Zoloft (Sertraline) is the world’s most popular antidepressant. This
pharmaceutical drug is produced and marketed by Pfizer and prescribed
to patients with varying levels of anxiety and depression. It is classified
as a selective serotonin reuptake inhibitor (SSRI) and currently used
to treat social anxiety disorder, posttraumatic stress disorder, obsessive-compulsive
disorder, and other similar mental disorders for adults and children
as young as six years old.
Over the past few years, Zoloft has been linked to patient reports
of increased depression and suicidal behavior. Several drug advisory
committees including the Food and Drug Administration (FDA) and the
Psychopharmacological Drugs Advisory Committee (PDAC) continue to
investigate these claims.
Pfizer began marketing the Zoloft in 1992. Today, Zoloft generates
$2 billion dollars in annual sales and is among Pfizer’s top selling
drugs. It is prescribed to both adult and pediatric patients and marketed
as a versatile drug that can treat six mood and anxiety disorders,
psychiatric and non-psychiatric disorders.
Since the early 1990s numerous world class experts have warned about
the role of SSRI-induced akathisia in violence and suicide. On March
19, 1996, the FDA wrote to Pfizer stating: “We note that there appears
to be an increased frequency of reports of suicidality in the pediatric/adolescent
patients exposed to Sertraline [Zoloft] compared to either placebo
or Sertraline-treated OCD patients. If this is in fact the case what
would be a plausible explanation?”
In February 2004, the FDA announced a request to the manufacturers
of ten antidepressant drugs, including Pfizer for Zoloft, that they
strengthen the "Warning Label" to encourage close observation for
worsening depression or the emergence of suicidal thinking and behavior.
Recently the U.S. Food and Drug Administration (FDA) issued a Public
Health Advisory on Zoloft: “Several recent scientific publications
report the possibility of an increased risk for suicidal behavior
in adults who are being treated with antidepressant medications…Taking
antidepressants may increase suicidal thoughts and actions in about
1 out of 50 people 18 years or younger. FDA has approved Zoloft for
use in children only if they have obsessive-compulsive disorder.”
Patients taking Zoloft are reminded to seek professional medical advice
regarding any adverse drug side effects or reactions. Patients should
also realize that it could be dangerous to stop taking prescription
medication, especially abruptly, and should talk with their physicians
first.
[
MORE
INFORMATION ON SSRI ANTIDEPRESSANTS]
Zoloft in the News
The FDA updates warning against Zoloft drug side effects. (Jul-08-05)
[
FDA]
Public Health Advisory issued by the FDA to warn patients taking antidepressant
medications. (Jun-30-05) [
FDA]
LEGAL NOTICE AND
DISCLAIMER: The materials
within this web site are for informational purposes only. They
are not legal advice and should not be used as such. Transmission
of the information in this web site is not intended to create,
and receipt does not constitute, an attorney-client relationship.
Internet users and readers should not act upon this information
without first seeking professional legal counsel. The information
in this web site is provided only as general information which
may or may not reflect the most current legal developments. Past
results do not guarantee the outcome of future cases. PLEASE
CLICK HERE FOR FULL WEBSITE TERMS OF USE, IMPORTANT ADVERTISING
DISCLAIMERS AND PRIVACY INFORMATION.