NEW YORK, (Reuters Health) -- The US Food and Drug Administration
(FDA) approved the antidepressant Zoloft (sertraline hydrochloride) on Tuesday
for the treatment of post-traumatic stress disorder (PTSD).
The move makes Zoloft the first drug to be approved for use in patients
with PTSD. In addition to its use in depression, Zoloft is also used to treat
obsessive-compulsive disorder and panic disorder.
PTSD follows a traumatic experience that involved a risk of death or
serious injury. Symptoms include irritability, sleep disturbances, outbursts of
anger, emotional numbness, flashbacks, and avoidance of events and places that
are reminders of the event.
In a statement, FDA officials reminded physicians that a PTSD diagnosis
"requires that the symptoms be present for at least a month and that they cause
clinically significant distress or impairment in social, occupational, or other
important areas of functioning."
Approval was based on results of two clinical trials involving adults with
a diagnosis of PTSD. The drug had positive effects in females in the study, but
not males. "The importance of this apparent gender difference is unknown,"
according to an FDA statement.
Side effects of the drug include dry mouth, sleepiness, and
gastrointestinal distress.
