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

A  Note  to  Parents
A: When medication is used, it should not be
There has been public concern over reportsthe only strategy. There are other services
that very young children are being prescribedthat you may want to investigate for your
psychotropic medications. The studies to datechild. Family support services, educational
are incomplete, and much more needs to beclasses, behavior management techniques, as
learned about young children who are treatedwell as family therapy and other approaches
with medications for all kinds of illnesses.should be considered. If medication is
In the field of mental health, new studiesprescribed, it should be monitored and
are needed to tell us what the bestevaluated  regularly.
treatments are for children with emotional
and  behavioral  disturbances.Q: What medications are used for which kinds
of  childhood  mental  disorders?
Children are in a state of rapid change and
growth during their developmental years.A: There are several major categories of
Diagnosis and treatment of mental disorderspsychotropic medications: stimulants,
must be viewed with these changes in mind.antidepressants, antianxiety agents,
While some problems are short-lived and don'tantipsychotics, and mood stabilizers. For
need treatment, others are persistent andmedications approved by the FDA for use in
very serious, and parents should seekchildren, dosages depend on body weight and
professional  help  for  their  children.age. The Medications Chart in this booklet
shows the most commonly prescribed
Not long ago, it was thought that many brainmedications for children with mood or anxiety
disorders such as anxiety disorders,disorders  (including  OCD).
depression, and bipolar disorder began only
after  childhood.Stimulant Medications: There are four
stimulant medications that are approved for
We now know they can begin in earlyuse in the treatment of attention deficit
childhood. An estimated 1 in 10 children andhyperactivity disorder (ADHD), the most
adolescents in the United States suffers fromcommon behavioral disorder of childhood.
mental illness severe enough to cause someThese medications have all been extensively
level of impairment. Fewer than one in fivestudied and are specifically labeled for
of these ill children receives treatment.pediatric use. Children with ADHD exhibit
Perhaps the most studied, diagnosed, andsuch symptoms as short attention span,
treated childhood-onset mental disorder isexcessive activity, and impulsivity that
attention deficit hyperactivity disordercause substantial impairment in functioning.
(ADHD), but even with this disorder there isStimulant medication should be prescribed
a need for further research in very youngonly after a careful evaluation to establish
children.the diagnosis of ADHD and to rule out other
disorders or conditions. Medication treatment
This booklet contains answers to frequentlyshould be administered and monitored in the
asked questions regarding the treatment ofcontext of the overall needs of the child and
children  with  mental  disorders.family, and consideration should be given to
combining it with behavioral therapy. If the
Questions  and  Answerschild is of school age, collaboration with
teachers  is  essential.
Q: What should I do if I am concerned about
mental, behavioral, or emotional symptoms inAntidepressant and Antianxiety Medications:
my  young  child?These medications follow the stimulant
medications in prevalence among children and
A: Talk to your child's doctor. Ask questionsadolescents. They are used for depression, a
and find out everything you can about thedisorder recognized only in the last 20 years
behavior or symptoms that worry you. Everyas a problem for children, and for anxiety
child is different and even normaldisorders, including obsessive-compulsive
development varies from child to child.disorder (OCD). The medications most widely
Sensory processing, language, and motorprescribed for these disorders are the
skills are developing during early childhood,selective serotonin reuptake inhibitors (the
as well as the ability to relate to parentsSSRIs).
and to socialize with caregivers and other
children. If your child is in daycare orIn the human brain, there are many
preschool, ask the caretaker or teacher if"neurotransmitters" that affect the way we
your child has been showing any worrisomethink, feel, and act. Three of these
changes in behavior, and discuss this withneurotransmitters that antidepressants
your  child's  doctor.influence are serotonin, dopamine, and
norepinephrine. SSRIs affect mainly serotonin
Q: How do I know if my child's problems areand have been found to be effective in
serious?treating depression and anxiety without as
many side effects as some older
A: Many everyday stresses cause changes inantidepressants.
behavior. The birth of a sibling may cause a
child to temporarily act much younger. It isAntipsychotic Medications: These medications
important to recognize such behavior changes,are used to treat children with
but also to differentiate them from signs ofschizophrenia, bipolar disorder, autism,
more serious problems. Problems deserveTourette's syndrome, and severe conduct
attention when they are severe, persistent,disorders. Some of the older antipsychotic
and impact on daily activities. Seek help formedications have specific indications and
your child if you observe problems such asdose guidelines for children. Some of the
changes in appetite or sleep, socialnewer "atypical" antipsychotics, which have
withdrawal, or fearfulness; behavior thatfewer side effects, are also being used for
seems to slip back to an earlier phase suchchildren. Such use requires close monitoring
as bed-wetting; signs of distress such asfor  side  effects.
sadness or tearfulness; self-destructive
behavior such as head banging; or a tendencyMood Stabilizing Medications: These
to have frequent injuries. In addition, it ismedications are used to treat bipolar
essential to review the development of yourdisorder (manic-depressive illness). However,
child, any important medical problem he/shebecause there is very limited data on the
might have had, family history of mentalsafety and efficacy of most mood stabilizers
disorders, as well as physical andin youth, treatment of children and
psychological traumas or situations that mayadolescents is based mainly on experience
cause  stress.with adults. The most typically used mood
stabilizers are lithium and valproate
Q:  Whom  should  I consult to help my child?(DepakoteÂ(R)), which are often very
effective for controlling mania and
A: First, consult your child's doctor. Askpreventing recurrences of manic and
for a complete health examination of yourdepressive episodes in adults. Research on
child. Describe the behaviors that worry you.the effectiveness of these and other
Ask whether your child needs furthermedications in children and adolescents with
evaluation by a specialist in childbipolar disorder is ongoing. In addition,
behavioral problems. Such specialists maystudies are investigating various forms of
include psychiatrists, psychologists, socialpsychotherapy, including cognitive-behavioral
workers, and behavioral therapists. Educatorstherapy, to complement medication treatment
may  also  be  needed  to  help  your  child.for  this  illness  in  young  people.
Q: How are mental disorders diagnosed inEffective treatment depends on appropriate
young  children?diagnosis of bipolar disorder in children and
adolescents. There is some evidence that
A: Similar to adults, disorders are diagnosedusing antidepressant medication to treat
by observing signs and symptoms. A skilleddepression in a person who has bipolar
professional will consider these signs anddisorder may induce manic symptoms if it is
symptoms in the context of the child'staken without a mood stabilizer. In addition,
developmental level, social and physicalusing stimulant medications to treat
environment, and reports from parents andco-occurring ADHD or ADHD-like symptoms in a
other caretakers or teachers, and anchild with bipolar disorder may worsen manic
assessment will be made according to criteriasymptoms. While it can be hard to determine
established by experts. Very young childrenwhich young patients will become manic, there
often cannot express their thoughts andis a greater likelihood among children and
feelings, which makes diagnosis a challengingadolescents who have a family history of
task. The signs of a mental disorder in abipolar disorder. If manic symptoms develop
young child may be quite different from thoseor markedly worsen during antidepressant or
of  an  older  child  or  an  adult.stimulant use, a physician should be
consulted immediately, and diagnosis and
Q:  Won't  my  child  get  better  with time?treatment for bipolar disorder should be
considered.
A: Sometimes yes, but in other cases children
need professional help. Problems that areQ: What difference does it make if a
severe, persistent, and impact on dailymedication is specifically approved for use
activities should be brought to the attentionin  children  or  not?
of the child's doctor. Great care should be
taken to help a child who is suffering,A: Approval of a medication by the FDA means
because mental, behavioral, or emotionalthat adequate data have been provided to the
disorders can affect the way the child growsFDA by the drug manufacturer to show safety
up.and efficacy for a particular therapy in a
particular population. Based on the data, a
Q: Which mental disorders are seen inlabel indication for the drug is established
children?that includes proper dosage, potential side
effects, and approved age. Doctors prescribe
A: Mental disorders with possible onset inmedications as they feel appropriate even if
childhood include: anxiety disorders;those uses are not included in the labeling.
attention deficit and disruptive behaviorAlthough in some cases there is extensive
disorders; autism and other pervasiveclinical experience in using medications for
developmental disorders; eating disorderschildren or adolescents, in many cases there
(e.g., anorexia nervosa); mood disordersis not. Everyone agrees that more studies in
(e.g., major depression, bipolar disorder);children are needed if we are to know the
schizophrenia; and tic disorders. Under someappropriate dosages, how a drug works in
circumstances, bed-wetting and soiling may bechildren, and what effects there are on
symptoms  of  a  mental  disorder.learning  and  development.
Q: Are there situations in which it isQ: What does "off-label" use of a medication
advisable to use psychotropic medications inmean?
young  children?
A: Many medications that are on the market
A: Psychotropic medications may be prescribedhave not been officially approved by the FDA
for young children with mental, behavioral,for use in children. Treatment of children
or emotional symptoms when the potentialwith these medications is called "off-label"
benefits of treatment outweigh the risks.use. For some medications, the off-label use
Some problems are so severe and persistentis supported by data from well-conducted
that they would have serious negativestudies in children. For instance, some
consequences for the child if untreated, andantidepressant medications have been shown to
psychosocial interventions may not always bebe effective in children and adolescents with
effective by themselves. The safety anddepression. For other medications, there are
efficacy of most psychotropic medicationsno controlled studies in children, but only
have not yet been studied in young children.isolated clinical reports. In particular, the
As a parent, you will want to ask manyuse of psychotropic medications in
questions and evaluate with your doctor thepreschoolers has not been adequately studied
risks of starting and continuing your childand must be considered very carefully by
on these medications. Learn everything youbalancing severity of symptoms, degree of
can about the medications prescribed for yourimpairment, and potential benefits and risks
child, including potential side effects.of  treatment.
Learn which side effects are tolerable and
which ones are threatening. In addition,Q: Why haven't many medications been tested
learn and keep in mind the goals of ain  children?
particular treatment (e.g., change in
specific behaviors). Combining multipleA: In the past, medications were not studied
psychotropic medications should be avoided inin children because of ethical concerns about
very young children unless absolutelyinvolving children in clinical trials.
necessary.However, this created a new problem: lack of
knowledge about the best treatments for
Q: Does medication affect young childrenchildren. In clinical settings where children
differently  from  older  children or adults?are suffering from mental or behavioral
disorders, medications are being prescribed
A: Yes. Young children's bodies handleat increasingly early ages. The FDA has been
medications differently than olderurging that products be appropriately studied
individuals and this has implications forin children and has offered incentives to
dosage. The brains of young children are in adrug manufacturers to carry out such testing.
state of very rapid development, and animalThe NIH and the FDA are examining the issue
studies have shown that the developingof medication research in children and are
neurotransmitter systems can be verydeveloping  new  research  approaches.
sensitive to medications. A great deal of
research is still needed to determine theQ: Does the FDA approve medications for
effects and benefits of medications indifferent  age  groups  among  children?
children of all ages. Yet it is important to
remember that serious untreated mentalA: Yes. However, this is based on the data
disorders themselves negatively impact brainprovided to the FDA by the drug manufacturer
development.and the policies in effect at the time of
approval. For example, RitalinÂ(R) is
Q: If my preschool child receives a diagnosisapproved for children age 6 and older,
of a mental disorder, does this mean thatwhereas DexedrineÂ(R) is approved for
medications  have  to  be  used?children as young as 3. When RitalinÂ(R)
was tested for efficacy by its manufacturer,
A: No. Psychotropic medications are notonly children age 6 and above were involved;
generally the first option for a preschooltherefore, age 6 was approved as the lower
child with a mental disorder. The first goalage  limit  for  RitalinÂ(R).
is to understand the factors that may be
contributing to the condition. The child'sQ: Can events such as a death in the family,
own physical and emotional state is key, butillness in a parent, onset of poverty, or
many other factors such as parental stress ordivorce  cause  symptoms?
a changing family environment may influence
the child's symptoms. Certain psychosocialA: Yes. When a tragedy occurs or some extreme
treatments may be as effective as medication.stress hits, every member of a family is
affected, even the youngest ones. This should
Q: How should medication be included in analso be considered when evaluating mental,
overall  treatment  plan?emotional, or behavioral symptoms in a child.



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