Pediatric News - Strattera
Strattera (atomoxetine HCl, Eli Lilly & Co.)
The Food and Drug Administration approved Strattera for attention-deficit/hyperactivity disorder maintenance therapy in children and adolescents aged 6 years and older. This is the first FDA-approved agent for maintenance treatment of ADHD.
* Recommended Dosage: The recommended maintenance dosage is 1.2 mg/kg per day to 1.8 mg/kg per day for children aged 6-15 years who have responded to initial treatment with the agent. See package labeling for acute treatment dosages and specific instructions per patient’s weight.
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* Special Considerations: Closely monitor pediatric patients for suicidality, clinical worsening, and unusual changes in behavior, especially during the initial few months of a course of Strattera therapy or at times of dosage changes, according to a black box warning on the labeling.
Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence were the most common adverse reactions in children and adolescents treated with Strattera up to 18 weeks in clinical trials.
Strattera can cause severe liver injury in rare cases and should be discontinued in patients with jaundice or laboratory evidence of liver injury.
Reports of sudden death associated with atomoxetine have been reported in children and adolescents with structural cardiac abnormalities or other serious heart problems. In addition, the agent can increase blood pressure and heart rate, and should be used with caution in patients who have hypertension, tachycardia, or cardiovascular or cerebrovascular disease.
Also, atomoxetine can cause the emergence of psychotic or manic symptoms (hallucinations, delusional thinking, or mania, for example) in children and adolescents with no history of psychotic illness or mania.
* Comment: Maintenance efficacy is based on an outpatient study of patients aged 6-15 years. Children with formally diagnosed ADHD who demonstrated continuous response for 4 weeks during an initial 10-week, open-label trial with 1.2-1.8 mg/kg per day of Strattera were assessed further. In all, 292 participants were randomized to continue the initial Strattera regimen and 124 others were randomized to placebo and monitored for relapse. Researchers then studied those treated with Strattera who showed approximately 8 months of continuous response. Of these, 81 were randomized again to continue the regimen while another 82 were randomized to placebo. Participants who took Strattera throughout the study had significantly longer times to ADHD relapse, compared with participants taking placebo.
The approval “is helpful and reassuring to families,” Dr. Barry Sarvet said in an interview. “The more we can have a validation of FDA approval for child psychiatry indications, the more comfortable everyone can feel.”
“The benefit will be in our communication with parents when obtaining informed consent,” Dr. Mohab Hanna said. “The reassurance will be especially relevant to parents since Strattera has only been available on the market since late 2002.” Dr. Hanna is a board-certified child and adolescent psychiatrist in Lutherville, Md.
“We’ve always considered ADHD to be a chronic mental health issue that requires long-term treatment,” said Dr. Sarvet, chief of child and adolescent psychiatry at Baystate Health Systems in Springfield, Mass. However, “The approval for maintenance therapy will most likely not alter the clinical management of ADHD for most physicians … since most physicians are already treating ADHD on a long-term regimen,” said Dr. Hanna, who specializes in the treatment of ADHD in children and adolescents.
Children and adolescents on Strattera should be monitored every 2-3 months, he said in an interview. Dr. Hanna and Dr. Sarvet have no financial disclosure related to Strattera or Eli Lilly & Co.
“The research shows that [Strattera] really does work, but its effects tend to be more subtle than stimulants,” said Dr. Sarvet, who is also on the psychiatry faculty at Tufts University, Boston. “For some patients, it’s a great choice. For patients with more significant impairment, it may be more appropriate to start treatment with a stimulant. There is some controversy, but most of us consider Strattera to be a second-line drug. There is a larger body of research on the effects of stimulants.”
Dr. Hanna agreed: “Strattera can be an option for some patients, especially for children or adolescents who suffer from anxiety disorders or tic disorders, but for most other patients, stimulants are still the first choice, especially in patients who are hyperactive or impulsive,” he said.
BY DAMIAN McNAMARA, MIAMI BUREAU
COPYRIGHT 2008 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning
