Anti-Depressant Use in Children and Adolescents
Parents of children or adolescent who suffer from major depression or severe anxiety are understandably concerned about the FDA’s “Black-Box Warning” regarding the use of anti-depressants in children under 18 years old. This handout attempt to address these concerns and explains a little more about the warning.
The Back Story
In October of 2004, the FDA ordered pharmaceutical companies to add a “Black-Box Warning” to anti-depressant advertisements, package inserts and information sheets that are given to patients and doctors. A Black-Box Warning is a statement in prominent, bold-faced type, framed by a black border. The Black-Box Warning regarding anti-depressants is a statement of potential increased risk of suicidality in the first 4-8 weeks of taking the medication. Two committees charged with examining the occurrence of suicidality (suicidal thinking, behavior or attempt) in teens with major depressive disorder had recently concluded that there was a causal link between the newer anti-depressants and pediatric suicidality.
An intense controversy quickly followed within the medical profession and society at large. Pediatric associations in many countries disagreed with the FDA’s recommendations, as did the American Association of Child Psychiatry. Many experts outside the FDA have questioned the data used to make its decision. As we’ll discuss further on, there’s more here than meets the eye.
Suicide & Depression in Older Children & Teens
Suicide is the second leading cause of death in Oregon for people aged 5-34. Research has consistently found that between 15-20 percent of high-school students at some point have considered suicide and that 3 percent had made an injurious suicide attempt. One in five adolescents will suffer a major depressive disorder at one time before high-school graduation.
What are the “Newer” Anti-Depressants?
The “newer” anti-depressants targeted by the FDA are called selective serotonin reputable inhibitors (SSRI’s). These include Prozac (fluoxetine), Paxil (Paroxetine), Zoloft (Sertraline), Celexa (Citalopram) and others. These anti-depressants have far fewer side effects than earlier generations of anti-depressants. Approximately 1 in 100 pre-teens or teens have been prescribed an SSRI at some point. SSRI’s are generally used to treat major depression or severe anxiety in addition to mental health counseling. About 60 percent of the prescriptions for SSRI’s are written by psychiatrists, 20 percent by pediatricians and 20 percent by family physicians.
The “Black-Box Warning” does not prohibit the use of SSRI’s in pediatric patients, but warns of the potential for increased risk of suicidality, particularly when starting treatment. Physicians and parents are warned to more closely monitor the child or teen during the first 4-8 weeks of treatment, including scheduling frequent office visits and never permitting the teen to be alone for extended periods of time. But is the medication increasing suicidality or is there another phenomenon going on? Do adolescents perhaps get frustrated that the medication takes 4-6 weeks to reach full effect and doesn’t make them feel immediately better? Do their suicidal thoughts just measure the progress of their depression? Does the medication make them have more energy so they are more likely to act on their underlying thoughts? We don’t fully know the answers to these questions.
Short-term placebo controlled trials of more than 4400 adolescents demonstrated an overall small increased risk of suicidal thoughts or behavior in the first few weeks of initiating therapy. However, only 7 of 24 studies showed this effect. In general, for every 143 youths treated for depression, 1 had an episode of suicidal thought or activity. There were no completed suicides among the patients studies. The researchers concluded that the benefits of anti-depressants far outweighed the risks.
The Bottom Line
The “Black-Box Warning” is the strongest caution from the FDA to prescribers and patients regarding possible effects, but it does not prohibit using SSRI’s in children. Anti-depressant medication is an important treatment for the appropriate pediatric patient but doesn’t substitute for mental health counseling. The best treatment for major depression and anxiety is both counseling, such as cognitive-behavioral therapy +/- medication. The two should always go hand-in-hand. Large legitimate studies have repeatedly demonstrated that for every 3 adolescent patients treated with an SSRI for major depression, one will improve from medication, one will improve because of the placebo effect and one will not improve. Stated differently, there is a significant subset of adolescents for whom medication is very helpful and an equally significant number of youths for whom the placebo effect is strong and equally beneficial.
If your child or teen suffers from major depression or severe anxiety and counseling has not significantly improved their symptoms, treatment with an SSRI should be considered. Taking the FDA’s concerns seriously, we will partner with you in monitoring your child closely for the first 4-8 weeks on medication. We have specific chart forms that aid in the monitoring process and we will want to see your child at least once in the first four weeks of therapy.
We urge parents to understand that a child suffering from major depression despite mental health counseling is already at high risk for suicidal thoughts or attempts. Choosing not to use an SSRI, out of fear of the FDA’s “Black-Box Warning” quite likely places your child at higher risk of suicidality than the small increased risk of suicidal thoughts caused by the medication.