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Nutrilib.com
A comprihensive source of nutritional information
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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. 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, Pediatric Use).
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STRATTERA SUMMARY
STRATTERA®(atomoxetine HCl)
STRATTERA® (atomoxetine HCl) is a selective norepinephrine reuptake inhibitor.
STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
The effectiveness of STRATTERA in the treatment of ADHD was established in 2 placebo-controlled trials in children, 2 placebo-controlled trials in children and adolescents, and 2 placebo-controlled trials in adults who met DSM-IV criteria for ADHD ( see CLINICAL STUDIES).
A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, "on the go," excessive talking, blurting answers, can't wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met.
The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.
STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.
The effectiveness of STRATTERA for long-term use, ie, for more than 9 weeks in child and adolescent patients and 10 weeks in adult patients, 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 ( see DOSAGE AND ADMINISTRATION).
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STRATTERA NEWS HIGHLIGHTS Media Articles Related to Strattera (Atomoxetine)
ADHD in Children: Side Effects of Strattera
Source: MedicineNet atomoxetine Specialty [2006.12.13]
ADHD: TAU Develops A Driver's Safety Program To Increase Road Safety And Save Lives
Source: ADHD News From Medical News Today [2008.11.04]
Published Studies Related to Strattera (Atomoxetine)
Acute atomoxetine treatment of younger and older children with ADHD: A meta-analysis of tolerability and efficacy. [2008.09.15]
Abuse liability assessment of atomoxetine in a drug-abusing population. [2008.05.01]
Atomoxetine for the treatment of attention-deficit/hyperactivity disorder and oppositional defiant disorder. [2008.02]
A pilot study of adjunctive atomoxetine treatment to second-generation antipsychotics for cognitive impairment in schizophrenia. [2008.02]
Atomoxetine improved response inhibition in adults with attention deficit/hyperactivity disorder. [2007.11.01]
Clinical Trials Related to Strattera (Atomoxetine)
A Clinical Trial to Examine Effects of Atomoxetine in the Treatment of Negative Symptoms in Patients With Schizophrenia [Completed]
Atomoxetine and Huntington's Disease [Active, not recruiting]
Strattera Treatment in Children With ADHD Who Have Poor Response to Stimulant Therapy [Completed]
Effects of Atomoxetine on Cognitive Function in Schizophrenia [Completed]
Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar [Completed]
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STRATTERA PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 5 ratings/reviews, Strattera has an overall score of 5.40. The effectiveness score is 6.40 and the side effect score is 5.60. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Strattera review by 21 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | ADHD |
| Dosage & duration: | | 10mg taken 1/day for the period of 8 days |
| Other conditions: | | IDDM |
| Other drugs taken: | | insulin | | |
Reported Results |
| Benefits: | | none |
| Side effects: | | visual disturbances, weight gain, insomnia, anxiety, hyperglycemia, headaches, mild hallucinations, water retention, difficulty concentrating, memory lapses, erratic behaviour. these side effects lasted for several weeks after I stopped taking the medication, and my vision did not return to normal for almost a month. my doctor said it was an anti-cholinergic reaction. |
| Comments: | | i started at a very low dose, to be worked up gradually. treatment ended before this could happen. |
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| | Strattera review by 40 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | ADULT ADD |
| Dosage & duration: | | 10mg, 20mg, taken daily for the period of 1 yr |
| Other conditions: | | high blood pressure |
| Other drugs taken: | | lysinopryl | | |
Reported Results |
| Benefits: | | I was much more awake in the mornings instead of groggy and foggy -brained. I was able to focus a LITTLE bit better |
| Side effects: | | Blurry vision, increased bladder leaks,moodiness, a little weight gain which may not be from Strattera |
| Comments: | | Unfortunately I had a doctor who was uneducated about ADD and was very uncomfortable prescribing any medications for it. She put me on 10mg first.After 3-4 weeks I went back and asked for her to increase it. She prescribed 20mg,(which I found they don't make 20mg doses) Instead of changing it to a proper mg, she decided to have me take 2 10mg pills every morning which also doubled the cost and that amount was not enough to have much benefit. After about a year , I was finally prescribed a therapeutic dosage of 40mg. I had too many problems with the pharmacy ordering the right amount ( they had me take 4 10mg pills a day because they didn't order the right ones! I have no health insurance so was getting it on some program that made it cost me $6 but when they would screw up the order , I would either run out or have to get the full amount which was $130.00 at the 10mgs, so X 2 for 20mg, x 4 for 40mgs!! Just because of the way the pharmacy was doing it.Scamming the federal programs or something...so I finally just quit taking it. I definately had noticed that it made pee without barely any warning, and my eyesight got alot worse, and my fiance said it made me "mean". All that has stopped now that I am not on it. But my ADD is back full force! |
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| | Strattera review by 55 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | ADD |
| Dosage & duration: | | 40mg 1-2x/day taken 1/day for the period of 2 years |
| Other conditions: | | none |
| Other drugs taken: | | primpro | | |
Reported Results |
| Benefits: | | Treatment benefits include improved attention to task, improvement in work quality and quantity. Impulsivity was greatly reduced, resulting in a calmer more productive day. Social relationships with co-workers and others were markedly improved. Social relationships with extended family members were also improved. As a result there was a marked improvement in self esteem and confidence levels both at work and at home. |
| Side effects: | | There wer few side effects. I experienced intermittent episodes of dry mouth that interferes when during public speaking, speaking at meetings and in social situations. This can be resolved with small candies, however, that resulted in tooth decay. I am currently trying out a gel and mouthwash given to me by my dentist, however, I am not happy about putting these chemicals in my mouth. |
| Comments: | | I am not sure what you want in this section. I received counseling. Medication was suggested. Other more typical, stimulant medications were tried but produced anxiety. This is a newer non-stimulant medication, and that is a plus. I have continued counseling and periodic check-ups with the prescribing physician. I am pleased with the results and plan on continuing with this treatment. |
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Page last updated: 2008-11-04
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