FDA reviews labels on antidepressants

By Elizabeth Shogren
Los Angeles Times

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His family physician prescribed Paxil, a popular antidepressant. But Baadsgaard, then 16, sunk deeper into depression. The doctor switched him to a different antidepressant, Effexor, and stepped up the dose over a three-week period from 40 milligrams to 300. The first morning Baadsgaard took 300 milligrams, he felt rotten and went back to bed.

Three years later, he says, he still has no memory of what happened next: no memory of taking a high-powered rifle into his English class in Mattawa, 50 miles southwest of Moses Lake in Grant County, of herding his classmates and teacher into a corner, of holding them at gunpoint for 45 minutes, of being talked by the principal into giving up his gun.

He spent 14 months in a juvenile detention center.

Baadsgaard and his father think the antidepressants made him suicidal at first, then violent. The Food and Drug Administration (FDA) — based on such anecdotal evidence and results of clinical trials — is reconsidering its decision not to require that doctors and parents be warned about possible side effects of the drugs known as serotonin reuptake inhibitors.

The link to suicide was the focus of an FDA advisory committee meeting last month. But testimony from Baadsgaard and others who had turned violent while taking the drugs suggested to several committee members that the FDA should look more broadly into the medications' adverse effects.

Dr. Joseph Glenmullen, a Harvard Medical School psychiatrist who has studied serotonin reuptake inhibitors, wonders whether antidepressants could help explain the rash of school shootings and murder-suicides in the past decade.

People who take antidepressants, he said, could "become very distraught. ... They feel like jumping out of their skin. The irritability and impulsivity can make people suicidal or homicidal."

Added Dr. David Healy, director of the North Wales Department of Psychological Medicine: "What is very, very clear is that people do become hostile on the drugs."

Glenmullen and Healy stressed that parents, patients and doctors must be warned to look for potentially dangerous reactions. However, both said they planned to continue prescribing the drugs.

Pharmaceutical companies and many doctors dispute the suggestion that antidepressants play a role in violent or suicidal acts.
 
Dr. Alastair Benbow, the European medical director for GlaxoSmithKline, Paxil's manufacturer, refused to comment on specific cases. But, he said, "I don't believe there is any clear evidence that Paxil is linked with suicide, violence or aggression — and certainly not homicide."

The source of aggressive behavior, doctors and mental-health groups said, may lie with the illness and not the treatment. And failing to treat depression, they said, could have costs as grave as treating it.

"Suicide and violence are well-recognized outcomes of depression itself," Benbow said.

Although only one antidepressant, Prozac, is explicitly approved by the FDA for children, doctors prescribe others to young patients. Most of the drugs carry no specific warnings about increasing the risk of suicide or violence.

However, one company, Madison, N.J.-based Wyeth, warned doctors in a letter last summer that children taking Effexor in clinical trials had shown increased hostility and suicidal tendencies compared to children taking placebos. The company directed doctors not to prescribe Effexor to children.

And GlaxoSmithKline, during clinical tests on children with obsessive-compulsive disorder or depression, found that the percentage of children taking Paxil who became hostile — which was defined as everything from angry thoughts to violent acts — ranged from 6.3 to 9.2 percent. For those taking the placebo, the range was zero to 1 percent, according to published records.

In Baadsgaard's case, the violent outburst was completely out of character, said his father, Jay Baadsgaard. Corey never got into fights, his father said. In their family, he was the "hugger."

So, "as soon as it happened, we knew the drugs had to have something to do with it," Jay Baadsgaard said. Corey stopped taking the drugs while in juvenile detention, and has not had any behavioral problems since, his father said.

Seattle Times staff contributed to this report.

Copyright © 2004 The Seattle Times Company