Strattera (Atomoxetine)

Several years ago after extensive controlled studies, the United States approved the use of the antidepressant "atomoxetine" (Strattera) in the treatment of ADHD in children, adolescents and adults. Atomoxetine is not a psychostimulant, but rather a so-called "selective norepinephrine reuptake inhibitor" (SNRI), meaning that it essentially affects the neurotransmitter norepinephrine (noradrenaline). In the medium term, however, the medication's interactions also affect the dopaminergic system. Following its approval in Germany in December 2004, Strattera (atomoxetine) became available on the German market as of March 2005. However, its approval is limited to use in the treatment of children and adolescents.
The effects of atomoxetine can first be seen a few days to a few weeks after intake. Adjustment to the medication may not be entirely easy.

Whereas German pharmaceutical companies tend to want to score points with the fact that atomoxetine is NOT a psychostimulant and is therefore a non-controlled prescription medication, the actual advantages of atomoxetine are that:

• Taking it once daily (or twice if need be) suffices.
• It has as good effect on those diagnosed with the predominantly inattentive type of ADHD.
• It is helpful for children with problems in the early morning since the effect lasts.
• Because atomoxetine is actually used to fight depression, it may have a good effect on other existing depressive moods and anxiety.

In previous years, a lot of money has gone into numerous studies on atomoxetine. During the course of these studies, various therapeutic indications of this medication (for ADHD and other accompanying disorders) were examined. It can therefore be assumed that atomoxetine is not merely a new preparation; at least five years of practical experience have gone into its study and use. This timeframe is, however, admittedly short compared to the over 50 years of experience with methylphenidate.

As such, a 97-week analysis of the use of atomoxetine in adults was recently published as part of a study on the long-term effects of Strattera. ( More information .) The medication demonstrated a high-level of therapeutic efficacy. According to the CAARS (Conners' Adult ADHD Rating Scales) survey, symptoms were reduced on average by 33% from an initial symptom score of 29.2 to an average score of 19.2. Nonetheless, it would be difficult to hope to use atomoxetine as THE alternative to psychostimulant therapy or to even forgo accompanying psychotherapeutic and psychosocial interventions for ADHD children. Some of the disadvantages of taking atomoxetine are:

• It is difficult to adjust the dosage of the medication, and the dosage of Strattera is administered on an individual basis.
• Although studies may suggest otherwise, many U.S. experts report that fewer children have a positive response to atomoxetine than to stimulants. Then again, it may be helpful to those children who suffer from the side effects of stimulants and to those, on whom such stimulants do not have a good effect.
• There are significant differences in the effect that it has on each individual, and it may interact with other medications due to their strong influence on the so-called cytochrome system. Such medications include almost all selective serotonin reuptake inhibitors (SSRIs) as well as other medications. Moreover, approximately 9 - 10% of all humans are "poor metabolizers," meaning that they metabolize medications more slowly. This slow metabolization then leads to the administration of higher doses and thereby increased side effects. In a warning, the Drug Commission of the German Medical Association reported of an attempt at suicide by taking 30 Strattera tablets (40 mg each = 1,200 mg) and buproprion (not available in Germany) at the same time. This attempt led to cardiac dysrhythmias (QT prolongation) and cramps. (For more information, see Strattera Poisoning.)
• Its side effects, including loss of appetite, agitation and trouble sleeping, are similar to those of stimulants. In the beginning, it is typical to experience a slight increase in pulse and blood pressure (noradrenergic effect on the nervous system). Additionally, it is becomes more common to experience more severe stomach pain following ingestion as well as dry mouth.
• Some experts report that somnolence constitutes a reason for discontinuing treatment with Strattera (atomoxetine). Patients and their parents state that without outside stimulation patients appear more tired than before even though the medication is in fact supposed to increase motivation. According to producers of the pharmaceutical, this side effect wears off after having taken it for a longer period of time. However, because treatment with atomoxetine targets the symptom "inattentiveness," this can lead to certain problems.
• There is a warning about rare cases of liver dysfunction (jaundice and elevated liver enzyme levels). Warnings have currently been issued as a result of 41 reported cases of liver damage and elevated level of bilirubin (frequency of occurrence 1: 50,000). In two cases, treatment with Strattera brought on hepatitis (inflammation of the liver), whereby liver enzyme levels climbed 40 times higher than normal and the level of bilirubin increased 12-fold. These levels may continue to increase even after discontinuing the medication. At present, no assumptions have been made as to a correlation between dosage and the side effect (known as an "idiosyncratic side effect," meaning that the exact cause is unknown). Warning about the side effects of Strattera in the "Deutsches Ärzteblatt" (Journal of the German Medical Association), in German

• At the end of September 2005, a warning was published both in the United States and in Germany concerning an increased risk of suicide as well as serious emotional fluctuations, irritability and aggressive behavior. Here, it must be noted that it is extremely difficult to distinguish previously existing mood fluctuations and other issues related to ADHD from what is known as a manic-depressive disorder in childhood or even the side effect of a particular medication. Studies report that approximately 0.4% of children being treated with Strattera have suicidal thoughts and that one child who attempted suicide fortunately did survive. It should actually be a given that children taking a new medication be monitored very carefully and regularly. In other words, very close contact between physician and patient should be ensured. Similar warnings are also currently being published with regards to the use of other antidepressants in the treatment of children and adolescents. In future, the United States will be also be providing relevant information with each box of Strattera dispensed. For more information on this topic, please see the website of the "Journal of the German Medical Association". Risk of Suicide When Taking Strattera, in German

• Some parents rely on Strattera because they have heard of possible effects that psychostimulants can have on growth. According to preliminary (unpublished) information, a slight decrease in height was documented in those being treated with Strattera. However, it can be assumed that these noticeable "abnormalities" are not side effects or damages resulting from taking the medication; rather, they stem from decelerated growth in children with ADHD. Children later rebound back from this "deceleration" and obtain normal body height.
• Until now, the primary disadvantage of Strattera has been cost. Each tablet costs approximately 3.96 euros. (There is one unit price for all of the various dosage forms.) The daily cost of treatment with Strattera most definitely goes above and beyond most physicians' budgets and will lead to serious issues in the way it is prescribed.

Some experts do point out, however, that atomoxetine may be used on drug addicts because there is less risk of abuse. Nonetheless, because atomoxetine treatment and the use of psychostimulants in treating ADHS patients with drug problems both require abstinence from drugs, utmost caution should be taken in evaluating such patients while being treated with atomoxetine. In such cases, Strattera abuse is possible. Thus far, unlike methylphenidate, there is a lack of studies that provide evidence for atomoxetine having a protective effect on the later development of an addiction. Unlike in the United States where Strattera was the first medication approved for the treatment of ADHD in adults, producers of the medication characterize its use as a first-line treatment in ADHD adults as "inappropriate." By contrast, treatment that has already been started during adolescence and has been found to be successful may be continued upon reaching adulthood. Although Strattera is approved for the treatment of adults in England, producers must now cancel this approval due to EU standardization.

Now that disappointed parents have begun reporting a discontinuation of atomoxetine treatment after 7 - 8 weeks in such places as self-help groups and internet forums, others must also be warned, in general, about getting false hopes with regards to using a single method of treatment ("unimodal therapy"). Atomoxetine treatment constitutes another treatment option as a part of multimodal ADHD therapies. However, it is certainly no wonder therapy. In the future, there may be differentiated treatment recommendations, in which children and adolescents benefit from atomoxetine treatment. These treatment recommendations may include combination atomoxetine and methylphenidate treatment.