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...

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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