Do no harm

February 13, 2004

TESTIFYING BEFORE the Food and Drug Administration about the effects of antidepressants on their children, Sara Bostock and Suzanne Vogel-Scibilia graphically illustrated the dilemma facing the federal agency. Ms. Vogel-Scibilia said the medications had enabled her two children to lead full and productive lives. Ms. Bostock's daughter, Cecily, stabbed herself to death two weeks after starting on the drug Paxil.

The consequences of issuing a warning on these drugs - known as selective seratonin reuptake inhibitors (SSRIs) - are indeed grave, and the FDA has chosen wisely to proceed with caution. Its decision to seek an independent review of industry-sponsored drug trials on SSRIs should help clarify a situation beset by flawed data, emotional personal stories and doubts about the efficacy of the drugs. Until then, parents of children on the medications should keep a close eye on the children's behavior and confer routinely with their physicians or psychiatrists.

Most of us know these medications by their brand names: Prozac, Zoloft, Paxil, Luvox, Celexa, Wellbutrin, Effexor, Serzone and Remeron. Questions arose about suicidal tendencies in children who take the drugs over a year ago, but Britain's decision in December to restrict use of the medications in children pushed the issue to the forefront. As many as 2.1 million American children take the drugs. So why shouldn't the United States follow Britain's lead?

The truth is that none of the trials in which 4,000 children participated conclusively attributed suicidal tendencies to use of the drugs. And, more to the point, clinicians and researchers have identified a series of flaws in the trials, most notably that the drug companies never determined if SSRIs were effective in children. Also, the drug trials were not designed to test whether the medications caused suicidal tendencies.

The inconsistencies, questions and conflicts in the trials require a second, more intensive review of the data, which the FDA has asked researchers at Columbia University to do. Until the teams return with their findings in the summer, parents should proceed with an abundance of caution.

Medication should be only one aspect of a treatment plan that includes therapy with a mental health professional. Physicians should engage parents and patients in a conversation about the FDA's findings to prevent hasty, uninformed decisions to stop taking their medication.

But the practice of prescribing medications - whatever they may be - that have not been tested on children needs to be re-evaluated. Changes in the health care delivery system, restrictions on mental health coverage and the limited availability of child psychiatrists (there are only 6,000 in the country) require that pediatricians and family physicians be properly trained in the use of psychotropic drugs.

Suicide remains a serious problem among youths. The FDA-sponsored review of SSRIs will help save lives, no matter its conclusion.

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