The FDA's decision to require strong warnings about risk of suicide in kids on antidepressants could have been misguided, new study finds.
A follow-up study to 2004 research, which had noted an increased risk of suicide among people taking certain antidepressants, particularly children and adolescents, has now reached a different conclusion. Contrary to the earlier results, the new study found that when the antidepressant prescribed is a good fit for the individual, there's a lower risk of suicide.
The new study's results were especially strong for adults and the elderly. Though there was no decrease in suicide risk among children and adolescents, there was also no increase.
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Depression is a mental illness characterized by persistent negative thoughts and feelings that interfere with one's enjoyment of daily life. Symptoms include sadness, loss of interest or pleasure in previously enjoyable activities, weight changes, sleep changes, loss of energy, feelings of worthlessness, and thoughts about death or suicide. It is often treated with medications which work on the neurotransmitters in the brain, particularly serotonin, norepinephrine, and dopamine. There are many types of antidepressant medications. A patient who is not responsive to one antidepressant may well improve when given another.
The 2004 study examined the clinical trial data that had been collected on two types of medications, selective serotonin reuptake inhibitors (SSRI) and selective norepinephrine reuptake inhibitors (SNRI). The results of the study prompted the Food and Drug Administration (FDA) to issue a black box warning, the most serious level of warning in prescription drug labeling, for the risk of suicides in children and adolescents being treated with antidepressants in 2004. The warning was extended to young adults ages 18 to 25 years in 2006.
The researchers in the current study performed a meta-analysis of 41 studies, reviewing the data on a total of 9,185 youths, adults, and geriatric patients who were treated with fluoxetine (Prozac is one common brand) and venlafaxine (Effexor) immediate (IR) and extended release (ER) preparations. They were interested in how effective the medications were on the symptoms of depression, and how the patient's suicidal thoughts and actions changed during the course of treatment. They specifically questioned whether the patients' suicidal thoughts and actions changed with modifications in the severity of depressive symptoms.
In all three age groups, treatment with fluoxetine and with venlafaxine IR and ER resulted in a statistically significant improvement in depressive symptoms when compared to treatment with placebo. The decline in depressive symptoms was also faster for patients treated with medication than control group patients. In the adult and geriatric patients who were treated with fluoxetine or venlafaxine, suicidal thoughts and behaviors decreased over time.
As the patients became less depressed, they had fewer suicidal thoughts and attempts. Although the youths who were treated with medication showed the same statistically significant decrease in depressive symptoms as the older populations, they did not show a decrease in suicidal ideation and actions.
"In kids, we don't see a harmful effect, but we do see a disassociation between the beneficial effects on depression and the potential beneficial effect on suicide," said the study's lead author, Dr. Robert Gibbons, a professor of medicine, health studies, and psychiatry, in a press release. "This raises continued questions about what's going on in children. Maybe children think about suicide in part because of depression, but also maybe due to other reasons not related to depression that are not affected by antidepressants."
A significant finding of this study, published in Archives of General Psychiatry, is the fact that suicide risk in youth, while not decreased by medication treatment, was also not increased. The newest analysis did not support the idea that there was an increased risk of suicide in children and adolescents taking fluoxetine, an SSRI. In explaining the difference in their findings, the researchers note that these original meta-analyses included fewer studies and the studies were of shorter term than the longitudinal data they analyzed.
Of note, this new study only reported on fluoxetine use in youth and did not investigate other antidepressant drugs, but the results were reassuring for this specific drug. Additionally, the study highlights the efficacy of medication treatment for depressive symptoms in all age groups. At this time, the original black box warning on potential suicidality in children and young adults treated with antidepressants remains in effect pending further study.
Gibbons told The Los Angeles Times that he hopes antidepressants will continue to be used appropriately for treatment of depression. "I hope that the warnings will not prevent depressed children and adults from getting treatment for depression," he said. "The greatest cause of suicide is untreated or undiagnosed depression. It's very important that this condition be recognized and appropriately treated and not discarded because doctors are afraid to be sued."
This article originally appeared on TheDoctorWillSeeYouNow.com, an Atlantic partner site.