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“Black box” labels ordered by the US Food and Drug Administration that warn of a greater risk of suicide from certain types of antidepressants may have had an effect opposite to that intended, says new research.
Comparing numbers of prescriptions of selective serotonin reuptake inhibitors (SSRIs) and reported suicides in the United States and the Netherlands, the researchers found that the rate of suicides among children and adolescents rose as numbers of prescriptions of SSRIs fell in 2003-4 (American Journal of Psychiatry 2007;164:1356-63 doi: 10.1176/appi.ajp.2007.07030454).
Numbers of suicides among Americans aged under 19 years rose by 14% from 2003 to 2004, the study says, the biggest annual increase since systematic recording began in 1979. The same year saw a 22% decrease in the number of SSRI prescriptions to this age group.
In the Netherlands the number of prescriptions of SSRIs fell just as fast, while the country experienced an even larger jump in the number of adolescent suicides, which rose by 49% from 2003 to 2005.
The American data show a startling reversal in the long term trend towards fewer suicides among young people. From 1990 to 2003 the overall suicide rate in the 10-24 age group had fallen 28.5%. Overall, 4599 Americans aged under 24 killed themselves in 2004, making it the third leading cause of death in this age group.
Thomas Laughren, director of the US Food and Drug Administration's division of psychiatry products, said in a statement: “FDA is obviously concerned about possible negative impacts of labelling changes but also feels a strong obligation to alert prescribers and patients to possible risks associated with the use of antidepressants. We will continue to monitor antidepressant use and suicide rates, and will take appropriate regulatory actions as new data become available.”
David Healy, professor of psychological medicine at Cardiff University, who is one of the people who first suggested a link between use of SSRIs and adolescent suicides, challenged the study's conclusions. He said that apparent changes in the rate of suicides may really reflect changes in coroners' verdicts.
Moreover, he said, “a drop in the script rate may involve primarily those on treatment chronically,” accompanied by a “constant or even increased rate of new patients being put on the drugs.” The beginning of treatment with SSRIs is a period that carries a high risk of suicide, he said.
He added: “There has also in the last two to three years been a huge switch from antidepressants to antipsychotics, as companies have marketed bipolar disorder. Antipsychotic ‘mood stabilisers' have just as great an increase in suicide risk as antidepressants, if not greater.” (See News doi: 10.1136/bmj.39335.363137.DB.)
Robert Gibbons, of the University of Illinois at Chicago, the study's lead author, disagreed, saying that his coauthor Robert Valuck, of the University of Colorado, published data in the August issue of the American Journal of Psychiatry (2007;164:1198-1205 doi: 10.1176/appi.ajp.2007.07010007) showing no increase in antipsychotic prescribing as SSRI prescribing fell.
He noted that in the Netherlands the rise in the number of suicides was proportionately greater than the decline in SSRI prescribing. “My conjecture is that patients deemed most at risk of suicide were those most likely to be taken off the drug, leading to a selection effect,” he said.