Paroxetine (Paxil, Seroxat) is a selective serotonin
reuptake inhibitor (SSRI) antidepressant. It was released
in 1992 by the pharmaceutical company GlaxoSmithKline.
In 2006 it was the fifth-most prescribed antidepressant
in the United States retail market, with more than
19.7 million prescriptions. The prescription of this
drug is controversial because of side effects such
as suicidal ideation and withdrawal syndrome which
have resulted in legal proceedings against the manufacturer.
Paroxetine is primarily used to treat the symptoms
of depression, obsessive-compulsive disorder (OCD),
post-traumatic stress disorder (PTSD), panic disorder,
generalized anxiety disorder (GAD), social phobia/social
anxiety disorder, and premenstrual dysphoric disorder
(PMDD).
It was the first antidepressant formally approved
in the United States for the treatment of social anxiety
disorder [citation needed].
According to the prescribing information provided
by the manufacturer of Paxil brand of paroxetine GlaxoSmithKline
and approved by the FDA, the effectiveness of paroxetine
in major depressive disorder has been proven by six
placebo-controlled clinical trials. For panic disorder,
three 10-12-week studies indicated paroxetine superiority
to placebo. Similarly, three 12-week trials for adult
outpatients with social anxiety disorder demonstrated
better response to paroxetine than to placebo.
Unapproved/off-label/investigational
Double-blind studies indicated that paroxetine can
also be used in the treatment of premature ejaculation.
After receiving paroxetine for several weeks, intravaginal
ejaculation latency time (IELT) of the study subjects
increased 6-13-fold, which was longer than the delay
achieved by the treatment with other SSRIs (fluvoxamine,
fluoxetine, sertraline and citalopram). However, paroxetine
taken acutely ("on demand") 3–10 hours before
coitus resulted only in a "clinically irrelevant
and sexually unsatisfactory" 1.5-fold delay of
ejaculation and was inferior to clomipramine, which
induced a four-fold delay.
There is also evidence that paroxetine may be effective
in the treatment of compulsive gambling and hot flashes.
In two double-blind studies of bipolar disorder patients,
addition of paroxetine to a mood stabilizer had no
advantages over addition of placebo. Benefits of paroxetine
prescription for diabetic neuropathy or chronic tension
headache. are uncertain.
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