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U.S. Department of Health and Human Services

Safety

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Strattera (atomoxetine hydrochloride) capsule

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

February 2014

Summary View

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Child and Adolescent Clinical Trials

  • The following adverse reactions occurred in at least 2% of child and adolescent CYP2D6 PM patients and were statistically significantly more frequent in PM patients compared with CYP2D6 EM patients: insomnia (11% of PMs, 6% of EMs); weight decreased (7% of PMs, 4% of EMs); constipation (7% of PMs, 4% of EMs); depression1 (7% of PMs, 4% of EMs); tremor (5% of PMs, 1% of EMs); excoriation (4% of PMs, 2% of EMs); middle insomnia (3% of PMs, 1% of EMs); Reference ID: 3457213 conjunctivitis (3% of PMs, 1% of EMs); syncope (3% of PMs, 1% of EMs); early morning awakening (2% of PMs, 1% of EMs); mydriasis (2% of PMs, 1% of EMs); sedation (4% of PMs, 2% of EMs).

Adult Clinical Trials

  • The following adverse events occurred in at least 2% of adult CYP2D6 poor metaboliser (PM) patients and were statistically significantly more frequent in PM patients compared to CYP2D6 extensive metaboliser (EM) patients: vision blurred (4% of PMs, 1% of EMs); dry mouth (35% of PMs, 17% of EMs); constipation (11% of PMs, 7% of EMs); feeling jittery (5% of PMs, 2% of EMs); decreased appetite (23% of PMs, 15% of EMs); tremor (5% of PMs, 1% of EMs); insomnia (19% of PMs, 11% of EMs); sleep disorder (7% of PMs, 3% of EMs); middle insomnia (5% of PMs, 3% of EMs); terminal insomnia (3% of PMs, 1% of EMs); urinary retention (6% of PMs, 1% of EMs); erectile dysfunction (21% of PMs, 9% of EMs); ejaculation disorder (6% of PMs, 2% of EMs); hyperhidrosis (15% of PMs, 7% of EMs); peripheral coldness (3% of PMs, 1% of EMs).

 

August 2013

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CONTRAINDICATIONS

  • Severe Cardiovascular Disorders - Strattera should not be used in patients with severe cardiac or vascular disorders whose condition would be expected to deteriorate if they experience increases in blood pressure or heart rate that could be clinically important (for example, 15 to 20 mm Hg in blood pressure or 20 beats per minute in heart rate).
 

WARNINGS AND PRECAUTIONS

  • Effects on Blood Pressure and Heart Rate - Strattera should be used with caution in patients whose underlying medical conditions could be worsened by increases in blood pressure or heart rate such as certain patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease…
  • Aggressive Behavior or Hostility - Patients beginning treatment for ADHD should be monitored for the appearance or worsening of aggressive behavior or hostility…

 

August 2012

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WARNINGS AND PRECAUTIONS 

Severe Liver Injury
  • Postmarketing reports indicate that Strattera can cause severe liver injury. Although no evidence of liver injury was detected in clinical trials of about 6000 patients, there have been rare cases of clinically significant liver injury that were considered probably or possibly related to Strattera use in postmarketing experience…

 

July 2012

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WARNINGS AND PRECAUTIONS

Effects on Blood Pressure and Heart Rate
  • In adult clinical trials where EM/PM status was available, the mean heart rate increase in PM patients was significantly higher than in EM patients (11 beats/minute versus 7.5 beats/minute). The heart rate effects could be clinically important in some PM patients. In placebo-controlled registration studies involving adult patients, tachycardia was identified as an adverse event for 1.5% (8/540) of Strattera patients compared with 0.5% (2/402) of placebo patients. In adult clinical trials where EM/PM status was available, the mean change from baseline in diastolic blood pressure in PM patients was higher than in EM patients (4.21 versus 2.13 mm Hg) as was the mean change from baseline in systolic blood pressure (PM: 2.75 versus EM: 2.40 mm Hg). The blood pressure effects could be clinically important in some PM patients.

 

June 2012

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CONTRAINDICATIONS

Severe Cardiovascular Disorders
  • Strattera should not be used in patients with severe cardiovascular disorders whose condition would be expected to deteriorate if they experience increases in blood pressure or heart rate that could be clinically important (for example, 15 to 20 mm Hg in blood pressure or 20 beats per minute in heart rate).
 

WARNINGS and PRECAUTIONS

Effects on Blood Pressure and Heart Rate
  • update reflects findings from a Cardiovascular Safety Report (eCTD sequence 0051) “Analysis of the Changes in Hemodynamic Parameters of Blood Pressure and Heart Rate Associated with Atomoxetine Treatment in Pediatric and Adult Patients with ADHD in Clinical Trials and in Healthy Adult Subjects who are CYP-2D6 Poor Metabolizers”
  • New Table Added
 

ADVERSE REACTIONS

Clinical Trials Experience
  • Additional data from ADHD clinical trials (controlled and uncontrolled) has shown that approximately 5 to 10% of pediatric patients experienced potentially clinically important changes in heart rate (≥20 beats per min) or blood pressure (≥15 to 20 mm Hg).
  • Additional data from ADHD clinical trials (controlled and uncontrolled) has shown that approximately 5 to 10% of adult patients experienced potentially clinically important changes in heart rate (≥20 beats per min) or blood pressure (≥15 to 20 mm Hg)...
Postmarketing Spontaneous Reports
  • Peripheral vascular effects — Raynaud’s phenomenon

 

July 2010

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WARNINGS and PRECAUTIONS

Allergic Events
  • Although uncommon, allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash, have been reported in patients taking Strattera.

 

ADVERSE REACTIONS

Table 3: Common Treatment-Emergent Adverse Reactions Associated with the Use of Strattera in Acute (up to 25 weeks) Adult Trials
  • Nervous System Disorders: Paraesthesia
Postmarketing Spontaneous Reports
  • Nervous system disorders- paraesthesia in children and adolescents