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FDA wants bold warning on drugs

Antidepressants will carry alert on youths, suicide risk

WASHINGTON — The Food and Drug Administration told drug companies Friday to put the government's most vivid warning on all antidepressants to alert doctors that the medications can increase suicidal thought and behavior in children and teens.

The warning must be printed in bold type and surrounded by a black box at the top of the labeling instructions provided to doctors. It also must be included in any advertisements for the widely prescribed antidepressants.

For all the drugs except fluoxetine, marketed as Prozac by Eli Lilly & Co., the so-called black-box warning will include the precaution that the drugs have not been approved for use in children because clinical trials have not shown them to be effective. Prozac is approved for children.

Drug companies also were directed to provide new guides with each prescription warning patients and their families that the medications can make children suicidal and advising them to monitor patients taking the medications day-to-day and report any behavioral changes to doctors. Those guides should be given to patients with each prescription dispensed by pharmacies within the next six weeks, FDA officials said.

The decision to require the warning came just a month after two FDA advisory panels urged the action.

Dr. Sandra Kweder, acting director of the FDA's office of new drugs, said the black-box warning was "one of the best tools we have to get the message out that these drugs should not be used casually."

Doctors wrote about 15 million prescriptions for the nine most popular antidepressants for children and teenagers last year, according to data from IMS Health, a pharmaceutical information company, and the FDA. Patients typically receive several prescriptions a year.

The new instructions to doctors will advise them to discuss the antidepressants with patients and their caregivers before prescribing them, and to see their young patients face-to-face at least once a week during the first four weeks of drug treatment and biweekly for the next four weeks.

Some antidepressant manufacturers expressed concern that the black-box warning would reduce the number of children who will get help from antidepressants. They stressed that depression is widespread among children and teens and, if untreated, can result in suicide.

"Our concern is that this warning may discourage physicians from prescribing antidepressants for children and adolescents who desperately need treatment and may discourage parents from seeking treatment for their children," said Morry Smulevitz, a spokesman for Eli Lilly.

Many child psychiatrists likewise opposed the black-box warning because they said it would deter parents and pediatricians from giving the medications to children even in cases in which they were called for.

"Medication can be very effective for some children and adolescents with depression," said Dr. David Fassler, a child and adolescent psychiatrist at the University of Vermont.

He pointed to a recent clinical study that found 71 percent of children taking Prozac responded positively to a combination of the drug and therapy, while only 43 percent responded positively to therapy alone.

"All treatments have both risks and benefits," Fassler added. "Parents need to learn as much as they can about all treatment options and make a decision that makes sense for their child."

Doctors who have led the charge to make the FDA restrict usage of the drugs said the agency had not gone far enough.

"On the one hand I think this is a wonderful historic step forward, but on the other hand I don't think they're doing enough to protect children," said Dr. Joseph Glenmullen, a Harvard psychiatrist who has watched patients become suicidal on antidepressants. He said the agency should have prohibited children from taking all of the drugs except Prozac, the one drug now approved for use by children. "The risk-benefit ratio doesn't justify prescribing drugs that can clearly make patients suicidal," he said.

The new warnings were hailed by parents whose children committed suicide while taking antidepressants.

Mark Miller, whose son hanged himself in 1997 a week after starting to take Zoloft, said he was "grateful that other parents will now have the warnings that we were denied."