Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, depression, and suicidal ideation, especially early during STRATTERA treatment and when the dose is adjusted. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Patients initiating STRATTERA should be cautioned that liver dysfunction may develop rarely. Patients should be instructed to contact their physician immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms.

Patients should be instructed to call their doctor as soon as possible should they notice an increase in aggression or hostility.

STRATTERA is an ocular irritant. STRATTERA capsules are not intended to be opened. In the event of capsule content coming in contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any potentially contaminated surfaces should be washed as soon as possible.

Patients should consult a physician if they are taking or plan to take any prescription or over-the-counter medicines, dietary supplements, or herbal remedies.

Patients should consult a physician if they are nursing, pregnant, or thinking of becoming pregnant while taking STRATTERA.

Patients may take STRATTERA with or without food.

If patients miss a dose, they should take it as soon as possible, but should not take more than the prescribed total daily amount of STRATTERA in any 24-hour period.

Patients should use caution when driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected by atomoxetine.

What is the most important information I should know about STRATTERA?

Parents or guardians need to think about 4 important things when their child/teenager is prescribed STRATTERA:

1. There is a risk of suicidal thinking

2. How to try to prevent suicidal thoughts or actions in your child

3. You should watch for certain signs if your child is taking STRATTERA

1. There is a Risk of Suicidal Thinking

Children and teenagers sometimes think about suicide, and many report trying to kill themselves.

STRATTERA increased suicidal thinking in some children being treated for ADHD in clinical trials.

A large study combined the results of 12 different studies of children and teenagers with ADHD. In these studies, patients took either a placebo (sugar pill) or STRATTERA for 6 to 18 weeks. No one committed suicide in these studies, but some patients experienced suicidal thinking. On sugar pills, no patients developed suicidal thinking. On STRATTERA, 4 out of every 1000 patients developed suicidal thinking.

For some children and teenagers, the risks of suicidal thinking or behaviors may be especially high. These include patients with

· Bipolar illness (sometimes called manic-depressive illness)

· A family history of bipolar illness

· A personal or family history of attempting suicide

If any of these are present, make sure you tell your healthcare provider before your child takes STRATTERA.

2. How to Try to Prevent Suicidal Thoughts and Actions

To try to prevent suicidal thoughts and actions in your child, talk with and listen to your child about his or her thoughts and feelings and pay close attention to changes in his or her moods or actions, especially if the changes occur suddenly. Other important people in your child’s life can help by paying attention as well (e.g., brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3.

Whenever STRATTERA is started or its dose is changed, pay close attention to your child.

After starting STRATTERA, your child should generally see his or her healthcare provider:

· Once a week for the first 4 weeks

· Every 2 weeks for the next 4 weeks

· After taking STRATTERA for 12 weeks

· After 12 weeks, follow your healthcare provider’s advice about how often to come back

· More often if problems or questions arise (see Section 3)

You should call your child’s healthcare provider between visits if needed.

3. You Should Watch for Certain Signs If Your Child is Taking STRATTERA

Contact your child’s healthcare provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child’s teacher:

· Thoughts about suicide or dying

· Attempts to commit suicide

· New or worse depression

· New or worse anxiety

· Feeling very agitated or restless

· Panic attacks

· Difficulty sleeping (insomnia)

· New or worse irritability

· Acting aggressive, being angry, or violent

· Acting on dangerous impulses

· An extreme increase in activity and talking

· Other unusual changes in behavior