Safety
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Strattera (atomoxetine hydrochloride) capsule
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
August 2012
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
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
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
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
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