Drug Enquirer

NEWS AND FACTS ABOUT MEDICINES YOU TAKE

Strattera may cause serious mental health problems including suicidal thoughts and psychosis (seeing or hearing things that are not real) in children and teenagers.

ABOVE: Eli Lilly and Company, "Strattera Medication Guide," rev. 5/08.

Most people may not know that Strattera appears to cause unsatisfactory sexual function (decreased libido, ejaculatory problems and impotence). The long-term effects of Strattera are still unknown.

ABOVE: Eli Lilly and Company, "Strattera Medication Guide," rev. 5/08
Strattera
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.

Strattera Side Effects and Warnings

Used for

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.

WARNING:
SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS

STRATTERA (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of STRATTERA in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder.

Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of STRATTERA in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving STRATTERA compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials [see Warnings and Precautions (5.1)].

ABOVE: Eli Lilly and Company, Strattera Medication Guide, rev. 5/08.

Do Not Use Strattera If

Manufacturer's Safety Notice

Strattera is arguably safer than methylphenidate and certainly less addicting than amphetamines (Adderall and Vyvanse). Whether Strattera is as effective for ADHD as methylphenidate (Ritalin) is questionable, but many physicians feel it is worthwhile to try it first.

ABOVE: The Essential Guide to Psychiatric Drugs—Rev. and updated (2007).

Common Reactions to Strattera in children and teenagers

Common side effects to Strattera in adults

Serious Reactions to Strattera

Watch for the following signs in your child or teenager during STRATTERA treatment.

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
ABOVE: Eli Lilly and Company, “Strattera Prescribing Information,” rev 05/2017.

FDA Warning: Links Between ADHD Drugs and Priapism and Sexual Dysfunction

In a recent drug-safety announcement, the FDA announced that drugs containing methylphenidate must including warnings about the risk of priapism. (Methylphenidate drugs include: Concerta, Daytrana, Focalin, Metadate, Methylin, Quillivant, and Ritalin.) It's a serious problem: priapism is a persistent, usually painful, erection that lasts for more than four hours and occurs without sexual stimulation. If the condition is not treated immediately, it can lead to scarring and permanent erectile dysfunction.

The FDA included an even stronger warning about atomoxetine (Strattera): “Priapism appears to be more common in patients taking atomoxetine than in patients taking methylphenidate products. Health care professionals should be cautious when considering changing patients from methylphenidate to atomoxetine.”

The safety warning also raised concerns about links between priapism and amphetamine drugs, which include Adderall, Dexedrine, ProCentra and Vyvanse.

ABOVE: U.S. FDA Drug Safety Communication: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes. (12/17/2013).

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

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.

Abrupt cessation of Strattera or other changes in Strattera dosage (both decreases and increases) can result in suicidal thoughts or suicidal actions in children and teenagers.

ABOVE: Eli Lilly and Company, "Strattera Medication Guide," rev. 5/08.

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.

If you have taken a newly released medication, you, too, are part of the great ongoing clinical trial. When a new drug is approved less than half of its serious reactions are known. The FDA relies upon you, the consumer, to determine the other half.

ABOVE: Cohen, J.S. Over Dose: The Case Against the Drug Companies: Prescription Drugs, Side Effects, and Your Health. New York: Penguin Putnam Inc., 2001.

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.

Warnings from Drug Maker's Guide

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:

  • anxiety
  • agitation
  • panic attacks
  • trouble sleeping
  • irritability
  • hostility
  • aggressiveness
  • impulsivity
  • restlessness
  • mania
  • depression
  • suicide thoughts

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:

  • itching
  • right upper belly pain
  • dark urine
  • 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.
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