Atomoxetine chemical structure
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Tomoxetine

Atomoxetine hydrochloride is a prescription drug used in the treatment of attention-deficit hyperactivity disorder (ADHD). It is manufactured and marketed under the brand name Strattera® by Eli Lilly and Company. more...

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Atomoxetine is classified as a selective norepinephrine reuptake inhibitor, and is approved for use in children, adolescents, and adults. However, its efficacy has not been studied in children under 6 years old. Its advantage over stimulants for the treatment of ADHD is that it is not considered to have significant abuse potential, is not scheduled as a controlled substance and has proven in clinical trials to offer 24 hour coverage of symptoms associated with ADHD in adults and children.

Side-effects

Strattera carries a "black box warning", the strongest warning required by US regulators. In September 2005, Strattera was determined to increase risk of suicidal thoughts among children and adolescents; one attempted suicide and five cases of suicidal thoughts were reported out of 1,357 young patients taking Strattera, while none were reported out of a control group of 851 taking placebos. ,

Two confirmed cases of liver injury have been reported by Eli Lilly and Company out of approximately two million prescriptions written. In both cases upon discontinuation of atomoxetine, patients' liver functions returned to normal.

A significant minority of adult male patients taking Strattera suffer minor to severe sexual side effects, including erectile dysfunction, painful orgasm, and the decoupling of orgasm from ejaculation, wherein ejaculation takes place up to ten seconds after the orgasmic experience has occurred.

Safety & abuse liability

There are also very few studies assessing its abuse liability. Typically, three types of studies are conducted to measure abuse liability. One directly tests whether people or non-humans will self-administer the drug. The second tests whether the subjective effects of the drug are similar to known drugs of abuse. The third indirectly assesses whether a drug “feels good” by giving the drug in a specific location and testing whether animals will spend more time in that area (conditioned place preference).

To date, two studies have reported that monkeys will not self-administer atomoxetine at the doses tested (Gasior et al, Neuropharm 30:758, 2005; Wee & Woolverton, Drug Alcohol Depend 75:271, 2004). However, rats, pigeons and monkeys trained to distinguish cocaine or methamphetamine from saline indicate that atomoxetine produces effects indistinguishable from low doses of cocaine or methamphetamine, but not at all like high doses of cocaine (Spealman, JPET 271:53, 1995; Sasaki et al., Psychopharm 120:303, 1995). No place preference studies have been conducted with atomoxetine.

These findings suggest that atomoxetine has a low to moderate risk for domestic abuse, but that it is not completely safe and harmless.

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Antidepressants Are Effective in Treatment of Adult ADHD
From American Family Physician, 3/15/99 by Grace Brooke Huffman

Diagnosis of attention-deficit/hyperactivity disorder (ADHD) in adults is difficult. Some evidence indicates that most children outgrow this disorder by adulthood, but other evidence shows that some adults may continue to have at least residual symptoms of ADHD. Higgins reviewed the literature to assess the efficacy of antidepressants compared with stimulants in adults who presented with attention deficits. A Medline search yielded 20 studies that reported on antidepressant or stimulant treatment in adults with attention deficits. These studies were reviewed to determine the type of medication used and the percentage of patients who were responders. Of the nine studies of stimulants, only five were placebo-controlled double-blind studies. Three of these reported significant improvement in patients taking the stimulant compared with placebo; the other two studies showed no difference between the two. Only three of the 11 studies of antidepressants were placebo-controlled. One study evaluated the use of a monoamine oxidase inhibitor and showed no difference between the active treatment and placebo. The other two studies (using desipramine and tomoxetine, a medication that is not available in the United States) found that 68 percent and 52 percent of patients responded, respectively, compared with none and 2 percent of those in the placebo group. NonEplacebo-controlled studies of bupropion and venlafaxine found good response in adults with attention deficits. Further studies, including those comparing antidepressants, stimulants and placebo, are needed to determine the best treatment in adults with ADHD. However, the author notes that using an antidepressant in adequate dosages may be a satisfactory alternative to prescribing a controlled substance (i.e., a stimulant) in these patients.

Higgins ES. A comparative analysis of antidepressants and stimulants for the treatment of adults with attention-deficit hyperactivity disorder. J Fam Pract January 1999; 48:15-20.

COPYRIGHT 1999 American Academy of Family Physicians
COPYRIGHT 2000 Gale Group

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