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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?


To: Anthony Wong who wrote (8229)10/14/1999 6:17:00 PM
From: Anthony Wong  Read Replies (2) | Respond to of 9523
 
FDA Advisory Panel Recommends Zoloft For Posttraumatic Stress Disorder

NEW YORK, NY -- October 14, 1999 -- An advisory
panel of the U.S. Food and Drug Administration
recommended its anti-depressant Zoloft (sertraline
hydrochloride, Pfizer Inc.) for an indication of
posttraumatic stress disorder (PTSD).

Zoloft is the first medicine to receive a FDA advisory
panel approval recommendation for the treatment of
PTSD. Zoloft is currently indicated for major depression,
panic disorder, and obsessive-compulsive disorder.

Patients suffering from PTSD experience significant
distress or impairment in normal functioning. A traumatic
event involves reaction to serious injury or other physical
threat. Symptoms can include re-experiencing the
traumatic event, commonly known as flashbacks, overall
emotional numbness, or increased anxiety.

Approximately 50 percent of the general population are
exposed to a traumatic event during their lifetime. Ten to
twenty percent of those develop PTSD. The prevalence
of PTSD is twice as high in women as in men.

More than 100 million prescriptions for Zoloft have been
written in the United States since its approval in 1992.
Pfizer said it will continue providing information about its
PTSD clinical trials program to the FDA during the
agency's review process.

Zoloft is contraindicated until at least 14 days have
passed since discontinuing a monoamine oxidase inhibitor
(MAOI) and a MAOI is contraindicated for at least 14
days after discontinuation of Zoloft. The most common
side effects in adults with depression, panic disorder,
obsessive-compulsive disorder, and other premarketing
controlled trials include nausea, insomnia, diarrhea,
ejaculation failure (primarily ejaculatory delay) and
somnolence.

pslgroup.com