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FDA Probes Downsides of Antidepressants

Cases of youths turning violent while taking the drugs lead panel to examine possible links to adverse behavior, especially in minors.

March 21, 2004|Elizabeth Shogren | Times Staff Writer

WASHINGTON — A popular honors student who played on his varsity high school basketball and baseball teams in rural Washington state, Corey Baadsgaard nevertheless would come home complaining that no one liked him.

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 said, he still has no memory of what happened next: no memory of taking a high-powered rifle into his third-period English class, of herding his classmates and teacher into a corner, of holding them at gunpoint for 45 minutes, of being persuaded by the principal into giving up his gun.

He spent 14 months in a juvenile detention center.

Baadsgaard and his father believe the antidepressants made him suicidal at first, then violent. The Food and Drug Administration -- based on such anecdotal evidence and the 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 members of the committee that the FDA should look more broadly at the medications' adverse effects.

Dr. Joseph Glenmullen, a Harvard Medical School psychiatrist who has studied serotonin reuptake inhibitors, said Baadsgaard's story was plausible. And he wondered whether antidepressants could help explain the rash of school shootings and murder-suicides over the last decade.

People who take antidepressants, Glenmullen said, can "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 emphasized that parents, patients and doctors should be warned to watch for potentially dangerous reactions. However, both said they planned to continue prescribing the drugs to their patients.

The 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 he didn't believe there was "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 explained, could have consequences 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 routinely prescribe others to their young patients. The National Mental Health Assn. estimates that depression affects 1 in 33 children and 1 in 8 adolescents; Healy believes young people account for 1 million of the 20 million Americans who take antidepressants annually.

Most of the drugs carry no specific warnings about increasing the risk of suicide or violence.

But 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 with 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%. For those taking the placebo, the range was zero to 1%, according to published records.

Benbow said the trials provided evidence of increased hostility in children, particularly among those younger than 12 and with obsessive-compulsive disorder.

But Dr. Timothy Wilens, a pediatric pharmacologist at Massachusetts General Hospital in Boston, said that when he and his colleagues treated 82 children with antidepressants for a variety of psychiatric problems, "there were no serious outcomes" like suicide or homicide. Although a quarter of the patients had adverse responses like agitation, aggression, increased depression or irritability, Wilens said he didn't "know of any evidence that these medicines turn people into predators."

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