TThis is
a summary of the most important information about Strattera. For
more information, talk to your healthcare professional.
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.
This information reflects FDA’s current
analysis of data available to FDA concerning this drug. FDA
intends to update this sheet when additional information or
analyses become available.
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.
Questions? Call Drug Information, 1-888-INFO-FDA
(automated) or 301-827-4570
druginfo@fda.hhs.gov