Antidepressant warnings make experts nervous
Web Posted: 02/03/2005 12:00 AM CST
San Antonio Express-News
Even as warning labels about the risk of suicidality in children and teens taking antidepressants are going on medication labels, a new study is showing that American suicide rates have dropped significantly since the introduction of Prozac and the newer antidepressants.
“Suicides are actually down since the new SSRIs (serotonin reuptake inhibitor drugs) started in 1988. Suicides have decreased a lot, dropping from the eighth to the 11th leading cause of death,” psychiatrist and lead investigator Julio Licinio said. “The biggest reason for suicide is depression, not antidepressant treatment. You have a much higher risk of suicide by not treating than by treating.”
Licinio, a professor of psychiatry and endocrinology at the David Geffen School of Medicne and a researcher at the University of California at Los Angeles Neuropsychiatric Institute, fears the Food and Drug Administration black box warning labels on antidepressants, issued after a storm of controversy last year, will keep some people from getting needed treatment.
Licinio and psychiatrist Ma-Ling Wong conducted an exhaustive review of the research on antidepressants and suicide published between 1960 and 2004. Their study, published in the February issue of Nature Reviews Drug Discovery, received no funding from drug companies.
In comments on Tuesday, Vera Hassner Sharav, a sharp critic of FDA regulators and drug companies and president of the New York-based Alliance for Human Research Protection, called Licinio’s causal connection between antidepressants and falling suicide rates “fallacious” and urged the drugs be used as a “last resort.”
“If you examine the Brady Bill (on handgun control) and when it was enacted (1993) with the restrictions on firearms, that’s when you see the reduction in homicides and suicides,” she said.
Under the FDA ruling, parents are supposed to receive a MedGuide about use of the prescription drugs. The black box warning label cautions that clinical trials showed children taking antidepressants had a 4 percent risk of suicidal thoughts and behavior versus 2 percent in those taking sugar pills.
Children and adolescents need to be monitored closely in the first nine days and up to the first month after going on antidepressants. That’s because antidepressants in the first few days are effective in reducing lethargy and raising a child’s energy level to act, but the drugs haven’t yet stopped the feelings of despair that can lead to suicidal behavior. Licinio said.
San Antonio adult and adolescent psychiatrist Randall V. Sellers said the black box warning won’t change the way psychiatrists prescribe. “But many family practitioners and pediatricians will hesitate to prescribe the medications. And most psychotropic drugs are prescribed by non-psychiatrists.”
Sellers also noted one fallout of the FDA warning and the need to closely monitor youths on antidepressants is that instead of seeing patients monthly, doctors will need to do weekly medication follow-ups. Some health insurance plans may not pay for all those visits.
As Licinio sees it, parents are right to approach antidepressants cautiously. “But people should not panic and stop taking the drugs. It’s like throwing the baby out with the bathwater.”