Home » Drug Information » FDA-Approved Drugs » 1997
Medical Areas: Psychiatry/Psychology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Pfizer
Approval Status: Approved July 1997
Treatment Area: panic disorder
The U.S. Food and Drug Administration cleared Pfizer to market
Zoloft (sertraline HCl) for the treatment of panic disorder. Zoloft
also received new labeling for maintaining antidepressant efficacy
for up to 52 weeks in the treatment of depression. Zoloft was
introduced for the treatment of depression in 1992 and, in 1996,
for obsessive-compulsive disorder. The new clearance specifies that
Zoloft may be marketed for the treatment of panic disorder, with or
without agoraphobia.
In clinical trials with adult patients, Zoloft demonstrated
significant reduction in frequency of panic attacks without regard
to age, gender or race. Patients suffering from panic disorder
experience recurrent, unexpected panic attacks. The more common
symptoms include heart palpitations, sensations of shortness of
breath, dizziness and fear of losing control or going crazy. Panic
attacks, or the fear of them, can also result in worry, concern or
even dramatic behavioral and lifestyle changes.
The most common side effects were diarrhea, ejaculation failure,
tremor, constipation, agitation, increased sweating, anorexia, and
decreased libido.
Panic disorders is a disease which will afflict an estimated
four to eight million American adults at some point in their lives.
Agoraphobia is an incapacitating anxiety that can restrict people
to their homes. Panic disorder is two to three times more prevalent
among women. Onset occurs between late adolescence and the
mid-30s.