FDA Issues Suicide Warning on Strattera

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.

Strattera Side Effects and Warnings

• Generic name: Atomoxetine Hydrochloride (atomoxetine HCl)
• Brand name: Strattera

Strattera (atomoxetine) is Used for

Officially used for attention-deficit/hyperactivity disorder (ADHD), Strattera is also used as an augmenting agent to boost the effectiveness of standard antidepressents.

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

• Mood swings
• Tiredness
• Dizziness
• Nausea or vomiting
• Decreased appetite
• Upset stomach

Common side effects to Strattera in adults

• Sexual dysfunction (decreased libido, ejaculatory problems, impotence)
• Constipation
• Dry mouth
• Nausea
• Decreased appetite
• Dizziness
• Insomnia (trouble sleeping)
• Menstrual cramps
• Problems passing urine

Serious Reactions to Strattera

• Suicidal thoughts and actions in children and teenagers. Watch for the following signs in your child or teenager during STRATTERA treatment:
• anxiety
• agitation
• panic attacks
• trouble sleeping
• irritability
• hostility
• aggressiveness
• impulsivity
• restlessness
• mania
• depression
• suicide thoughts
• 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
• Severe liver damage
• 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
• Serious allergic reactions (call your doctor if you see swelling, hives, or experience other allergic reactions)
• Slowing of growth (height and weight) in children
• Problems passing urine including:
• Trouble starting or keeping a urine stream
• Cannot fully empty the bladder

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.

Dosage Forms of Strattera (atomoxetine HCl)

EACH STRATTERA CAPSULE CONTAINS ATOMOXETINE BASE OF:
10 mg	18 mg	25 mg	40 mg	60 mg	80 mg	100 mg
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

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.

Sexual Dysfunction:	STRATTERA	PLACEBO
Erectile disturbance (males only)	7%	1%
Impotence (males only)	3%	0%
Orgasm abnormal (both males and females)	2%	1%

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.

New Medications: 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.

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