Listen up, parents:

• If your child is depressed and not being treated with antidepressants, he/she could become suicidal.
• Conversely, if your child is being treated for depression with antidepressants, he/she could begin to have suicidal thoughts.

That's the chicken and egg dilemma, say healthcare professionals. While antidepressants have saved thousands of lives, there is a growing body of evidence that shows some children and teens-as well as adults-are more vulnerable than others to one of antidepressants' most serious adverse effects: suicidal thoughts or behavior.

In October, heeding the advice of its expert panelists, the US Food and Drug Administration (FDA) declared that all antidepressants must carry a "black box" warning to alert doctors that the medications increase the risk of suicidal thoughts and behavior among children and adolescents.

Prozac is the only antidepressant approved by the FDA for use in treating depression in pediatric patients. Studies indicate that Celexa, Prozac and Zoloft posed lower risks for children while Luvox, Effexor and Paxil had higher risks of increasing suicidal thoughts/behavior.

The new warnings will be carried by all antidepressants including: Anafranil; Aventyl; Celexa; Cymbalta; Desyrel; Effexor; Elavil; Lexipro; 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.

Two FDA advisory panels grappled for months with the pros and cons of limiting the use of antidepressant medications. Suggestions ranged from issuing an outright ban to making the warning far stronger to urging extremely close monitoring especially during initial phases of drug treatment.

In mid-September, the panels convened in Washington, D.C., says FDA expert panelist Michael Fant, M.D., Ph.D., and associate professor of pediatrics at The University of Texas Medical School at Houston to determine if more stringent warning labels were needed for antidepressants. The upshot was, "yes." But the final answer did not recommend stopping the use of antidepressants for children and teens.

Final Decision by FDA

After months of studying the available (read scanty) scientific data and listening to approximately 70 people testify at an impassioned public hearing, the FDA panel declared by a 25-0 vote there was evidence that using antidepressant medications can cause suicide or suicidal thoughts in some children.

"From the limited data available, we see that two or three kids out of every 100 treated (with antidepressants) developed suicidal behaviors. Not that they would necessarily commit suicide, but that they would say and do things suggesting they were considering it," says Fant. (The U.S. investigation began last year after British health officials said that no antidepressant except Prozac should be used for children and adolescents.)

By a vote of 15-8, the panel advised the FDA to mandate that all antidepressants should carry a "black box" warning on the label saying the pills can cause suicidal behavior in children. The black box is the strongest possible warning label and is reserved for deadly drugs. The panel also said the FDA should require that fact sheets warning of the suicide risk be given out with each prescription. Information about warning signs including worsening depression, agitation, irritability and unusual behavioral changes should be included, as well. The FDA has followed the panel's advice to the letter.

Teens: a Diagnostic Riddle

"Children's mental health problems are difficult to diagnose accurately," Fant says. "What presents as major depression in childhood may turn out to be bipolar disorder. The right medication for one condition is not necessarily best for another.

"There are so many confounding variables-especially in teens," he says. "Hormones are raging. There are environmental stresses and there could be the influence of other pharmacologic agents (illegal drugs, alcohol) that the parents may not know about.

"We don't really know yet whether the suicidal thinking is part of the depression itself or due to the drugs because there have been so few clinical trials on kids for these drugs," he says.

What is clear is that medication is a highly effective part of treating depression in young patients. And therein lies the conundrum.

According to statistics, child/ teen suicide is not uncommon. The American Academy of Child and Adolescent Psychiatry (AACAP) estimates that the struggle with depression causes over 500,000 young people to attempt suicide each year. There are approximately 2,000 deaths by suicide in the US each year, making it the third leading cause of death among 15-to 19-year-olds.

Hard Choices for Doctors

So, because of the risk of suicidal ideation, should physicians refrain from prescribing antidepressants for children altogether?

Absolutely not, says psychiatrist Sonja Randle, M.D., assistant professor of psychiatry at UT Medical School at Houston and director of the Child, Adolescent, and Family Clinic. "If kids with depression are not treated, there is a very high risk of deterioration.

"Coordination of care and follow-through are critical. Medication works for many, many kids," she says. "But it is even more effective when combined with cognitive behavioral therapy (CBT). The two of them together are better than either of them alone."

The National Association of Cognitive-Behavioral Therapists defines CBT as "a form of psychotherapy that emphasizes the important role of thinking in how we feel and what we do." The benefit, say practitioners, is that while one cannot change external factors such as other people, events, or situations, he can change the way he thinks about it.

Whether the prescriptions for children have increased or decreased depends upon which study you read. The New York Times commissioned Medco Health Solutions to determine the number of teens and children being prescribed antidepressants. Their finding? In the US, those prescriptions dropped 18 percent-largely, their report said, because of studies indicating the increase in suicidal thoughts in teens. On the other hand, the FDA information did not see a decline in prescriptions at all and said children ages 1 to17 still account for seven percent of the antidepressants prescribed.

Whatever the percentages, the fact remains that antidepressants are being prescribed for kids. Advocates felt vindicated by the outcome of the recently concluded Treatment for Adolescents with Depression Study (TADS). The outcomes were printed in the August 2004 issue of the Journal of the American Medical Association (JAMA ).

Combination Therapy Still Best Treatment

Funded by the National Institute of Mental Health, coordinated by the Duke Clinical Research Institute, and conducted in 13 academic and community centers in the United States, TADS evaluated the effectiveness of four treatments for teens with moderate to severe major depression:

• Clinical management with SSRIs (fluoxetine or Prozac) only
• CBT only
• Combination of SSRIs and CBT
• Clinical management with placebo

Clinical applications were straightforward and positive. Results showed that "71 percent of the patients who participated in TADS and were treated with both medication and therapy improved. Sixty percent improved using only medication." These are significant enough results to warrant the judicious use of antidepressants in kids, experts agree.

Parents and physician should closely monitor the child taking new medications or having med increases, Fant says, because the drugs can cause dramatic changes in mood and may be a warning signal.

"Parents are the first-line monitors. But being carefully observed by a physician can be problematic in today's healthcare system. The contact kids have with healthcare providers is all too often limited. If people need antidepressants, they really need to be seen by the people best trained to work with mental health issues. If their resources or insurance will not get them access to a psychiatrist or psychologist, a primary care provider can serve as the contact resource."

Fant says he cannot overemphasize that, "while the data indicates there is a small portion of kids at increased risk for this side effect (thoughts of suicide), a lot of lives would be lost without these medications.

"In our FDA panel recommendations, we felt strongly about not limiting the well-intentioned, well-informed, and well-trained healthcare providers' ability to prescribe antidepressants. But we wanted to make sure the warning was elevated so that parents were aware of the risks. It was critically important to get it right."

Last Updated: 11-29-2004

 

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