Kara Jaye-Anne Otter, 12, had been on the antidepressant Paxil for seven months when she committed suicide. "I was told the worst side effects would be flulike symptoms," recalls her mother, Shannon Baker. "But after three weeks she had begun to cop an attitude. Her grades started falling. Then she didn't care what she looked like, and she was fighting with everybody." Baker says her daughter developed rashes and dark circles under her eyes and had trouble sleeping. Then, on June 7, 2001, Kara pinned a note to her chest reading, "By the time you find me I'll be dead. I love you with all my heart. Don't worry, Jesus is with me." She hooked a bungee cord onto a plate hanger on the wall, wrapped the cord around her neck and pulled against it until she passed out. Within minutes she was dead.
Baker is convinced Paxil is what killed her daughter, and that's what she'll tell a U.S. Food and Drug Administration panel meeting this week in Bethesda, Md. For years a small but vocal group of patients and doctors have insisted that certain antidepressants, including Paxil, Zoloft, Prozac and other medications known as selective serotonin reuptake inhibitors (SSRIs), carry an unacceptable risk of antisocial behavior and suicide in kids who take them. Many clinicians and most pharmaceutical companies disagree. Major depression is a dangerous illness that in itself can lead to suicide, and they insist that the benefits of these drugs outweigh the risks. But drug firms also refuse to release all their research--some of which tends to undercut their claims. "It's a real shell game here," says Vera Sharav, president of the Alliance for Human Research Protection, an advocacy group.
The issue is coming to a head. By last December, the British Medicines and Healthcare Products Regulatory Agency, the equivalent of the FDA, had declared Celexa, Effexor, Lexapro, Luvox, Paxil and Zoloft (but not Prozac) too risky for kids under 18. Two weeks ago, a task force of the American College of Neuropsychopharmacology fired back, saying that despite the risk of potentially serious side effects, it's riskier to withhold the drugs.
Now comes the FDA probe, which began with an investigation of Paxil launched in the fall of 2002. Last June the FDA cautioned doctors against prescribing the drug to young people because of a possible increase in suicidal thinking. In October the FDA issued a broader public-health advisory alerting physicians that in clinical trials, Paxil, along with about half a dozen other antidepressants, wasn't any more effective than a placebo at treating depression in kids. Indeed, no antidepressant other than Prozac has been formally approved for young people. But that's not the same as a ban. Once a drug is legal, doctors can prescribe it at will.