A Note to Parents
There has been public concern over reports that very young children are
being prescribed psychotropic medications. The studies to date are
incomplete, and much more needs to be learned about young children who are
treated with medications for all kinds of illnesses. In the field of
mental health, new studies are needed to tell us what the best treatments
are for children with emotional and behavioral disturbances.
Children are in a state of rapid change and growth during their
developmental years. Diagnosis and treatment of mental disorders must be
viewed with these changes in mind. While some problems are short-lived and
don't need treatment, others are persistent and very serious, and parents
should seek professional help for their children.
Not long ago, it was thought that many brain disorders such as anxiety
disorders, depression, and bipolar disorder began only after childhood. We
now know they can begin in early childhood. An estimated 1 in 10 children
and adolescents in the United States suffer from mental illness severe
enough to cause some level of impairment. Fewer than 1 in 5 of these ill
children receives treatment. Perhaps the most studied, diagnosed, and
treated childhood-onset mental disorder is attention deficit hyperactivity
disorder (ADHD), but even with this disorder there is a need for further
research in very young children. A series of questions we are frequently
asked regarding the treatment of children with mental disorders follow.
Questions and Answers
Q: What should I do if I am concerned about mental, behavioral,
or emotional symptoms in my young child?
A: Talk to your child's doctor. Ask questions and find out everything
you can about the behavior or symptoms that worry you. Every child is
different and even normal development varies from child to child. Sensory
processing, language, and motor skills are developing during early
childhood, as well as the ability to relate to parents and to socialize
with caregivers and other children. If your child is in daycare or
preschool, ask the caretaker or teacher if your child has been showing any
worrisome changes in behavior, and discuss this with the doctor.
Q: How do I know if my child's problems are serious?
A: Many everyday stresses cause changes in behavior. The birth of a
sibling may cause a child to temporarily act much younger. It is important
to recognize such behavior changes, but also to differentiate them from
signs of more serious problems. Problems deserve attention when they are
severe, persistent, and impact on daily activities. Seek help for your
child if you observe problems such as changes in appetite or sleep, social
withdrawal, or fearfulness; behavior that seems to slip back to an earlier
phase such as bedwetting; signs of distress such as sadness or
tearfulness; self-destructive behavior such as head banging; or a tendency
to have frequent injuries. In addition, it is essential to review the
development of your child, any important medical problem he/she might have
had, family history of mental disorders, and physical and psychological
traumas or situations that may cause stress.
Q: Whom should I consult to help my child?
A: First, consult your child's doctor. Ask for a complete health
examination of your child. Describe the behaviors that worry you. Ask
whether your child needs further evaluation by a specialist in child
behavioral problems. Such specialists may include psychiatrists,
psychologists, social workers, and behavioral therapists. Educators may
also be needed to help your child.
Q: How are mental disorders diagnosed in young children?
A: Similar to adults, disorders are diagnosed by observing signs and
symptoms. A skilled professional will consider these signs and symptoms in
the context of the child's developmental level, social and physical
environment, and reports from parents and other caretakers or teachers,
and an assessment will be made according to criteria established by
experts. Very young children often cannot express their thoughts and
feelings, which makes diagnosis a challenging task. The signs of a mental
disorder in a young child may be quite different from those of an older
child or an adult.
Q: Won't my child get better with time?
A: Sometimes yes, but in other cases children need professional help.
Problems that are severe, persistent, and impact on daily activities
should be brought to the attention of the child's doctor. Great care
should be taken to help a child who is suffering, because mental,
behavioral, or emotional disorders can affect the way the child grows up.
Q: Are there situations in which it is advisable to use
psychotropic medications in young children?
A: Psychotropic medications may be prescribed for young children with
mental, behavioral, or emotional symptoms when the potential benefits of
treatment outweigh the risks. Some problems are so severe and persistent
that they would have serious negative consequences for the child if
untreated, and psychosocial interventions may not always be effective by
themselves. The safety and efficacy of most psychotropic medications have
not yet been studied in young children. As a parent, you will want to ask
many questions and evaluate with your doctor the risks of starting and
continuing your child on these medications. Learn everything you can about
the medications prescribed for your child, including potential side
effects. Learn which side effects are tolerable and which ones are
threatening. In addition, learn and keep in mind the goals of a particular
treatment (e.g., change in specific behaviors). Combining multiple
psychotropic medications should be avoided in very young children unless
absolutely necessary.
Q: Does medication affect young children differently from older
children or adults?
A: Yes. Young children's bodies handle medications differently than
older individuals and this has implications for dosage. The brains of
young children are in a state of very rapid development, and animal
studies have shown that the developing neurotransmitter systems can be
very sensitive to medications. A great deal of research is still needed to
determine the effects and benefits of medications in children of all ages.
Yet it is important to remember that serious untreated mental disorders
themselves negatively impact brain development.
Q: If my preschool child receives a diagnosis of a mental
disorder, does this mean that medications have to be used?
A: No. Psychotropic medications are not generally the first option for
a preschool child with a mental disorder. The first goal is to understand
the factors that may be contributing to the condition. The child's own
physical and emotional state is key, but many other factors such as
parental stress or a changing family environment may influence the child's
symptoms. Certain psychosocial treatments may be as effective as
medication.
Q: How should medication be included in an overall treatment
plan?
A: When medication is used, it should not be the only strategy. There
are other services that you may want to investigate for your child. Family
support services, educational classes, behavior management techniques, as
well as family therapy and other approaches should be considered. If
medication is prescribed, it should be monitored and evaluated regularly.
Q: Which mental disorders are seen in children?
A: Mental disorders with possible onset in childhood include: anxiety
disorders, attention deficit and disruptive behavior disorders, autism and
other pervasive developmental disorders, eating disorders (e.g., anorexia
nervosa), mood disorders (e.g., major depression, bipolar disorder),
schizophrenia, and tic disorders. Under some circumstances, bedwetting and
soiling may be symptoms of a mental disorder.
Q: Can events such as a death in the family, illness in a parent,
onset of poverty, or divorce cause symptoms?
A: Yes. When a tragedy occurs or some extreme stress hits, every member
of a family is affected, even the youngest ones. This should also be
considered when evaluating mental, emotional, or behavioral symptoms in a
child.
Q: What difference does it make if a medication is specifically
approved for use in children or not?
A: Approval of a medication by the U.S. Food and Drug Administration
(FDA) means that adequate data have been provided to the FDA by the drug
manufacturer to show safety and efficacy for a particular therapy in a
particular population. Based on the data, a label indication for the drug
is established that includes proper dosage, potential side effects, and
approved age. Doctors prescribe medications as they feel appropriate even
if those uses are not included in the labeling. Although in some cases
there is extensive clinical experience in using medications for children
or adolescents, in many cases there is not. Everyone agrees that more
studies in children are needed if we are to know the appropriate dosages,
how a drug works in children, and what effects there are on learning and
development.
Q: What does "off-label" use of a medication mean?
A: Many medications that are on the market have not been officially
approved by the FDA for use in children. Treatment of children with these
medications is called "off-label" use. For some medications, the
off-label use is supported by data from well-conducted studies in
children. For instance, some antidepressant medications have been shown to
be effective in children and adolescents with depression. For other
medications, there are no controlled studies in children, but only
isolated clinical reports. In particular, the use of psychotropic
medications in preschoolers has not been adequately studied and must be
considered very carefully by balancing severity of symptoms, degree of
impairment, and potential benefits and risks of treatment.
Q: Why haven't many medications been tested in children?
A: In the past, medications were not studied in children because of
ethical concerns about involving children in clinical trials. However,
this created a new problem: lack of knowledge about the best treatments
for children. In clinical settings where children are suffering from
mental or behavioral disorders, medications are being prescribed at
increasingly early ages. The FDA has been urging that products be
appropriately studied in children and has offered incentives to drug
manufacturers to carry out such testing. The NIH and the FDA are examining
the issue of medication research in children and are developing new
research approaches.
Q: Does the FDA approve medications for different age groups
among children?
A: Yes. However, this is based on the data provided to the FDA by the
drug manufacturer and the policies in effect at the time of approval. For
example, Ritalin® is approved for children age 6 and older, whereas
Dexedrine® is approved for children as young as 3. When Ritalin® was
tested for efficacy by its manufacturer, only children age 6 and above
were involved; therefore, age 6 was approved as the lower age limit for
Ritalin®.
Q: What medications are used for which kinds of childhood mental
disorders?
A: There are several major categories of psychotropic medications:
stimulants, antidepressants, antianxiety agents, antipsychotics, and mood
stabilizers. For medications approved by FDA for use in children, dosages
depend on body weight and age.
Stimulant Medications: There are four stimulant medications that
are approved for use in the treatment of attention deficit hyperactivity
disorder (ADHD), the most common behavioral disorder of childhood. These
medications have all been extensively studied and are specifically labeled
for pediatric use. Children with ADHD exhibit such symptoms as short
attention span, excessive activity, and impulsivity that cause substantial
impairment in functioning. Stimulant medication should be prescribed only
after a careful evaluation to establish the diagnosis of ADHD and to rule
out other disorders or conditions. Medication treatment should be
administered and monitored in the context of the overall needs of the
child and family, and consideration should be given to combining it with
behavioral therapy. If the child is of school age, collaboration with
teachers is essential.
Antidepressant and Antianxiety Medications: These medications
follow the stimulant medications in prevalence among children and
adolescents. They are used for depression, a disorder recognized only in
the last twenty years as a problem for children, and for anxiety
disorders, including obsessive-compulsive disorder (OCD). The medications
most widely prescribed for these disorders are the selective serotonin
reuptake inhibitors (SSRIs).
In the human brain, there are many "neurotransmitters" that
affect the way we think, feel, and act. Three of these neurotransmitters
that antidepressants influence are serotonin, dopamine, and
norepinephrine. SSRIs affect mainly serotonin and have been found to be
effective in treating depression and anxiety without as many side effects
as some older antidepressants. The table shows the most commonly
prescribed medications for children with depression or anxiety disorders
(including OCD).
Antipsychotic Medications: These medications are used to treat
children with schizophrenia, bipolar disorder, autism, Tourette's
syndrome, and severe conduct disorders. Some of the older antipsychotic
medications have specific indications and dose guidelines for children.
Some of the newer "atypical" antipsychotics, which have fewer
side effects, are also being used for children. Such use requires close
monitoring for side effects.
Mood Stabilizing Medications: These medications are used to
treat bipolar disorder (manic-depressive illness). However, because there
is very limited data on the safety and efficacy of most mood stabilizers
in youth, treatment of children and adolescents is based mainly on
experience with adults. The most typically used mood stabilizers are
lithium and valproate (Depakote®), which are often very effective for
controlling mania and preventing recurrences of manic and depressive
episodes in adults. Research on the effectiveness of these and other
medications in children and adolescents with bipolar disorder is ongoing.
In addition, studies are investigating various forms of psychotherapy,
including cognitive-behavioral therapy, to complement medication treatment
for this illness in young people.
Effective treatment depends on appropriate diagnosis of bipolar
disorder in children and adolescents. There is some evidence that using
antidepressant medication to treat depression in a person who has bipolar
disorder may induce manic symptoms if it is taken without a mood
stabilizer. In addition, using stimulant medications to treat co-occurring
ADHD or ADHD-like symptoms in a child with bipolar disorder may worsen
manic symptoms. While it can be hard to determine which young patients
will become manic, there is a greater likelihood among children and
adolescents who have a family history of bipolar disorder. If manic
symptoms develop or markedly worsen during antidepressant or stimulant
use, a physician should be consulted immediately, and diagnosis and
treatment for bipolar disorder should be considered.
Stimulant Medications
|
Brand Name
|
Generic Name
|
Approved Age
|
|
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
|
methylphenidate
|
6 and older
|
* Due to its potential for serious side effects affecting the liver,
Cylert should not ordinarily be considered as first line drug therapy for
ADHD.
Antidepressant and Antianxiety
Medications
|
Brand Name
|
Generic Name
|
Approved Age
|
|
Anafranil
|
clomipramine
|
10 and older (for OCD)
|
|
BuSpar
|
buspirone
|
18 and older
|
|
Effexor
|
venlafaxine
|
18 and older
|
|
Luvox (SSRI)
|
fluvoxamine
|
8 and older (for OCD)
|
|
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
|
6 and older (for bedwetting)
|
|
Wellbutrin
|
bupropion
|
18 and older
|
|
Zoloft (SSRI)
|
sertraline
|
6 and older (for OCD)
|
Antipsychotic Medications
|
Brand Name
|
Generic Name
|
Approved Age
|
|
Clozaril (atypical)
|
clozapine
|
18 and older
|
|
Haldol
|
haloperidol
|
3 and older
|
|
Risperdal (atypical)
|
risperidone
|
18 and older
|
|
Seroquel (atypical)
|
quetiapine
|
18 and older
|
|
(generic only)
|
thioridazine
|
2 and older
|
|
Zyprexa (atypical)
|
olanzapine
|
18 and older
|
|
Orap
|
pimozide
|
12 and older (for Tourette’s syndrome).
Data for age 2 and older indicate similar safety profile.
|
Mood Stabilizing Medications
|
Brand Name
|
Generic Name
|
Approved Age
|
|
Cibalith-S
|
lithium citrate
|
12 and older
|
|
Depakote
|
divalproex sodium
|
2 and older (for seizures)
|
|
Eskalith
|
lithium carbonate
|
12 and older
|
|
Lithobid
|
lithium carbonate
|
12 and older
|
|
Tegretol
|
carbamazepine
|
any age (for seizures)
|
Report provided by the National Institute of Mental Health,
September 2000.
|