CHAPEL HILL, N.C. -- A majority of family physicians and pediatricians are treating children with Prozac-type drugs for mild to moderate mental illness, despite a lack of scientific evidence to support their safety and effectiveness in youngsters, according to a University of North Carolina at Chapel Hill study.
A report of the findings, presented Saturday, May 1, at the Pediatrics Academic Societies Annual Conference in San Francisco, focuses on the serotonin selective reuptake inhibitors (SSRIs), the newest class of antidepressant drugs. Currently approved by the Food and Drug Administration for patients over 18 years of age, SSRIs have been increasingly prescribed for children since 1992.
Researchers led by Dr. Jerry L. Rushton, a pediatrician and Robert Wood Johnson Clinical Scholar at the University of North Carolina at Chapel Hill, note that "despite a paucity of safety and effectiveness data," over 500,000 prescriptions for SSRIs are written for children and adolescents each year.
"Our survey data suggest that despite a lack of research support, adequate training and comfort with the management of depression, SSRIs are gaining physician acceptance and becoming incorporated into primary care practice," Rushton says.
According to survey responses from nearly 600 family physicians and pediatricians, 72 percent acknowledged having prescribed an SSRI for a patient younger than 18 years of age. Just 8 percent reported having received adequate training in the management of childhood depression, and 16 percent "reported feeling comfortable" with the care of depressed children.
"We found that SSRIs were the most common type of medication used for childhood depression, comprising 69 percent of all primary care prescriptions," Rushton says. He notes that 67 percent of respondents said they had written SSRI prescriptions for children and young adolescents with mild to moderate depression.
In addition, 57 percent acknowledged having prescribed an SSRI for a diagnosis other than depression in a child younger than 18 years of age. These included children diagnosed with attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), aggression/conduct disorder, and enuresis (bed-wetting).
As Rushton and his colleagues point out, these are problems for which the evidence is at best scant to support SSRI safety and effectiveness in children. Except for OCD, such problems are not federally approved indications for prescribing SSRIs to adults.
"Anecdotally, we hear of widespread use of SSRIs for possibly questionable indications," Rushton says. He compares this to the controversy over the use of Ritalin for ADHD.
"We wondered if a similar process was starting with attention deficit and Prozac, the most commonly prescribed SSRI in children. Thirty-six percent of physicians have used SSRIs for ADHD. What does that mean -- are these children being properly diagnosed, and what are the outcomes of treatment with these drugs?"
Should physicians have the freedom to prescribe "off-label," which, in the case of SSRIs, means children younger than 18 years of age? "I think they should," Rushton says. "But, as with any therapy, they should discuss with their patients what the risks and benefits are."
As the researcher points out, the long-term effects of many "psychoactive" drugs, including SSRIs, on the developing central nervous system are unknown. But SSRIs have a variety of documented side effects in adolescents and children including sleep disturbances and behavioral changes. Moreover, no clear age and dosage guidelines exist for these medications and prescription practices are based on studies in adults and anecdotal experience with children.
"I think these medications are starting to show promise. We don't have all the data and guidelines, but it stands to reason that SSRIs should be used for childhood depression. They probably are safer than the older tricyclic antidepressants. However, they should be used with caution and monitored closely, not used haphazardly for transient symptoms - not for school problems nor nebulous behavioral problems," Rushton says.
Finally, the new survey also highlighted several factors that may influence SSRI prescribing practices for children: physician specialty, degree of comfort with the management of childhood depression, and availability of referral to mental health specialists.
Even after taking demographic differences into account (for example, rural vs. urban), family physicians were six times as likely as pediatricians to have prescribed an SSRI for depression and were twice as likely to have done so for other indications. Physicians comfortable with management of depression and those who had limited referral availability to mental health specialists also were significantly more likely to prescribe SSRIs.
"There is a fear that these medications will supplant or replace other multi-modal therapies - counseling, family intervention, behavioral therapies, which at least in adults and adolescents have been shown effective," Rushton says. "Primary care physicians should work with psychiatrists and include psychotherapy or counseling in their management program."
Note to media: From May 1-4, Rushton can be reached in San Francisco at 415-905-1001, 415-905-1002 or 415-905-1003. After May 4, he can be reached at 919-966-3716 or email rushton@med.unc.edu. UNC-CH School of Medicine media contact is Lynn Wooten, 919-966-6046, or email LWooten@unch.unc.edu.