ind

JAMA. 1995;273(19):1490. doi:10.1001/jama.1995.03520430025023

In Reply.  —Sexual dysfunction can be induced by several classes of medications, including antihypertensives, antihistamines, antipsychotics, and antidepressants. Much recent attention has focused on the sexual side effects, both detrimental and beneficial, of the selective serotonin reuptake inhibitors. We hope that the following information will help to put recent reports into perspective.The package literature accompanying Prozac (fluoxetine hydrochloride) reports a smaller incidence of sexual dysfunction than those reported in more recent studies or suggested in anecdotal reports. This apparent discrepancy may be related to two factors.First, at the time of product approval, the Food and Drug Administration requires the package insert to contain certain data presented to the agency at the time of submission of the New Drug Application, as well as pertinent updates. The New Drug Application for Prozac was submitted in 1983 and included results of trials conducted through the end of 1982. Adverse drug events

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