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Medications Used in the Treatment of Tourette Syndrome plus ADHD

Stimulant Medications:

*There are delayed (extended release) acting formulations available for these drugs permitting once daily administration.

Medications Used in the Treatment of Anxiety With or Without OCD*

*Warning Information

Health care providers should carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either increases or decreases. Although FDA has not concluded that these drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy.

Heath care providers should carefully evaluate patients in whom depression persistently worsens, or emergent suicidality is severe, abrupt in onset, or was not part of the presenting symptoms, to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated.

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although FDA has not concluded that these symptoms are a precursor to either worsening of depression or the emergence of suicidal impulses, there is concern that patients who experience one or more of these symptoms may be at increased risk for worsening depression or suicidality. Therefore, therapy should be evaluated, and medications may need to be discontinued, when symptoms are severe, abrupt in onset, or were not part of the patients presenting symptoms. If a decision is made to discontinue treatment, certain of these medications should be tapered rather than stopped abruptly (see labeling for individual drug products for details).

Use of Drugs in the Pediatric Population

Some of the drug information that families may receive when the use of medication for tic disorder is discussed may indicate that a drug is not “approved” for children in the pediatric age group (usually under age 18 years). This information comes from what is called the “pediatric label” or “package insert”. This is information jointly agreed to by both the company and the Food and Drug Administration (FDA) to support the use of the drug as indicated. It is not unusual once a drug is on the market for it to be used in either a pediatric population or for an indication that is not in the label. An example of this is the drug clonidine, which is labeled for use in the treatment of high blood pressure in adults. However it has found widespread use for other disorders including tic disorders and ADHD. The Committee on Drugs in the American Academy of Pediatrics is very aware of this issue and has published a useful statement entitled “The Uses of Drugs Not Described in the Package Insert” in the July 2002 issue of Pediatrics (pp. 181-183). This statement points out that any labeling of a drug is not intended to preclude a physician from using his or her best judgment in the use of this medication. Because of rapidly advancing knowledge in pediatric therapeutics there can be widespread acceptance of the use of a drug not labeled for children before the label may be changed. There has been a very active effort in expanding the labeled drugs for the pediatric population in the last ten years so that children, their families and practitioners will have the benefit of the most up to date indications. When a certain drug is suggested for the treatment of a tic disorder or a co-morbid disorder. There is almost always significant published research to support such a recommendation. The child’s physician would be in the best position to discuss this with the family.

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Reviewed: 03/2006