Antidepressants and suicide
By Marilyn Elias, USA TODAY
Could antidepressants prescribed for more than 1 million U.S. children and teenagers cause some of them to attempt suicide?
The Food and Drug Administration's first public hearing on this question Feb. 2 is expected to draw polarized and emotional testimony. But the evidence needed for an answer won't be in for several months, says Russell Katz, director of the FDA's neuropharmacological division.
The FDA is re-examining 20 studies of eight antidepressants used in children. The studies didn't document a single drug-related suicide. But preliminary findings suggested that suicidal thoughts and attempts, though rare, were more common in kids taking the drugs than those on sugar pills.
Now the FDA is checking to make sure that children on antidepressants weren't more suicide-prone to start with than the placebo group and that the suicide attempts were bona fide tries. "Right now the data are quite murky," Katz says.
The FDA has asked drug companies for more information. The review may find no link between the drugs and suicidal thoughts, or a problem with some but not all antidepressants. The analysis also may find qualities—for example age, sex or length of illness—that put certain kids at higher risk, he says.
The newer antidepressants in question, called SSRIs or SSNIs, make "feel good" chemicals more available in the brain and were viewed as safe.
Now the FDA and many parents are concerned. The agency has cautioned doctors about possible risks, and in December, Britain's equivalent of the FDA advised giving none of the SSRIs to children except for Prozac, saying it's the only one whose benefits outweigh risks.
Prozac also is the sole SSRI approved by the FDA for treating depressed kids 7 to 17, but others, such as Zoloft and Celexa, can be prescribed legally "off label" since they're approved for adults.
Some scientific experts think the worry is unwarranted. Research shows that SSRI antidepressants don't increase suicidal behavior in kids, says a preliminary report out Wednesday from the American College of Neuropsychopharmacology. Depression, not the drugs, is probably causing suicide attempts, the scientists say.
There's relatively little controlled research on SSRIs in school-age children "and zippo on kids under 5," says John March, chief of child and adolescent psychiatry at Duke University Medical Center in Durham, N.C.
But national surveys suggest soaring usage among kids, up about 60% from the mid-90s to 2000. More than 1 million children and teens now receive SSRI prescriptions, estimates Julie Magno Zito, a psychiatric drug expert at the University of Maryland.
"The lack of supporting data, considering their widespread use, is surprising and disturbing," says Lawrence Diller, a behavioral pediatrician in Walnut Creek, Calif., and author of Should I Medicate My Child?
Still, many therapists say SSRIs can help kids, and untreated depression isn't benign. Major depression raises the risk of childhood suicide about twelvefold, according to federal figures. Every survey finds that most depressed kids get no treatment.
But does it have to be drugs? March, who has studied SSRIs, thinks not. Cognitive-behavioral therapy, which teaches kids to change self-defeating attitudes and behaviors, is about as effective as Prozac, "and that should be tried first," he says; drugs should be reserved for the most severely depressed, who need therapy, too.
Children on SSRIs must be monitored closely, says David Fassler, a child psychiatrist in Burlington, Vt. Although most kids have no problems on the medications, the SSRIs can spark agitation and impulsive acts, perhaps leading to suicide attempts, Fassler and other experts speculate.
However, prescribing patterns and medical economics work against the eagle-eye monitoring needed, some say. General practitioners and pediatricians, often not experts in the field, write the majority of SSRI prescriptions for kids. Also, HMOs may restrict access to busy specialists and pay for pills but not therapy, Fassler says.
Even specialists may prescribe incorrect doses of poorly studied drugs or fail to inform parents about warning signs. Mark Miller, 54, of Overland Park, Kan., believes antidepressants cost the life of his 13-year-old son, Matthew. He'll testify at the FDA hearing.
After a family move in 1996, Matthew had trouble adjusting at his new school. On the advice of school counselors, the Millers took him to a psychiatrist the next summer, though he seemed happier.
The doctor gave Mark antidepressants, and he began to act fidgety, Miller says. The morning after Mark took his seventh pill, Mark's mom found him hanging by a belt from a laundry hook in his closet.
"We have no family history of depression and didn't even have a package insert because he gave us samples," Miller says. An autopsy showed his son's body had SSRI levels suitable for a 250-pound body, though the boy weighed less than 100 pounds, he says.
But other parents will tell the FDA that SSRIs saved their kids' lives.
Sherri Walton, 45, of Paradise Valley, Ariz., says major depression runs in her family. Walton's daughters, Jordan, 14, and Katie, 12, started Prozac in the past 18 months after episodes of severe depression.
"They didn't even want to dance anymore, even though they're avid dancers; they didn't want to live, and now they're normal kids," Walton says. "I'm going to tell the FDA, 'Don't take away what gave my kids their lives back.' "
The agency expects to have enough evidence to answer the questions on suicide risk by summer, the FDA's Katz says. Another hearing is likely then, and at that time the FDA might issue a new recommendation on SSRIs and children.
Parents who want their kids off the antidepressants now should consult doctors on how to do it gradually because stopping abruptly can be harmful, he adds.
For undecided parents, new interim guidance might come Feb. 2, Katz says. "All we can say right now is, use with caution."