Few Psychotropics Have Data for Use in Children

By Betsy Bates, Los Angeles Bureau
Originally published in Pediatric News 33(3):27, 1999

ANAHEIM, Calif. — Just because the Food and Drug Administration has approved a psychotropic drug for use in children doesn't mean that sufficient efficacy data exist to warrant pediatric labeling, Dr. Mark A. Riddle said at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

What's more, several psychotropic drugs that lack FDA approval for pediatric use actually do have substantive studies to validate their use in children, said Dr. Riddle, director of child and adolescent psychiatry at Johns Hopkins Hospital, Baltimore.

He and his colleagues last year published the first comprehensive review of efficacy studies of psychotropic medications in children, in the Psychiatric Clinics of North America: Annual of Drug Therapy (Philadephia: W.B. Saunders Co., 1998, pp. 269-85).

"The FDA has set minimal criteria to establish efficacy for adults… but not for children," they noted.

The researchers therefore established their own criteria for efficacy, including significant superiority to placebo in treating the primary outcome variable in at least 80 children in parallel-designed studies or 40 children in crossover studies.

Just 14 psychotropic drugs met those standards; only half of these medications have FDA-approved indications for use in children.

Eight drugs that did not meet Dr. Riddle's criteria for establishing efficacy in children have received pediatric labeling approval from the FDA.

New FDA incentives and regulations are expected to provide more information to physicians, who now prescribe for children on the basis of "clinical lore," extrapolation from adult data, or sketchy information from small, open-label trials, Dr. Riddle said.

FDA-Approved Pediatric Indications With Sufficient Data to Support Prescribing:

Methylphenidate (Ritalin) for attention-deficit hyperactivity disorder (ADHD) in children aged 6 years and older.
Dextroamphetamine (Dexedrine) for ADHD in children aged 6 years and older.
Pemoline (Cylert) for ADHD in children aged 6 years and older.
Clomipramine (Anafranil) for obsessive-compulsive disorder in children aged 10 years and older.
Fluvoxamine (Luvox) for obsessive-compulsive disorder in children aged 8 years and older.
Sertraline (Zoloft) for obsessive-compulsive disorder in children aged 6 years and older.
Pimozide (Orap) for Tourette's syndrome in patients who are aged 12 years and older.

FDA-Approved Pediatric Indications Without Sufficient Data to Support Prescribing:

Amphetamine salts (Adderall) for ADHD in children aged 3 years or older.
Dextroamphetamine (Dexedrine) for ADHD in children 3-5 years old.
Amitriptyline (Elavil) for depression in children 12 years and older.
Chlorpromazine (Thorazine) for pervasive developmental disorder, bipolar disorder, or hyperactivity in children aged 6 months or older.
Thioridazine (Mellaril) for pervasive developmental disorder, bipolar disorder, or hyperactivity in children who are aged 2 years or older.
Haloperidol (Haldol) for pervasive developmental disorder, bipolar disorder, or hyperactivity in children who are aged 3 years or older.
Lithium carbonate (Eskalith) for mania or lithium carbonate (Lithobid) for bipolar disorder in children who are 12 years old or older.
Diazepam (Valium) for anxiety in children aged 6 months or older.

Drugs With No FDA-Approved Pediatric Indication But With Sufficient Data to Support Prescribing:

Bupropion (Wellbutrin) for ADHD in children 6-12 years old.
Imipramine (Tofranil) for ADHD in children 6-12 years old.
Desipramine (Norpramin) for ADHD in children 7-13 years old.
Fluoxetine (Prozac) for depression in children 8-17 years old.
Lithium (Lithobid, Eskalith, Lithonate, Lithotabs) for "aggression" in hospitalized children aged 5-12 years.
Haloperidol (Haldol) for behavior problems in children with autism between the ages of 2 and 7 years.
Naltrexone (ReVia) for hyperactivity in autistic children 3-7 years old.