Warning On Antidepressants
British agency: For children, risks exceed rewardsDec 11, 2003 | Washington Post
British health authorities warned doctors yesterday against prescribing most newer antidepressant drugs to children, saying the benefits of popular medications such as Zoloft, Celexa, and Lexapro are outweighed by the risks of triggering suicidal thoughts, self-injury, and agitation.
In a stark warning that comes as the US Food and Drug Administration is doing its own review of the safety of the same medications for children, the Medicines and Healthcare Products Regulatory Agency said the benefits outweigh the risks only for Prozac, the first of the modern generation of antidepressants.
"The experts have decided these medicines may do more harm than good in the treatment of depression in under-18s," the British agency said in a leaflet given to patients. Previously, British regulators had warned against giving Paxil and Effexor to children.
The FDA is using "a fine-toothed comb" to reexamine 20 studies of eight antidepressants, an official said. The agency has asked the drug companies that did the studies to provide the data in a format that makes comparisons easier. An FDA panel of experts is expected in February to consider the safety of giving the drugs to children.
Russell Katz, director of the FDA's division of neuropharmacological drug products, said the US analysis will be more detailed than the British review. Combining different studies allows regulators to compare the collective risk of suicidal thoughts and agitation in depressed children who took the drugs vs. those who got dummy pills. More than 4,100 children participated in the 20 studies.
The medications being evaluated are called selective serotonin reuptake inhibitors, or SSRIs. Over the past decade, SSRIs have become the medicine of choice for treating depression in adults.
While only Prozac has been specifically approved for children with depression, some studies indicate that the use of SSRI prescriptions for children is rapidly rising.
One study this month in the Archives of General Psychiatry concluded that about 1 percent of American children are treated for depression in any year and 57 percent of them get antidepressants, said Mark Olfson, a professor of clinical psychiatry at Columbia University and the lead author.
"The treatment guidelines indicate these medications are recommended only for children with more severe depressions and those who have failed psychotherapy," Olfson said in an interview. "One would have expected a smaller number."
While Olfson's study did not analyze why so many children were given antidepressants the vast majority got SSRIs he said the lack of trained child psychiatrists and psychologists might be prompting a swifter resort to prescription pads. Also, he added, many managed health insurance plans provide financial incentives to choose medication over psychotherapy drugs are cheaper than talk therapy for families and insurance plans.
Vera Sharav, a patients' rights advocate and critic of the drugs, said conflicts of interest among regulators and scientists and proprietary rules that allowed companies to keep data secret have subverted the scientific process. She said the British decision has "been a long time coming."
Regulators and psychiatrists rejected charges of bias, saying that the science was subtle and often unclear. None of the children in the 20 trials being evaluated, for instance, committed suicide, and the studies all used different terms to categorize various aspects of suicidal behavior.
Olfson said another study he conducted appeared to show lower rates of suicide among children in parts of the country where antidepressants were most commonly prescribed: "It doesn't tell you the antidepressants are preventing suicides, but something in those regions has contributed to a decline in suicide," he said.
Adelaide Robb, an adolescent psychiatrist at Children's National Medical Center in Washington who has helped conduct some of the trials for drug companies, said British regulators had overreacted potentially placing children at risk.
"If countries start to say medications are too dangerous for children, you have a bunch of kids who don't get treatment and will continue to suffer from depression," she said. "That has a high suicide rate itself."