Black Box Warning

 
  Black Box Warning Yvette J. Brown | CWK Network
 
 
  The black box warning would have an impact. We may go backwards,”

– Dr. Elaine Mateo, child and adolescent psychologist


  Related Information What Parents Need To Know Resources

At 13, depression set in for Brandi Holtman. “My mom would think that I was upstairs getting ready for school, and I’d be in my closet crying,” she says.

At 14, Elora Radcliff was anxious and afraid. “I wanted to go in a corner and hide and not be around people,” she remembers.

Doctors prescribed antidepressants for both teens. Now, after a year of intense debate, the Food and Drug Administration says antidepressants are risky and may warrant a black box warning. “It’s basically a label on the medication that says, for example, this can cause an increased risk of suicidal ideation,” explains Dr. Elaine Mateo, a child and adolescent psychiatrist.

According to clinical trials of kids on antidepressants, nearly 3 percent of those studied experienced suicidal thoughts or behaviors, though none actually committed suicide. “The suicide rate has been decreasing, and I personally believe that it would have an impact — the black box warning would have an impact — we may go backwards,” says Dr. Mateo. In other words, she says, the suicide rate may go up if the warning frightens parents or doctors into not giving kids the medicine.

Experts say severely depressed kids are at a greater risk of suicide when they’re not medicated. “It’s been shown time and time again that the combination of psychotherapeutic and medication efforts is the most successful in bringing these very severe kids around,” says psychiatrist Dr. Dirk Huttenbach.

For Elora and Brandi, anti-depressant medicine was the help they needed. Elora says: “It helped me not be afraid. I’m not as nervous anymore, and, you know, I’m just happier all together.” As for Brandi, “It’s just like one day you are in a dark hole and the next day, you’re like, ‘Hey, I see the light.’”

By Amye Walters
CWK Network, Inc.

In the United States, depression is the most common mental health disorder. It affects 17 million people of all age groups, races and economic backgrounds each year, including as many as one-in-33 children and up to one-in-eight adolescents. Estimates of the number of children who have mental disorders range from 7.7 million to 12.8 million. Recent studies have shown that more than 20 percent of adolescents in the general population have emotional problems and one-third of adolescents attending psychiatry clinics suffer from depression. Mental health problems affect one-in-five young people at any given time. Studies indicate that 20 percent of children and adolescents may have a diagnosable disorder.

Depression isn’t something a child can snap out of. It’s not a bad mood that will eventually go away. Depression is a potentially serious illness that stems from a chemical imbalance in the brain. This treatable illness has definite symptoms and effective treatments. A thorough evaluation will take a couple of weeks to complete. Your child might spend two hourly sessions with a mental health provider and consult with other health care providers and even teachers. Seek help immediately if you notice your child exhibits:

  • Intense feelings of wanting to harm oneself.
  • Lethargy and disengagement that continue for a month.
  • with friends and at school that become commonplace.
 
By Amye Walters
CWK Network, Inc.

Don’t put off your child’s treatment. Early detection and diagnosis are key in treating children with depression. An estimated two-thirds of all young people with mental health problems are not getting the help they need. Of those who seek treatment for depression, 80 percent are treated successfully.

In March, the Food and Drug Administration issued a public health advisory urging parents, caregivers and families to monitor children taking antidepressants for signs depression is worsening and/or indications of suicidal thoughts. The FDA then asked the manufacturers of antidepressant drugs to include stronger warning labels about the need to monitor these patients. Recently, the FDA’s recommendations are for even more prominent and specific labels than previously recommended. Now an FDA advisory panel has urged the FDA to require that its strongest label — a black box — be placed in the inserts of antidepressants.

The FDA is not recommending that children stop taking antidepressants. In fact, suddenly discontinuing or changing the dose of a medication can cause more problems. Don’t stop giving your child antidepressant medications without the guidance of your child’s psychiatrist or doctor. Instead, talk to him or her about your concerns.

  • Antidepressants increase suicidal thinking in 2 to 3 percent of children and teens who take them.
  • Currently, Prozac is the only antidepressant with official FDA approval for use in children.
  • Doctors legally prescribe other antidepressants (like Zoloft, Celexa, Remeron, Wellbutrin, Luvox and Lexapro) for patients under 18.
  • Most drugs of all types prescribed for children are approved only for use by adults.
  • More people die from suicide than from homicide. For young people 15 to 24 years old, suicide is the third leading cause of death.
  • Because depressed children often are critical of themselves and their worlds, cognitive therapy is especially effective in helping change thought patterns. Cognitive therapy teaches children to look for connections between thoughts and actions and to challenge negative thoughts.
 

American Psychological Association
Atlanta Journal-Constitution
KidsHealth
National Mental Health Association
Smart Money
Suicide Awareness Voice of Education