What are the contraindications for non-stimulant neurocognitive medications, such as Atomoxetine (Strattera), in a 9-year-old male?

From the Guidelines

Non-stimulant neurocognitive medications for a 9-year-old boy should be approached with caution due to potential concerns about their effectiveness and safety, and atomoxetine, a commonly used non-stimulant, has been associated with a greater risk of suicidal ideation in children and adolescents, as reported in a study published in 2022 1.

Reasons to Exercise Caution

When considering non-stimulant medications for ADHD in children, several factors must be taken into account:

• Potential side effects: Non-stimulant medications like atomoxetine, guanfacine, and clonidine can cause side effects such as fatigue, dizziness, decreased appetite, upset stomach, and mood changes, as noted in a study published in 2019 1.
• Effectiveness: Non-stimulant medications may not be as effective as stimulants for core ADHD symptoms in many children, according to a study published in 2022 1.
• Cardiovascular risks: Non-stimulant medications like guanfacine and clonidine can have cardiovascular effects, including changes in heart rate and blood pressure, as reported in a study published in 2019 1.
• Liver problems: Atomoxetine has been associated with liver problems, including hepatitis, in rare cases, as noted in a study published in 2022 1.

Key Considerations

Before starting non-stimulant medications, a comprehensive evaluation should be completed to:

• Confirm the ADHD diagnosis and rule out other conditions that might explain the symptoms.
• Assess the child's specific health profile, including any heart conditions, liver issues, or other medical concerns.
• Monitor the child's response to the medication and adjust the treatment plan as needed, as recommended in a study published in 2022 1.

Recommendations

Given the potential risks and benefits, non-stimulant medications like atomoxetine should be used with caution in children with ADHD, and regular monitoring by a healthcare provider is essential to assess both effectiveness and potential side effects, as reported in a study published in 2022 1. Some key points to consider when using non-stimulant medications in children with ADHD include:

• Starting with a low dose and gradually increasing as needed and tolerated.
• Monitoring for potential side effects, including suicidal ideation, and adjusting the treatment plan as needed.
• Considering alternative treatment options, such as behavioral therapy or lifestyle changes, in addition to or instead of medication.
• Regularly reviewing and updating the treatment plan to ensure the best possible outcomes for the child, as recommended in a study published in 2022 1.

From the FDA Drug Label

WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS Increased risk of suicidal ideation in children or adolescents (5.1) No suicides occurred in clinical trials (5.1) Patients started on therapy should be monitored closely (5. 1) WARNINGS AND PRECAUTIONS Suicidal Ideation - Monitor for suicidality, clinical worsening, and unusual changes in behavior. (5. 1) Severe Liver Injury - Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. (5. 2) Serious Cardiovascular Events- Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment. Effects on Blood Pressure and Heart Rate- Increase in blood pressure and heart rate; orthostasis and syncope may occur. Psychotic or Manic Symptoms- Consider discontinuing atomoxetine capsules if such new symptoms occur. (5. 5) Bipolar Disorder- Screen patients for bipolar disorder. (5.6) Aggressive behavior or hostility - Monitor for the appearance or worsening of aggressive behavior or hostility. (5.7) Possible allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash. (5.8) Effects on Urine Outflow- Urinary hesitancy and retention may occur. (5. 9) Priapism- Prompt medical attention is required in the event of suspected priapism. (5.10,17) Growth- Height and weight should be monitored in pediatric patients. (5.11)

Reasons not to take atomoxetine in a 9-year-old boy:

• Suicidal ideation: Increased risk of suicidal ideation in children and adolescents 2.
• Severe liver injury: Risk of severe liver injury, which may require discontinuation of the medication 2.
• Serious cardiovascular events: Risk of sudden death, stroke, and myocardial infarction, especially in patients with pre-existing cardiovascular disease 2.
• Psychotic or manic symptoms: Risk of emerging psychotic or manic symptoms, which may require discontinuation of the medication 2.
• Bipolar disorder: Risk of triggering bipolar disorder, which requires screening before starting the medication 2.
• Aggressive behavior or hostility: Risk of aggressive behavior or hostility, which requires monitoring 2.
• Allergic reactions: Risk of allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash 2.
• Effects on urine outflow: Risk of urinary hesitancy and retention 2.
• Priapism: Risk of priapism, which requires prompt medical attention 2.
• Growth effects: Requires monitoring of height and weight in pediatric patients 2.

From the Research

Reasons Not to Take Non-Stimulant Neurocognitive Medications

• Potential side effects: Atomoxetine, a non-stimulant neurocognitive medication, has been associated with common adverse events including headache, abdominal pain, decreased appetite, vomiting, somnolence, and nausea 3, 4, 5.
• Risk of suicidal ideation: A black-box warning for suicidal ideation has been published in the US prescribing information for atomoxetine, based on findings from a meta-analysis showing that atomoxetine is associated with a significantly higher incidence of suicidal ideation than placebo 3.
• Potential for liver injury: Rarely, atomoxetine may be associated with serious liver injury, with postmarketing data showing that three patients have had liver-related adverse events deemed probably related to atomoxetine treatment 3.
• Effects on heart rate and blood pressure: Atomoxetine has been associated with statistically significant increases in both heart rate and blood pressure in pediatric patients with ADHD, although these effects are generally well tolerated 3, 4.
• Potential for growth suppression: There was an initial loss in expected height and weight among atomoxetine recipients, although this eventually returned to normal in the longer term 3.

Considerations for 9-Year-Old Boys

• Atomoxetine is effective and generally well tolerated in children and adolescents with ADHD, including 9-year-old boys 3, 4, 5.
• However, the potential risks and side effects associated with atomoxetine should be carefully considered and weighed against the potential benefits of treatment.
• Alternative treatment options, such as behavioral therapy or other medications, may be considered for 9-year-old boys with ADHD, depending on individual needs and circumstances.

Important Factors to Consider

• The presence of co-morbid disorders, such as anxiety or tics, may affect the efficacy and safety of atomoxetine treatment 3, 5.
• The CYP2D6 genotype of the individual may affect the metabolism and efficacy of atomoxetine, and clinical dose selection should be based on both CYP2D6 genotype and peak concentration 5.
• The potential for abuse or misuse of non-stimulant neurocognitive medications, such as atomoxetine, is generally considered to be low 3, 6.