Strattera Active Substance Atomoxetine
Indication - treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
Warnings from US Food and Drug Administration - Public Health Advisory:
Suicidal Thinking in Children and Adolescents Being Treated With Strattera (Atomoxetine)
This 2005 Public Health Advisory has been archived on the FDA web site.
The FDA warning was about liver injury and other postmarketing reports of ADRs.
Adverse Reactions
Postmarketing Spontaneous Reports
Unless otherwise specified, these adverse reactions have occurred in adults and children and adolescents.
General disorders and administration site conditions - Lethargy.
Nervous system disorders - Hypoaesthesia, paraesthesia in children and adolescents; sensory disturbances.
Urogenital system - urinary hesitation in children and adolescents; urinary retention in children and adolescents.
Psychiatric Side Effects
Early morning awakening, irritability, mood swings, Suicide-related events, aggression, hostility, emotional lability
Hostility (predominantly aggression, oppositional behaviour, and anger) and emotional lability were more frequently observed in clinical trials among children and adolescents treated with STRATTERA compared to those treated with placebo.
Patients who are being treated for ADHD should be carefully monitored for the appearance or worsening of suicide-related behaviour, hostility, and emotional lability. As with other psychotropic medication, the possibility of rare, serious psychiatric adverse effects cannot be excluded.
Users reports: from Ask a Patient web site
Related Informations/Articles
More information from Drugs.com web site
UK drug safety regulator the MHRA forbids Sweden to reveal Strattera suicide data 10th March 2006
Warnings
Growth and development should be monitored during treatment with atomoxetine. Patients requiring long-term therapy should be monitored and consideration should be given to dose reduction or interrupting therapy in patients who are not growing or gaining weight satisfactorily.
Clinical data do not suggest a deleterious effect of atomoxetine on cognition or sexual maturation, however, the amount of available long-term data is limited. Therefore, patients requiring long-term therapy should be carefully monitored.
Suicide warning issued USA 29 September 2005
The FDA directed Eli Lilly and Company (Lilly), the manufacturer of Strattera (atomoxetine), to revise the prescribing information to include a boxed warningand additional warning statements that alert health care providers of an increased risk of suicidal thinking in children and adolescents being treated with this medication.
FDA also informed Lilly thata Patient Medication Guide (MedGuide) should be provided to patients when Strattera is dispensed. The MedGuide advises patients of the risks associated with and precautions that can be taken when Strattera is dispensed. Further, pediatric patients being treated with Strattera 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 few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Read the complete MedWatch 2005 Safety Summary, including a link to the FDA Public Health
Be aware of interactions with other medicines..
Reporting Adverse Drug Reactions (ADRs)
If you have suffered psychiatric adverse reactions please report them. There may be side effects not mentioned on the data sheets. You can request a list of drugs used pre surgery and during surgery. You should be given patient information for all drugs prescribed as you are discharged from hospital.
Please report Adverse Drug Reactions (ADRs) to:
UK Yellow Card Reporting for Patient and Health Professional reports of Adverse Drug Reactions
USA and worldwide to the Food and Drug Administration for Patients and Healthcare Professionals
Universal free, independent drug safety website - Rxisk
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