2004 FDA Warnings of Suicide Risk May Have Increased Suicide Attempts: Study

In 2003 and 2004, the FDA issued warnings that adolescents who took antidepressants classified as selective serotonin reuptake inhibitors (SSRI) were at increased risk of “suicidality,” which includes both suicidal ideation, or thoughts of suicide, and actual attempts. The warnings were widely reported in the media in the United States and around the world. In a study published in the journal BMJ, the authors examined the use of antidepressants and suicidal behavior before and after issuance of the warnings. They found that the use of antidepressants by adolescents and young adults dropped sharply after the warnings and the attendant publicity, while attempted suicides rose a bit. The investigators expressed concern that the warnings and the oversimplification in the news coverage may have had the unintended consequence of increasing suicide attempts by individuals who went without treatment because of the warnings.


The investigators used a database maintained by the U.S. Mental Health Research Network, whose members comprise 11 health maintenance organizations (HMOs) dispersed throughout the country. The patients covered by the plans included about 1.1 million between the ages of 10 and 17 (adolescents), 1.4 million young adults between the ages of 18 and 29, and 5 million adults between 30 and 64. The investigators measured three variables—use of antidepressants, suicide attempts, and completed suicides—for each quarter from January 2000 through December 2010. The frequency during the pre-warning period from January 2000 through September 2003 was compared to the transition period, from October 2003 through December 2004, and the post-warning period, from January 2005 through December 2010. To measure suicide attempts, the investigators used poisoning with psychotropic drugs.


Before the warnings, the use of antidepressants by adolescents had been growing at a stable rate. In the second year after the warnings, antidepressant use in this age group dropped by 31.0 percent relatively; the absolute decrease was 0.7 percentage points, or 696 per 100,000 patients. Poisoning with psychotropic drugs increased relatively by 21.7 percent; the absolute increase was 0.002 percentage points, or two people in 100,000. Poisoning with all drugs grew by 13.9 percent. The authors found the increase in psychotropic drug poisoning statistically significant among males.

Similar changes occurred among young adults. Use of antidepressants dropped relatively by 24.3 percent (an absolute decrease of 1.22 percentage points), while poisoning with psychotropic drugs grew by 33.7 percent (an absolute increase of 0.004 percentage points, or four people in 100,000). The authors did not find a significant change in completed suicides in either group.


In both groups, the number of individuals with a diagnosis of depression decreased, and there was no evidence of an increased use of other therapies for depression. Therefore, the authors found, fewer people were treated for depression, and they believe that it is likely that the increase in suicide attempts reflected the growth in untreated cases of depression.