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In May 2007 a US court approved a settlement in a
class action lawsuit brought on behalf of everyone
in the United States who purchased Paxil or Paxil
CR prescribed for a minor. The lawsuit alleged that
GlaxoSmithKline promoted Paxil or Paxil CR for prescription
to children and adolescents while withholding and
concealing material information about the medication's
safety and effectiveness for minors. GSK denied all
claims. The settlement terms entitled everyone, who
previously purchased Paxil or Paxil CR for the child
or ward, to recover up to 100% of the documented out-of-pocket
expenses or $100, if the documentation was not available.
In the UK since 2001 lawsuits have been filed representing
people who have been prescribed Seroxat. They allege
that the drug has serious side effects, which GlaxoSmithKline
downplayed in patient information.
In March 2004 the FDA ordered a black box warning
placed on SSRI and other antidepressants, warning
of the risk for potential suicidal thinking in children
and adolescents. ABC News reported that the prescribing
of these medications to children subsequently dropped
by 20 percent. According to the Center for Disease
Control and Prevention's Annual Summary of Vital Statistics,
the suicide rate rose more than 18 percent in those
1 to 19 years old, from 2.2 per 100,000 in 2003 to
2.6 per 100,000 in 2004. In those 15 to 19 years old,
the figures reflected a more than 12 percent rise
in suicide, from 7.3 per 100,000 in 2003 to 8.2 per
100,000 in 2004. This led many experts to conclude
that the warning, and subsequent reduction in the
use of antidepressants, led to an increased suicide
rate in this age group. The finding is consistent
with an earlier finding, reported to the 2003 FDA
Advisory Committee by Dr David Shaffer, that suicide
rates in the United States fell during the 1990s,
in line with the introduction of SSRIs.
Since the FDA approved paroxetine in 1992, approximately
5,000 U.S. citizens have sued GSK. Most of these people
feel they were not sufficiently warned in advance
of the drug's side effects - including particularly
the withdrawal syndrome discussed above, after GSK
had specifically advertised the drug as "not
habit forming."
On January 29 2007, the BBC in the UK broadcast a
fourth documentary in its 'Panorama' series about
the drug Seroxat. This programme, entitled Secrets
of the Drug Trials, focused on three GSK paediatric
clinical trials on depressed children and adolescents.
Data from the trials show that Seroxat could not be
proven to work for teenagers. Also, one clinical trial
indicated that adolescents were six times more likely
to become suicidal after taking it.
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