Public concern over reports that very young children are being prescribed medication.

A Note to Parents				to investigate for your child. Family support services,
There has been public concern over reports that very				educational classes, behavior management techniques,
young children are being prescribed psychotropic				as well as family therapy and other approaches should
medications. The studies to date are incomplete, and				be considered. If medication is prescribed, it should be
much more needs to be learned about young children				monitored and evaluated regularly.
who are treated with medications for all kinds of				Q: What medications are used for which kinds of
illnesses. In the field of mental health, new studies are				childhood mental disorders?
needed to tell us what the best treatments are for				A: There are several major categories of psychotropic
children with emotional and behavioral disturbances.				medications: stimulants, antidepressants, antianxiety
Children are in a state of rapid change and growth				agents, antipsychotics, and mood stabilizers. For
during their developmental years. Diagnosis and				medications approved by the FDA for use in children,
treatment of mental disorders must be viewed with				dosages depend on body weight and age. The
these changes in mind. While some problems are				Medications Chart in this booklet shows the most
short-lived and don't need treatment, others are				commonly prescribed medications for children with
persistent and very serious, and parents should seek				mood or anxiety disorders (including OCD).
professional help for their children.				Stimulant Medications: There are four stimulant
Not long ago, it was thought that many brain disorders				medications that are approved for use in the
such as anxiety disorders, depression, and bipolar				treatment of attention deficit hyperactivity disorder
disorder began only after childhood.				(ADHD), the most common behavioral disorder of
We now know they can begin in early childhood. An				childhood. These medications have all been extensively
estimated 1 in 10 children and adolescents in the United				studied and are specifically labeled for pediatric use.
States suffers from mental illness severe enough to				Children with ADHD exhibit such symptoms as short
cause some level of impairment. Fewer than one in				attention span, excessive activity, and impulsivity that
five of these ill children receives treatment. Perhaps				cause substantial impairment in functioning. Stimulant
the most studied, diagnosed, and treated				medication should be prescribed only after a careful
childhood-onset mental disorder is attention deficit				evaluation to establish the diagnosis of ADHD and to
hyperactivity disorder (ADHD), but even with this				rule out other disorders or conditions. Medication
disorder there is a need for further research in very				treatment should be administered and monitored in the
young children.				context of the overall needs of the child and family,
This booklet contains answers to frequently asked				and consideration should be given to combining it with
questions regarding the treatment of children with				behavioral therapy. If the child is of school age,
mental disorders.				collaboration with teachers is essential.
Questions and Answers				Antidepressant and Antianxiety Medications: These
Q: What should I do if I am concerned about mental,				medications follow the stimulant medications in
behavioral, or emotional symptoms in my young child?				prevalence among children and adolescents. They are
A: Talk to your child's doctor. Ask questions and find				used for depression, a disorder recognized only in the
out everything you can about the behavior or				last 20 years as a problem for children, and for anxiety
symptoms that worry you. Every child is different and				disorders, including obsessive-compulsive disorder
even normal development varies from child to child.				(OCD). The medications most widely prescribed for
Sensory processing, language, and motor skills are				these disorders are the selective serotonin reuptake
developing during early childhood, as well as the ability				inhibitors (the SSRIs).
to relate to parents and to socialize with caregivers				In the human brain, there are many "neurotransmitters"
and other children. If your child is in daycare or				that affect the way we think, feel, and act. Three of
preschool, ask the caretaker or teacher if your child				these neurotransmitters that antidepressants influence
has been showing any worrisome changes in behavior,				are serotonin, dopamine, and norepinephrine. SSRIs
and discuss this with your child's doctor.				affect mainly serotonin and have been found to be
Q: How do I know if my child's problems are serious?				effective in treating depression and anxiety without as
A: Many everyday stresses cause changes in				many side effects as some older antidepressants.
behavior. The birth of a sibling may cause a child to				Antipsychotic Medications: These medications are
temporarily act much younger. It is important to				used to treat children with schizophrenia, bipolar
recognize such behavior changes, but also to				disorder, autism, Tourette's syndrome, and severe
differentiate them from signs of more serious				conduct disorders. Some of the older antipsychotic
problems. Problems deserve attention when they are				medications have specific indications and dose
severe, persistent, and impact on daily activities. Seek				guidelines for children. Some of the newer "atypical"
help for your child if you observe problems such as				antipsychotics, which have fewer side effects, are
changes in appetite or sleep, social withdrawal, or				also being used for children. Such use requires close
fearfulness; behavior that seems to slip back to an				monitoring for side effects.
earlier phase such as bed-wetting; signs of distress				Mood Stabilizing Medications: These medications are
such as sadness or tearfulness; self-destructive				used to treat bipolar disorder (manic-depressive illness).
behavior such as head banging; or a tendency to have				However, because there is very limited data on the
frequent injuries. In addition, it is essential to review the				safety and efficacy of most mood stabilizers in youth,
development of your child, any important medical				treatment of children and adolescents is based mainly
problem he/she might have had, family history of				on experience with adults. The most typically used
mental disorders, as well as physical and psychological				mood stabilizers are lithium and valproate
traumas or situations that may cause stress.				(DepakoteÃ‚(R)), which are often very effective
Q: Whom should I consult to help my child?				for controlling mania and preventing recurrences of
A: First, consult your child's doctor. Ask for a complete				manic and depressive episodes in adults. Research on
health examination of your child. Describe the				the effectiveness of these and other medications in
behaviors that worry you. Ask whether your child				children and adolescents with bipolar disorder is
needs further evaluation by a specialist in child				ongoing. In addition, studies are investigating various
behavioral problems. Such specialists may include				forms of psychotherapy, including cognitive-behavioral
psychiatrists, psychologists, social workers, and				therapy, to complement medication treatment for this
behavioral therapists. Educators may also be needed				illness in young people.
to help your child.				Effective treatment depends on appropriate diagnosis
Q: How are mental disorders diagnosed in young				of bipolar disorder in children and adolescents. There is
children?				some evidence that using antidepressant medication to
A: Similar to adults, disorders are diagnosed by				treat depression in a person who has bipolar disorder
observing signs and symptoms. A skilled professional				may induce manic symptoms if it is taken without a
will consider these signs and symptoms in the context				mood stabilizer. In addition, using stimulant medications
of the child's developmental level, social and physical				to treat co-occurring ADHD or ADHD-like symptoms in
environment, and reports from parents and other				a child with bipolar disorder may worsen manic
caretakers or teachers, and an assessment will be				symptoms. While it can be hard to determine which
made according to criteria established by experts.				young patients will become manic, there is a greater
Very young children often cannot express their				likelihood among children and adolescents who have a
thoughts and feelings, which makes diagnosis a				family history of bipolar disorder. If manic symptoms
challenging task. The signs of a mental disorder in a				develop or markedly worsen during antidepressant or
young child may be quite different from those of an				stimulant use, a physician should be consulted
older child or an adult.				immediately, and diagnosis and treatment for bipolar
Q: Won't my child get better with time?				disorder should be considered.
A: Sometimes yes, but in other cases children need				Q: What difference does it make if a medication is
professional help. Problems that are severe, persistent,				specifically approved for use in children or not?
and impact on daily activities should be brought to the				A: Approval of a medication by the FDA means that
attention of the child's doctor. Great care should be				adequate data have been provided to the FDA by the
taken to help a child who is suffering, because mental,				drug manufacturer to show safety and efficacy for a
behavioral, or emotional disorders can affect the way				particular therapy in a particular population. Based on
the child grows up.				the data, a label indication for the drug is established
Q: Which mental disorders are seen in children?				that includes proper dosage, potential side effects, and
A: Mental disorders with possible onset in childhood				approved age. Doctors prescribe medications as they
include: anxiety disorders; attention deficit and disruptive				feel appropriate even if those uses are not included in
behavior disorders; autism and other pervasive				the labeling. Although in some cases there is extensive
developmental disorders; eating disorders (e.g., anorexia				clinical experience in using medications for children or
nervosa); mood disorders (e.g., major depression,				adolescents, in many cases there is not. Everyone
bipolar disorder); schizophrenia; and tic disorders. Under				agrees that more studies in children are needed if we
some circumstances, bed-wetting and soiling may be				are to know the appropriate dosages, how a drug
symptoms of a mental disorder.				works in children, and what effects there are on
Q: Are there situations in which it is advisable to use				learning and development.
psychotropic medications in young children?				Q: What does "off-label" use of a medication mean?
A: Psychotropic medications may be prescribed for				A: Many medications that are on the market have not
young children with mental, behavioral, or emotional				been officially approved by the FDA for use in children.
symptoms when the potential benefits of treatment				Treatment of children with these medications is called
outweigh the risks. Some problems are so severe and				"off-label" use. For some medications, the off-label use
persistent that they would have serious negative				is supported by data from well-conducted studies in
consequences for the child if untreated, and				children. For instance, some antidepressant medications
psychosocial interventions may not always be				have been shown to be effective in children and
effective by themselves. The safety and efficacy of				adolescents with depression. For other medications,
most psychotropic medications have not yet been				there are no controlled studies in children, but only
studied in young children. As a parent, you will want to				isolated clinical reports. In particular, the use of
ask many questions and evaluate with your doctor the				psychotropic medications in preschoolers has not been
risks of starting and continuing your child on these				adequately studied and must be considered very
medications. Learn everything you can about the				carefully by balancing severity of symptoms, degree
medications prescribed for your child, including potential				of impairment, and potential benefits and risks of
side effects. Learn which side effects are tolerable				treatment.
and which ones are threatening. In addition, learn and				Q: Why haven't many medications been tested in
keep in mind the goals of a particular treatment (e.g.,				children?
change in specific behaviors). Combining multiple				A: In the past, medications were not studied in children
psychotropic medications should be avoided in very				because of ethical concerns about involving children in
young children unless absolutely necessary.				clinical trials. However, this created a new problem: lack
Q: Does medication affect young children differently				of knowledge about the best treatments for children. In
from older children or adults?				clinical settings where children are suffering from
A: Yes. Young children's bodies handle medications				mental or behavioral disorders, medications are being
differently than older individuals and this has implications				prescribed at increasingly early ages. The FDA has
for dosage. The brains of young children are in a state				been urging that products be appropriately studied in
of very rapid development, and animal studies have				children and has offered incentives to drug
shown that the developing neurotransmitter systems				manufacturers to carry out such testing. The NIH and
can be very sensitive to medications. A great deal of				the FDA are examining the issue of medication
research is still needed to determine the effects and				research in children and are developing new research
benefits of medications in children of all ages. Yet it is				approaches.
important to remember that serious untreated mental				Q: Does the FDA approve medications for different
disorders themselves negatively impact brain				age groups among children?
development.				A: Yes. However, this is based on the data provided to
Q: If my preschool child receives a diagnosis of a				the FDA by the drug manufacturer and the policies in
mental disorder, does this mean that medications have				effect at the time of approval. For example,
to be used?				RitalinÃ‚(R) is approved for children age 6 and
A: No. Psychotropic medications are not generally the				older, whereas DexedrineÃ‚(R) is approved for
first option for a preschool child with a mental disorder.				children as young as 3. When RitalinÃ‚(R) was
The first goal is to understand the factors that may be				tested for efficacy by its manufacturer, only children
contributing to the condition. The child's own physical				age 6 and above were involved; therefore, age 6 was
and emotional state is key, but many other factors				approved as the lower age limit for RitalinÃ‚(R).
such as parental stress or a changing family				Q: Can events such as a death in the family, illness in a
environment may influence the child's symptoms.				parent, onset of poverty, or divorce cause symptoms?
Certain psychosocial treatments may be as effective				A: Yes. When a tragedy occurs or some extreme
as medication.				stress hits, every member of a family is affected,
Q: How should medication be included in an overall				even the youngest ones. This should also be
treatment plan?				considered when evaluating mental, emotional, or
A: When medication is used, it should not be the only				behavioral symptoms in a child.
strategy. There are other services that you may want

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Public concern over reports that very young children are being prescribed medication.

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