Important Safety Information for Strattera
What is the most important information I should know about Strattera?
Suicidal thoughts and actions in children and teenagers:
Children and teenagers sometimes think about suicide, and many report trying to kill themselves. In some children and teens, Strattera increases the risk of suicidal thoughts or actions. Results from Strattera clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions. Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Call the doctor right away if your child or teenager has thoughts of suicide or sudden changes in mood or behavior, especially at the beginning of treatment or after a change in dose. Strattera is not approved for major depressive disorder.
Tell your child/teenager’s doctor if your child/teenager has (or if there is a family history of) bipolar illness (manic-depressive illness) or suicidal thoughts or actions before starting Strattera. Call your child or teenager’s doctor right away if they develop new psychological symptoms such as abnormal thoughts/behaviors and/or extreme elevated or irritable moods while taking Strattera.
Strattera can cause liver injury in some patients. Call your doctor right away if you or your child has itching, right upper belly pain, dark urine, yellow skin or eyes, or unexplained flu-like symptoms.
Heart-related problems have been reported with Strattera. Sudden death has been reported in patients who have heart problems or heart defects. There have also been reports of stroke and heart attack in adults, and increased blood pressure and heart rate. Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting Strattera. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Strattera.
Who should not take Strattera?
Strattera should not be taken if you or your child:
- Are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. You or your child/teenager should also not take an MAOI within 14 days of stopping Strattera. This is to avoid a life-threatening condition.
- Have an eye problem called narrow angle glaucoma.
- Are allergic to anything in Strattera.
- Have or have had a rare tumor called pheochromocytoma.
What should I tell my doctor or my child’s doctor before taking Strattera?
Strattera may not be right for you or your child. Before starting Strattera, tell your doctor or your child’s doctor about all health conditions (or a family history of) including:
- Have or had suicidal thoughts or actions
- Heart problems, heart defects, irregular heart beat, high blood pressure, or low blood pressure
- Mental problems, psychosis, mania, bipolar illness, or depression
- Liver problems
- If you or your child is pregnant, planning to become pregnant, or breastfeeding
What other important information should I know about Strattera?
Serious allergic reactions have occurred in patients taking Strattera. Call your doctor if you or your child has trouble breathing, swelling, hives, or experience other allergic reactions.
Talk to your healthcare provider if your child experiences slowing of growth (height and weight). Children should have height and weight checked often while taking Strattera, and your healthcare provider may stop Strattera treatment if a problem is found during these checkups.
Patients taking Strattera have experienced problems passing urine, including trouble starting or keeping a urine stream, and not being able to fully empty the bladder.
Erections that won't go away (priapism) have occurred rarely during treatment with Strattera. If you or your child/teenager has an erection that lasts more than 4 hours, seek medical help right away.
Strattera may affect your ability or your child’s ability to drive or operate heavy machinery. Be careful until you know how Strattera affects you or your child/teenager.
Tell your doctor about all the medicines that you or your child takes, including prescription and nonprescription medicines, vitamins, and herbal supplements. Strattera and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether Strattera can be taken with other medicines.
What are the common possible side effects of Strattera?
Common side effects in children and teenagers include upset stomach, decreased appetite, nausea or vomiting, dizziness, tiredness, and mood swings.
Common side effects in adults include constipation, dry mouth, nausea, decreased appetite, dizziness, sexual side effects, and problems passing urine.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Strattera is available by prescription only.
Please see Prescribing Information, including boxed warning regarding suicidal thoughts and actions in children and teenagers, and Medication Guide.
AT Con ISI 27Sep2013