Home > News & Conferences > News > Drugography: A Snapshot of Atomoxetine (Strattera®)
Atomoxetine (Strattera) was the first non-stimulant approved by the FDA for treating attention-deficit/hyperactivity disorder (ADHD)1 and is widely prescribed to adults and children. But how can you tell if your patient is following your regimen as prescribed?
Manufactured by Eli Lilly, Strattera is indicated for the treatment of ADHD in adults and children at least 6 years old, recommended as part of a “total treatment program for ADHD”2 in tandem with other behavioral approaches such as counseling. (Visit the Strattera website)
Taken orally in pill form, atomoxetine is categorized as a selective norepinephrine reuptake inhibitor, which works by increasing the levels of norepinephrine, a natural substance in the brain that helps manage behavior. Some of the many serious side effects include chest pain, difficulty swallowing or breathing, dizziness, swelling, hives or seizures.3 Atomoxetine may slow down children’s growth or weight gain, and there is the possibility of sudden death in children and teenagers with heart defects or serious heart problems.3 (Learn more about side effects, other at-risk groups and precautions from PubMed)
Please note that atomoxetine is associated with an increased risk of suicidal thoughts or actions in children and young adults, especially at the start of treatment or after a change in dose. This is clearly stated on the Strattera website and in the medication guide.
Strattera was FDA-approved for treating ADHD in 2002, but it wasn’t until 2008, after an 18-month clinical trial was conducted on about 600 children and adolescents aged 6 to 15, that it was approved for this age group.1 A key benefit of prescribing a non-stimulant is the reduced likelihood of addiction,4 which might be of special concern when treating youth and those with a history of substance abuse. But unlike stimulants, which begin working right away, Strattera’s effectiveness is thought to depend on the regulation of norepinephrine and other neurotransmitters in the brain, which can take several weeks to reach optimal levels. In addition, those taking Strattera still may exhibit some ADHD symptoms. (Read the WebMD article)
Of even greater concern is the increased risk of suicidal thoughts or actions in children and teenagers. According to Strattera’s website, in clinical studies involving more than 2,200 child or teenage ADHD patients, four out of every 1,000 developed suicidal thoughts. No suicides were reported.
In November 2011, the FDA released a safety communication declaring that a large study in children and young adults treated for ADHD revealed no association between use of certain ADHD medications, including atomoxetine, and adverse cardiovascular events.5 The study was published that same month in the “New England Journal of Medicine.”6 (Review the November 2011 FDA safety communication) (Read the study)
The FDA followed up in December to assert there was no increased risk of serious adverse cardiovascular events in adults treated with ADHD medications.7 (Read the December 2011 FDA safety communication)
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