FDA ALERT [09/2005] Suicidal Thinking in Children and Teens

• Strattera may increase thoughts of suicide or suicide attempts in children and teens.
• Call your child’s healthcare professional right away if your child or teen has:
  • new or increased thoughts of suicide
  • changes in mood or behavior including becoming irritable or anxious

The label for Strattera is being revised to include the above warnings.

What Is Strattera?

Strattera is used to treat a condition called Attention-Deficit with Hyperactivity Disorder (ADHD) in children, teens, and adults. Strattera has not been studied in children under 6 years old.

Who Should Not Take Strattera?

You should not take Strattera if you:

• are taking a medicine called a Monoamine Oxidase Inhibitor (MAOI). Do not take Strattera for at least 2 weeks after you stop taking a MAOI. Do not take a MAOI for at least 2 weeks after you stop taking Strattera.

• have an eye disease called narrow angle glaucoma

What Are The Risks?

The following are the major potential risks and side effects of Strattera. However, this list is not complete.

The following are the major potential risks and side effects of Strattera therapy:

• Suicidal thoughts or actions: Strattera may increase thoughts of suicide or suicide attempts in infrequent cases. Call you doctor right away if you become irritable or anxious or have other mood changes, or if you have thoughts of suicide.
• Liver Damage: Strattera can cause liver damage in rare cases. Call your doctor right away if you have itching, dark urine, yellow skin or eyes, upper right-sided stomach area pain, or unexplained “flu-like” symptoms.
• Weight Loss/Slowed Growth: Some people may lose weight while being treated with Strattera. It is not known if growth will be slowed in children who use Strattera for a long time. Height and weight should be watched in children who are taking Strattera.
• Impaired Motor Skills: Do not drive or operate dangerous machines until you know how Strattera affects you.

Some common side effects that may occur with Strattera in children include:

• upset stomach
• decreased appetite
• nausea or vomiting
• dizziness
• tiredness
• mood swings

Some common side effects that may occur with Strattera in adults include:

• constipation
• dry mouth
• nausea
• decreased appetite
• dizziness
• problems sleeping
• sexual side effects
• problems urinating
• menstrual cramps

These are not all of the side effects reported with Strattera. Your healthcare professional can give you a more complete list of side effects.

What Should I Tell My Healthcare Professional?

Before you start taking Strattera, tell your healthcare professional if you:

• have or had liver problems. You may need a lower dose of Stattera.
• have high blood pressure. Strattera can increase blood pressure.
• have problems with your heart or an irregular heartbeat. Strattera can increase heart rate (pulse).
• have low blood pressure. Strattera can cause dizziness or fainting in people with low blood pressure.
• are trying to become pregnant, are already pregnant, or are breast-feeding.
• have a problem with depression or suicidal thinking.

Can other Medicines or Food Affect Strattera?

Strattera and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Strattera works or Strattera may affect how your other medicines work. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

Date created: September 29, 2005

FDA Alert [09/05]: Suicidal Thinking in Children and Adolescents

The Food and Drug Administration (FDA) directed Eli Lilly (Lilly) to revise the labeling for Strattera to include a boxed warning and additional warning statements regarding an increased risk of suicidal thinking in children and adolescents being treated with this drug. In addition, a Medication Guide will be prepared to provide directly to patients, their families, and caregivers information about the risks mentioned above. The Medication Guide is intended to be distributed by the pharmacist with each prescription or refill of a medication.
Strattera is currently approved in the United States to treat ADHD in children, adolescents, and adults. Strattera has not been studied in children under 6 years of age.

Recommendations

 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.  This monitoring should include daily observation by families and caregivers and frequent contact with the physician.

Data Summary

The increased risk of suicidal thinking for this drug in children and adolescents was identified in a combined analysis of 12 short-term (6-18 weeks) placebo-controlled trials (11 in ADHD and 1 in enuresis).  These 12 trials involved a total of over 2200 patients, including 1357 receiving Strattera and 851 receiving placebo.  The analysis showed a greater risk of suicidal thinking during the first few months of treatment in those receiving Strattera.  The average risk of suicidal thinking was about 4 per thousand patients treated with Strattera compared to no events in placebo-treated patients.  There was 1 suicide attempt among these approximately 2200 patients, occurring in a patient treated with Strattera.  A similar analysis in adult patients treated with Strattera for either ADHD or major depressive disorder (MDD) found no increased risk of suicidal ideation or behavior with the use of Strattera.

Date created: September 29, 2005