Antidepressants such as Prozac and Paxil do not raise the risk of suicide in children and teenagers, a group of pharmacologists said Wednesday in a preliminary report released amid a review by U.S. regulators.
Health officials in the United States and Britain are probing a possible link between antidepressants and suicide. A U.S. Food and Drug Administration advisory panel is scheduled to discuss the topic at a public meeting Feb. 2.
British drug safety experts said in December that most selective serotonin re-uptake inhibitor, or SSRI, antidepressants should not be used by children or adolescents.
Limited access to data
In response to the concerns, the American College of Neuropsychopharmacology, or ACNP, said it evaluated all published clinical trials on treatment of children with SSRIs. The group acknowledged, however, that it did not have access to ”a substantial amount of data” available to regulators and pharmaceutical companies.
The pharmacologists’ group said research it reviewed showed evidence of a connection was “weak.”
“We don’t see this as a compelling problem” based on current data, Dr. J. John Mann, chief of neuroscience at New York State Psychiatric Institute and co-chair of the ACNP task force that studied the issue, said at a news conference.
“The evidence, if anything, favors a positive effect,” Mann said, noting that those treated with the antidepressants were less likely to voice suicidal thoughts or exhibit suicidal behavior.
Drug makers say millions of patients have taken SSRIs without problems and that any suicidal thoughts are the result of depression rather than treatment.
The task force reviewed clinical trials involving more than 2,000 youth and found no significant increases in suicide attempts or suicidal thinking related to the antidepressants. No deaths by suicide were reported in the trials.
One shortcoming, however, was that people most likely to commit suicide generally were not included in the studies, Mann said.
Only Eli Lilly and Co.’s Prozac, also sold generically under the name fluoxetine, is approved by U.S. regulators for use in treating children with depression. But doctors may prescribe any approved drug for youth depression.
Other SSRIs include GlaxoSmithKline’s Paxil and Pfizer Inc.’s Zoloft.
ACNP is a nonprofit group that receives some unrestricted grants from pharmaceutical companies, but no industry funding was used to pay for the report, said Dr. Joseph Coyle, ACNP’s past president.
Thee UK’s Committee on Safety of Medicines last year advised that GlaxoSmithKline Plc’s Seroxat/Paxil and Wyeth’s Efexor/Effexor should not be prescribed to under-18s, after a review found they were associated with an increased rate of self-harm and suicidal thoughts.
Only fluoxetine, or Prozac, had been shown in clinical trials to have a favorable balance of risks and benefits for the treatment of major depressive disorder in under-18s, the UK committee said in a statement.