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The McClatchy Co.

Local News Saturday, April 10, 2004

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FDA urges monitoring for antidepressant users

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(Published March 23 2004)

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.

jump starts here

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

 

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