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Mental Health and Illness - Prescribing Psychoactive Medication To Children

medications approved safety nimh

The NIMH released Treatment of Children with Mental Disorders (2004,, a publication aimed at parents of children with a range of mental disorders. The NIMH acknowledged public concern that psychotropic medication is being prescribed to very young children and that the safety and efficacy of most psychotropic medications have not yet been established. Several widely used drugs have not received FDA approval for use in young children simply because there are not enough data to support their use.

The data are lacking because historically there were ethical concerns about involving children in clinical trials to determine not only the most effective treatments but also proper dosage, potential side effects, and the long-term effects of drug use on learning and development. Policies about research involving children affect the FDA approval process and recommendations for use. For example, methylphenidate is approved for use in children age six and older, but its use was not evaluated in TABLE 8.6 Medications chart for children and adolescents "Medications Chart," in Treatment of Children with Mental Disorders, National Institute of Mental Health, 2004, January 19, 2006)children younger than age six. In contrast, dextromethamphetamine received approval for use in children as young as three because by the time approval was sought, study guidelines permitted participation of younger children. Table 8.6 lists the brand and generic names of medications in four major classes of drugs used to treat mental disorders in children and adolescents and indicates the ages at which drug use is approved.

Medications chart for children and adolescents
Brand name Generic name Approved age
*Due to its potential for serious side effects affecting the liver, Cylert should not ordinarily be considered as first line drug therapy for ADHD (attention deficit hyperactivity disorder).
Note: OCD=Obsessive-compulsive disorder. SSRI = Selective serotonin reuptake inhibitor
SOURCE: "Medications Chart," in Treatment of Children with Mental Disorders, National Institute of Mental Health, 2004, January 19, 2006)
Stimulant medications
Adderall Amphetamines 3 and older
Concerta Methylphenidate 6 and older
Cylert* Pemoline 6 and older
Dexedrine Dextroamphetamine 3 and older
Dextrostat Dextroamphetamine 3 and older
Ritalin Methylophenidate 6 and older
Antidepressant and antianxiety medications
Anafranil Clomipramine (for OCD) 10 and older
BuSpar Buspirone 18 and older
Effexor Venlafaxine 18 and older
Luvox (SSRI) Fluvoxamine (for OCD) 8 and older
Paxil (SSRI) Paroxetine 18 and older
Prozac (SSRI) Fluoxetine 18 and older
Serzone (SSRI) Nefazodone 18 and older
Sinequan Doxepin 12 and older
Tofranil Imipramine (for bed-wetting) 6 and older
Wellbutrin Bupropion 18 and older
Zoloft (SSRI) Sertraline (for OCD) 6 and older
Antipsychotic medications
Clozaril (atypical) Clozapine 18 and older
Haldol Haloperidol 3 and older
Risperdal (atypical) Risperidone 18 and older
Seroquel (atypica) Quetiapine 18 and older
  (generic only) Thioridazine 2 and older
Zyprexa (atypica) Olanzapine 18 and older
Orap Pimozide 12 and older (for Tourette's syndrome). Data for age 2 and older indicate similar safety profile.
Modd stabilizing medications
Cibality-S Lithium citrate 12 and older
Depakote Divalproex sodium (for seizures) 2 and older
Eskalith Lithium carbonate 12 and older
Lithobid Lithium carbonate 12 and older
Tegretol Carbamazepine (for serizures) Any age

Because the FDA approval process often requires years of research to demonstrate safety and efficacy, and practitioners are eager to provide symptom relief for severely troubled children, many recommend off-label use of medications. Off-label treatment may involve use of a medication that has not yet received official FDA approval for use in children or the use of a drug the FDA has approved for children to treat a specific condition for which its use has not been approved. The HHS in Report of the Surgeon General's Conference on Children's Mental Health: National Action Agenda (updated April 2004, found that the majority of all drugs approved by the FDA for adult use have not been approved for use in children. As such, they are prescribed off-label when used in pediatric and adolescent medicine. The NIMH observes that some off-label use is supported by data from well-controlled studies but cautions that other off-label prescribing, particularly to very young children whose responses to these drugs have not been scrutinized, should be performed prudently.

The Surgeon General's report found strong support for the safety and efficacy of several classes of agents for several conditions, specifically SSRIs for childhood/ adolescent obsessive-compulsive disorder and psychostimulants for ADHD. The report lamented the lack of information about the safety and efficacy of other psychotropics and urged researchers to produce data for SSRIs, mood stabilizers, and new antipsychotics, because these medications appear to be high on the growing list of psychotropic medications used to treat children and adolescents. Table 8.7 offers letter grades that rate the short-and long-term safety and efficacy of eight classes of drugs used to treat specific mental disorders in children.

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over 6 years ago

I can't add a web cite above. I would like to reference this material in a presentation I am putting together for a psy480 class. The presentation will be used for academic purposes only.