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Limited Use
[what does this mean?]
Generic drug name:
atomoxetine
(at oh MOX i teen)
Brand name(s):
STRATTERA
GENERIC:
available
FAMILY:
Central Nervous System Stimulators
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
Atomoxetine caused adverse effects in animal studies at very low drug exposures: these included a decrease in numbers of live fetuses, decreased pup survival, as well as incomplete bone formation of the spine and missing or malformed arteries. Atomoxetine produced a change in DNA structure which can be a precursor to some tumors. Women taking atomoxetine should talk to their doctor if they are pregnant or plan to become pregnant.
Breast-feeding Warning
Atomoxetine was excreted in animal milk. It is not known whether atomoxetine is excreted in human breast milk, but many drugs are excreted in milk. To avoid potential risks, women breastfeeding an infant should talk their doctor about discontinuing the drug or discontinuing nursing.
Safety Warnings For This Drug [top]
FDA BLACK BOX WARNING
Suicidal Ideation in Children and Adolescents — STRATTERA (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of STRATTERA in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder. Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of STRATTERA in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving STRATTERA compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials.[1]
Drug treatment is not suitable for all children with attention deficit hyperactivity disorder (ADHD). Drug treatment is not intended for use in patients who exhibit symptoms of the disorder that result primarily from environmental factors (school, home), learning disabilities and/or other psychiatric disorders, including psychosis.
Facts About This Drug [top]
Atomoxetine (STRATTERA) is approved by the Food and Drug Administration (FDA) to treat attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Atomoxetine increases function of the neurotransmitter norepinephrine. The drug is intended to be part of a therapy that includes educational, psychological and social measures.[2] It may control, but does not cure, ADHD.
The prescription information for atomoxetine includes an FDA black-box warning concerning suicidal...
Atomoxetine (STRATTERA) is approved by the Food and Drug Administration (FDA) to treat attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Atomoxetine increases function of the neurotransmitter norepinephrine. The drug is intended to be part of a therapy that includes educational, psychological and social measures.[2] It may control, but does not cure, ADHD.
The prescription information for atomoxetine includes an FDA black-box warning concerning suicidal thinking in children and adolescents and additional warning statements that alert health care providers to the increased risk of liver damage, heart-related problems and psychiatric symptoms when taking this drug.[3] These four concerns are highlighted in the FDA-approved Medication Guide for atomoxetine (and in the "Side effects" section below), which advises patients of the risks associated with the drug and precautions that can be taken to help patients use this drug more safely.[4]
Atomoxetine is one of a limited number of drugs for which the FDA requires an FDA-approved Medication Guide to be dispensed when the prescription is filled or refilled. (Click here to view the Medication Guide for this drug.) An FDA advisory committee has unanimously recommended that all prescription drugs be accompanied by such Medication Guides, but currently, less than 5 percent of drugs are. The other 95 percent of drugs are accompanied by unregulated, often dangerously incomplete, information leaflets not approved by the FDA.
The editors of The Medical Letter on Drugs and Therapeutics, an independent source of drug information written for pharmacists and physicians, reviewed atomoxetine on Aug. 16, 2004, and concluded:
There is no convincing evidence that atomoxetine (STRATTERA) is as effective or as well tolerated as stimulants such as methylphenidate (CONCERTA, and others) for treatment of ADHD. As The Medical Letter recommended when the drug was first marketed, until more data become available, atomoxetine is best reserved for patients who have not responded to or cannot tolerate stimulants, and for those who do not want to take, or have their children take, a controlled substance.[5]
Side effects
Common side effects with atomoxetine include indigestion, fatigue, dizziness, decreased appetite and mood swings. Side effects that have caused adults to discontinue atomoxetine include chest pain, insomnia and urinary retention, while children and adolescents were more apt to stop due to aggression, drowsiness, irritability and vomiting.
In 2010, an FDA advisory stated that allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria and rash have been reported in patients taking atomoxetine. The advisory also noted that these allergic reactions may be uncommon.[6]
Liver damage
In some patients, atomoxetine can cause severe liver injury that may progress to liver failure, potentially resulting in death or the need for a liver transplant. Atomoxetine should be stopped and the prescribing physician notified immediately if you or a family member develops any of the following symptoms of potential liver toxicity:
An article published in the FDA newsletter in 2009 discussed six additional cases of serious liver injury that were reported to the FDA between January 2005 and March 2008. These case reports were received after the 2004 atomoxetine drug label update on serious liver injury associated with atomoxetine use.[7]
Heart-related problems
There have been reports to the FDA of several heart-related problems in individuals taking doses of ADHD medications as prescribed: sudden death in patients who have an underlying serious heart problem or defect, stroke and heart attack in adults, and increased blood pressure and heart rate. When considering atomoxetine treatment, doctors should carefully check patients for heart problems and check patients’ blood pressure and heart rate regularly during treatment. Patients and their caregivers should call their doctor immediately if someone taking atomoxetine has any signs of heart problems, such as chest pain, shortness of breath or fainting.[4]
In 2011, Health Canada, an agency similar to the FDA, issued an advisory concerning the use of atomoxetine and the risk of increased blood pressure and increased heart rate.[8] In May 2012, the U.K.’s Medicines and Healthcare products Regulatory Agency also issued an advisory concerning these same risks.[9]
Psychiatric symptoms
New psychotic symptoms (such as hearing voices, believing things that are not true and being suspicious) and new manic symptoms have been reported in patients using atomoxetine. Parents should contact the doctor right away if new mental symptoms develop.[4]
Increased risk of suicidal thinking has been reported in children and adolescents being treated with this medication. Pediatric patients being treated with atomoxetine should be closely observed for clinical worsening as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial months of a drug-therapy course or at times of dose increases or decreases.[10]
In 2013, the Therapeutic Goods Administration, a branch of the Australian government’s Department of Health, stated that as of July 2013, it had received 74 reports of psychiatric disorders associated with atomoxetine use and that suicidal ideation was reported in more than half of these cases.[11]
In 2015, Health Canada updated the warning section of the labels of drugs used to treat ADHD on the risk of suicidal thoughts and behaviors. The advisory stated that Health Canada had received reports that included thoughts of suicide, suicide attempts and, in a very small number of cases, suicide. [12]
Other concerns with atomoxetine
Atomoxetine should not be used by people with narrow-angle glaucoma.[2]
Concern exists about the effects of long-term atomoxetine medication on the growth of children. Short-term studies show that children gain less height and weight when using atomoxetine.[2],[13] If height and weight gain in children are below normal, consideration should be given to interrupting therapy.
The drug has not been studied in children younger than 6 or in the elderly. The effectiveness of taking atomoxetine beyond nine weeks in children or 10 weeks in adults has not been evaluated. The safety of taking atomoxetine beyond one year has not been studied in controlled trials. Long-term effects of the drug are not known.[2]
Regulatory actions surrounding atomoxetine
2012: The FDA updated the information on the drug product label of atomoxetine, noting post-marketing reports of severe liver injury associated with atomoxetine use.[14]
In 2012, the FDA also updated the information on the drug product label of atomoxetine, indicating that the drug should not be used in patients with severe cardiovascular disorders. This includes patients whose condition would likely deteriorate with increases in blood pressure or heart rate.[15]
2013: The FDA issued another advisory that atomoxetine should not be used in patients with severe cardiovascular disorders whose condition would likely deteriorate with increases in blood pressure or heart rate.
Before You Use This Drug [top]
Do not use if you have or have had:
Tell your doctor if you have or have had:
Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
Atomoxetine is a relatively new drug, and information about drug interactions is scant. People in clinical trials are usually on few other drugs and have few other conditions. Listed are potentially serious interactions in FDA-approved labeling and other medical references that are known or suspected to date. New scientific techniques allow researchers to predict some drug interactions before they have been documented in people. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. The number of new drugs approved for marketing increases the chance of drug interactions, and new drug interactions are being identified with old drugs. Be vigilant. Make sure to tell your doctor and pharmacist the drugs you are taking and tell your doctor if you are taking any of these interacting drugs:
Drugs that inhibit monoamine oxidase (MAO inhibitors) may cause serious, at times fatal reactions, such as extreme agitation, rapid fluctuations of mental status, rigid muscles, twitching, or coma. Do not take atomoxetine within two weeks of: deprenyl, ELDEPRYL, furazolidone, FUROXONE, isocarboxazid, MARPLAN, MATULANE, NARDIL, PARNATE, phenelzine, procarbazine, selegiline, tranylcypromine.
Using atomoxetine with asthma drugs called beta agonists may add to adverse effects of the heart and circulation: albuterol, PROVENTIL, VENTOLIN, VOLMAX.
If you use atomoxetine with these drugs, your doctor may adjust your doses: CARDIOQUIN, fluoxetine, PAXIL, paroxetine, PROZAC, QUINAGLUTE, QUINIDEX, quinidine, quinidine gluconate, quinidine polygalacturonate, quinidine sulfate.
Using atomoxetine with anticholinergic drugs (see p. 617) could add to the adverse effect of urinary retention: amitriptyline, AMOXAPINE, antidepressants (tricyclic), antihistamines, ARTANE, ASENDIN, atropine, AVENTYL, belladonna, benztropine, clidinium, COGENTIN, cyclobenzaprine, desipramine, DETROL, dicyclomine, DITROPAN, doxepin, ELAVIL, FLEXERIL, glycopyrrolate, hyoscyamine, imipramine, LIBRAX, NORPRAMIN, nortriptyline, oxybutin, PROBANTHINE, propantheline, protriptyline, scopolamine, SINEQUAN, SURMONTIL, TOFRANIL, tolterodine, TRANS-DERM SCOP, trihexyphenidyl, trimpramine, VISTARIL, VIVACTIL.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
Periodic Tests[top]
Ask your doctor which of these tests should be done periodically while you are taking this drug:
By your doctor:
By your parent(s):
By your teacher(s):
last reviewed May 31, 2024
Worst Pills, Best Pills is a project of Public Citizen's Health Research Group Group. As an independent, nonprofit organization, we take no corporate or government contributions and accept no advertising. Copyright © 2024 Public Citizen's Health Research Group. All rights reserved.
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