The long term effects of Strattera are still unknown. Considered by the FDA as Phase IV of a clinical trial, the early years in the marketplace are when the drug is really put to the test, treating a diverse cross-section of the population.
Officially used for attention-deficit/hyperactivity disorder (ADHD). Strattera is also used as an augmenting agent to boost the effectiveness of standard antidepressants.
FDA "Black Box" Warning
The Food and Drug Administration (FDA) requires the following "black box" warning on Strattera (atomoxetine hydrochloride) which means that medical studies indicate these drugs carry a significant risk of serious, or even life-threatening, adverse effects.
Do Not Use Strattera If
you have or had suicide thoughts or actions
you have heart problems, heart defects, irregular heart beat, high blood pressure, or low blood pressure
you have mental problems, psychosis, mania, bipolar illness, or depression
you have liver problems
you are pregnant, planning to become pregnant, or breastfeeding
you have an eye problem called narrow angle glaucoma
do not combine with a monoamine oxidase inhibitor
Manufacturer's Safety Notice
Strattera can exacerbate mood swings; important to note if you have Bipolar disorder
Common Reactions to Strattera in children and teenagers
EACH STRATTERA CAPSULE CONTAINS ATOMOXETINE BASE OF:
Opaque White, Opaque White
Gold, Opaque White
Opaque Blue, Opaque White
Opaque Blue, Opaque Blue
Opaque Blue, Gold
Opaque Brown, Opaque White
Opaque Brown, Opaque Brown
ABOVE: Eli Lilly and Company, “Strattera Prescribing Information,” rev 05/2017.
Male and Female Sexual Dysfunction with Strattera—unsatisfactory sexual experience
Strattera appears to impair sexual function in some patients. Changes in sexual desire, sexual performance, and sexual satisfaction are not well assessed in most clinical trials because they need special attention and because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of unsatisfactory sexual experience and performance cited in product labeling are likely to underestimate the actual incidence. The table below displays the incidence of sexual side effects reported by at least 2% of adult patients taking Strattera in placebo-controlled trials.
Erectile disturbance (males only)
Impotence (males only)
Orgasm abnormal (both males and females)
There are no adequate and well-controlled studies examining sexual dysfunction with Strattera treatment. While it is difficult to know the precise risk of sexual dysfunction associated with the use of Strattera, physicians should routinely inquire about such possible side effects.
If Strattera Does Work
In addition to known possible life-threatening side effects which include sudden death in children and adolescents, Strattera can can impair your thinking and reactions, especially highlighted if you drive or do anything that requires you to be awake and alert. Both you and those living around you should be alert for changes in mood or symptoms. Especially watch for signs of depression or thoughts of hurting yourself or thoughts of suicide.
Strattera is not designed for long-term use. ADHD, however, may be a long-term condition. Thus, the drug manufacturer says the physician's decision to use Strattera should be as a part of a total treatment program for ADHD that may include counseling or other therapies.
If Strattera Doesn't Work
When used for ADHD, if Strattera doesn't work, the next stronger drug is usually used instead, generally one of the versions of methylphenidate (Ritalin).
Long-Term Use of Strattera
Since it's a new medication (released in 2002), the long-term effects of Strattera are unknown.
The effectiveness of Strattera for long-term use, i.e. for more than 9 weeks in children and teenagers and 10 weeks in adults, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Strattera for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
FDA Issues Suicide Warning on Strattera
as reported by Associated Press (September 29, 2005)
The FDA directed Eli Lilly and Company, the manufacturer of Strattera (atomoxetine), to revise the prescribing information to include a boxed warning and additional warning statements that alert health care providers of an increased risk of suicidal thinking in children and adolescents being treated with this medication.
The FDA also informed Lilly that a 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 Strattera therapy, or at times of dose changes, either increases or decreases.
Are You a Drug Guinea Pig?
Drug companies have realized the enormous demand for psychiatric medications and are actively working on many new ones. When
a manufacturer brings out a new drug, they advertise it aggressively. However, pre-marketing trials, performed to satisfy the FDA requirements for new drugs, test at most a few thousand people in a very structured environment.
The FDA considers the first years in the marketplace as Phase IV of a clinical trial because that's when the drug is really put to the test, treating a diverse cross-section of the population.
All pediatric patients being treated with Strattera should be monitored closely for suicidal thoughts or suicidal actions, clinical worsening, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes.
What is the most important information I should know about STRATTERA?
The following have been reported with use of STRATTERA:
1. Suicidal thoughts and actions in children and teenagers:
Children and teenagers sometimes think about suicide, and many report trying to kill themselves. 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. Tell your child or teenager's doctor if your child or teenager (or there is a family history of):
has bipolar illness (manic-depressive illness)
had suicide thoughts or actions before starting STRATTERA
The chance for suicidal thoughts and actions may be higher:
early during STRATTERA treatment
during dose adjustments
Prevent suicidal thoughts and action in your child or teenager by:
paying close attention to your child or teenager's moods, behaviors, thoughts, and feelings during STRATTERA treatment
keeping all follow-up visits with your child or teenager's doctor as scheduled
Watch for the following signs in your child or teenager during STRATTERA treatment:
Call your child's or teenager's doctor right away if they have any of the above signs, especially if they are new, sudden, or severe. Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.
2. Severe liver damage:
STRATTERA can cause liver injury in some patients. Call your doctor right away if you or your child has the following signs of liver problems:
right upper belly pain
yellow skin or eyes
unexplained flu-like symptoms
3. Heart-related problems:
sudden death in patients who have heart problems or heart defects
stroke and heart attack in adults
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.
Your doctor should check your blood pressure or your child's blood pressure and heart rate regularly during treatment with 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.
4. NEW mental (psychiatric) problems in children and teenagers:
new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms
Call your child or teenager's doctor right away about any new mental symptoms because adjusting or stopping STRATTERA treatment may need to be considered.
ABOVE: Eli Lilly and Company, “Strattera Medication Guide,” rev. 5/08 and 07/08.
Although Vyvanse is referred to as “pro-drug” of dextroamphetamine, it's still an amphetamine, meaning that it's easily abused and can cause insomnia, agitation, anxiety and sometimes psychotic symptoms like seeing things or becoming paranoid. [More]
Many think methylphenidate (Ritalin) is safe, or mild, because so many children use it. However, the government classifies the psychoactive drug with cocaine and morphine because it's highly addictive. [More]
Gorman, Jack M. The Essential Guide to Psychiatric Drugs—Rev. and updated, 4th ed. New York, NY: St. Martin's Press, 2007.
Cohen, J.S. Over Dose: The Case Against the Drug Companies: Prescription Drugs, Side Effects, and Your Health. New York: Penguin Putnam Inc., 2001.
Drummond, E.H. The Complete Guide to Psychiatric Drugs: Straight Talk for Best Results, Rev. and expanded. New Jersey: John Wiley & Sons Inc., 2006.
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