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FDA orders strong 'black-box' warnings on antidepressants used by children


3:00 p.m. October 15, 2004

WASHINGTON – The Food and Drug Administration on Friday ordered that all antidepressants carry "black box" warnings that they "increase the risk of suicidal thinking and behavior" in children who take them.

Patients and their parents will be given medication guides that include the warning with each new prescription or refill.

Dr. Lester Crawford, acting FDA commissioner, said the agency based its decision on the "latest and best science."

"We continue to believe, however, that these drugs provide significant benefits for pediatric patients when used appropriately," he told reporters.

Warning label

Text of the "black box" warning that the Food and Drug Administration ordered included on all antidepressants:

Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of (drug name) or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. (Drug name) is not approved for use in pediatric patients except for patients with (approved pediatric claim).

Pooled analyses of short-term (four to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4,400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events on drug was 4 percent, twice the placebo risk of 2 percent. No suicides occurred in these trials.


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"Antidepressants increase the risk of suicidal thinking and behavior ... in children and adolescents with major depressive disorder and other psychiatric disorders," the warning begins. Those risks must be balanced against clinical need, the label indicates in a warning surrounded by a black box, hence the "black box" designation.

The information guide, available within weeks for patients and their parents, echoes those warnings.

The FDA's action, which follows to the letter a recommendation of its advisers, was driven by data that showed that on average, 2 percent to 3 percent of children taking antidepressants have increased suicidal thoughts and actions. Independent experts, working with Columbia University, based the finding on a review of data from 24 trials that involved more than 4,400 patients taking antidepressants. They found a greater risk during the first few months of treatment.

Crawford said suicides among youths decreased by 25 percent in the last decade, as antidepressant prescriptions to children soared. Children aged 1 to 17 now account for 7 percent of all antidepressant prescriptions.

The American Psychiatric Association expressed concern that the agency's actions may lead to fewer antidepressant prescriptions for patients most in need. "This would put seriously ill patients at grave risk," the association said in a statement.

Eli Lilly and Co., which manufactures Prozac, the only antidepressant found to be safe and effective for children, echoed the APA's concerns.

"Lilly supports the recent FDA efforts," the company said. However, a "black box warning on antidepressants may have a dangerous effect on appropriate prescribing for patients who urgently need proven treatment options."

The FDA said that concern was raised during advisory committee meetings and in its internal discussions. Still, the black box is the best way to ensure patients and doctors discuss the risks and benefits of the drugs.

"We felt that it's one of the most important tools we have to get the message out to people that these drugs shouldn't be used casually," said Dr. Sandra Kweder, acting director of the FDA's Office of New Drugs.

Other drug manufacturers endorsed the FDA's action.

"We agree with the FDA that providing additional information to everyone – from health care professionals to parents and patients – is one of the most positive steps that can be taken to advance the diagnoses and treatment of adolescents with depression," said Mary Anne Rhyne, a GlaxoSmithKline spokeswoman.

Glaxo, the maker of Paxil, settled a lawsuit filed by New York's attorney general by releasing summaries of all its clinical trials. The lawsuit accused the company of not disclosing fully negative information about Paxil's safety record.

The FDA said parents and physicians will be advised to look for warning signs in children that include worsening depression, agitation, irritability and unusual changes in behavior. Those worrisome signs could come within the first months of starting an antidepressant or if the drug's dosage is changed, higher or lower.

Doctors and families are asked to have at least weekly, face-to-face contact with a child taking an antidepressant during the first four weeks of treatment. Biweekly visits would occur for eight more weeks and, as needed, after week 12.

The warning notice says caregivers and physicians should be equally as vigilant with adults who take antidepressants.

Kathleen Bodnar, a grieving mother, expressed the fear that the warning information will go to people receiving the drug but not necessarily to families or others who might best monitor behavior.

"If my daughter were living with me, I could be watching her every single day and notice the difference," said Bodnar, whose 21-year-old daughter, Liz Torlakson, killed herself two days after restarting an antidepressant that had been stopped because she had the flu. "If the doctor waits, even once a week, it's not going to be often enough."

Because the FDA chose its most strident alert, the warning must be included in advertising. That means a trend that startled federal advisers – free samples of antidepressants given to treat other medical conditions – also must carry warnings.

"These medications were being used outside their indications by physicians who sometimes distributed samples to the families," said Dr. Laurence Greenhill, a pediatric psychiatrist in New York. "In this case, advertising sampling always will have the black box warning on it."

The new warnings will be carried by all antidepressants, including Anafranil, Aventyl, Celexa, Cymbalta, Desyrel, Effexor, Elavil, Lexapro, Ludiomil, Luvox, Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron, Sarafem, Serzone, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.


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