The
U.S. Food and Drug Administration on Monday warned doctors,
parents and patients to be on the lookout for potential
problems with antidepressants. The announcement came as a
boost to the case of a Chester County boy charged in the
deaths of his grandparents, defense attorneys said.
The FDA's public health advisory asked the makers of 10
antidepressants -- including Zoloft and Paxil, the two drugs
the Chester boy took over a five-week period -- to include
cautions on their labels that doctors should closely monitor
adults and children being treated for depression with
antidepressants, especially at the beginning of treatment or
when dosage is changed.
On Feb. 2, the FDA convened an advisory panel hearing in
Bethesda, Md., to help determine the best way to study data
from clinical trials conducted on children to see if the drugs
do pose increased risks of suicide or violence in certain
patients. More than 60 families and individuals testified,
mostly relating horror stories they blamed on the drugs.
Chester incident
Included were family members of Christopher Pittman, who is
accused of killing his paternal grandparents, Joe Frank
Pittman and Joy Roberts Pittman, in November 2001 and then
burning down their Slick Rock Road home before fleeing to
Cherokee County in a family car. He was 12.
Christopher was arrested and charged with double murder and
arson. His trial is slated to begin April 13, four days after
his 15th birthday. He is being tried as an adult and could
receive up to life in prison if convicted.
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At the FDA hearing, the boy's father, Joe D. Pittman, read
a letter to the panel written by his son. In his "Dear FDA"
letter, Christopher stated a doctor had increased his daily
dosage of Zoloft from 100 mg to 200 mg days before the
killings.
The advisory panel recommended seven weeks ago that the FDA
issue warnings about potential problems with the drugs. Until
Monday, however, the FDA had not acted. The agency's action
came as great news to Pittman's defense team.
"It certainly helps," said lead attorney Yale Zamore,
Chester County public defender. "It means there's something
solidly there."
Zamore filed papers Monday to have Andy Vickery, a
Houston-based attorney that specializes in cases involving
antidepressant side effects, join Pittman's defense team.
Vickery was the attorney in the case of Donald Schell, a
60-year-old Wyoming man who killed his wife, daughter and
infant granddaughter before killing himself. Schell had begun
taking Paxil two days before. A federal jury ruled against the
drug maker, now GlaxoSmithKline, in 2001. The company was
ordered to pay $6.4 million to the relatives of the
victims.
On Monday, Vickery said the FDA's health advisory
"strengthens our hands very considerably" when it comes to the
Pittman case.
"What this does is validate both for a judge and a jury
that we're not making this up," Vickery said. "It's a real
phenomenon."
FDA spokeswoman Susan Cruzan said the agency's action
should also be viewed as validating what the families and
others urged at February's advisory panel hearing.
Vickery hoped the action might also persuade 6th Circuit
Solicitor John Justice to rethink trying Christopher as an
adult. Justice could not be reached for comment Monday.
Since June, the FDA has investigated whether
antidepressants labeled as selective serotonin reuptake
inhibitors, or SSRIs, can cause behavioral problems, such as
suicide or violence. The probe started after studies involving
children on Paxil showed such a link may exist. The FDA's
probe includes all SSRIs.
Many experts claim the same mechanism that can drive some
patients to commit suicide could also cause them to act
violently toward others. Such extreme adverse effects are
believed to exist in less than 5 percent of patients on SSRIs.
The FDA has stated that more than 1 million U.S. children were
prescribed antidepressants last year.
Although Prozac is the only SSRI approved by the FDA to
treat depression in children, all SSRIs are widely prescribed
to depressed juveniles.
The drugs work by blocking the absorption of serotonin, a
mood-altering chemical, once it is naturally released in the
brain.
In December, the British equivalent of the FDA all but
banned doctors there from prescribing SSRIs to children after
a review raised questions about the drugs' effectiveness and
concerns about their ability to increase the risk of suicide
or violence.
Though the FDA's action on Monday was viewed as mostly
positive, the agency still stated that it is not yet clear
whether the drugs or the underlying depression are to blame
for the adverse effects.
Officials with Pfizer, the maker of Zoloft, said Monday
that depression is a serious health issue that carries an
inherent risk of suicide. The company agreed with the FDA that
patients being treated for depression should be closely
watched for symptoms of suicide behavior, whether or not they
are being treated with antidepressants.
Pfizer will work with the FDA to ensure the Zoloft label
contains the best information for doctors, said spokeswoman
Shreya Prudlo.
"We're going to work with them and we'll have to evaluate
this," Prudlo said. "This is an ongoing thing."
Some advocates still feel that the FDA has not gone far
enough.
"The FDA has been shielding the drug industry and they're
still shielding it," said Vera Hassner Sharav of the Alliance
for Human Research Protection, an advocacy group. "This is a
victory for public pressure. This is not the FDA coming to
their senses. ... If it's not the drug, then why will it now
be on the label of the drugs?"
Cruzan, the FDA spokeswoman, said the issue of whether it's
the drugs or the underlying condition will be resolved after a
team of suicide experts at Columbia University concluded their
review of the clinical trial data submitted to the FDA. The
agency will analyze discuss the findings at another hearing
this summer, Cruzan said.
Dr. Wayne Goodman, head of psychiatry at the University of
Florida College of Medicine and a FDA advisory panel member,
said recently he has no doubts based on clinical experience
that antidepressants can cause problems in certain
children.
"My feeling is there's a subgroup of children who have
adverse behavior effects," including mania, agitation,
activation, irritability and insomnia, Goodman said.
"It's conceivable that a child may be getting worse on
these drugs because of the drugs and it's mistaken for
worsening of the underlying condition. So instead of getting
better, these kids are getting worse."
Contact Jason Cato at 329-4071 or mailto:jcato@heraldonline.com
