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    Psychiatric adverse drug events prominent in certain drugs prescribed for kids

    During 2008-2012, more than 45,600 adverse drug events in children less than 18 years of age were reported to the FDA. Approximately 29,000 ADEs (64%) were serious, causing injury. During the 5-year period, the reports increased at a steady rate, from more than 6,300 in 2008 to 11,400 in 2012.

    Of these ADEs, 15 drugs were responsible for 41% of the serious ADEs, including three drugs for attention deficit hyperactivity disorder (ADHD), three antipsychotic drugs, and two biological agents used for rheumatoid arthritis and inflammatory bowel disease, according to the current ISMP’s QuarterWatch report.

    “Among serious adverse drug events (ADEs), psychiatric side effects were prominent for 10 of the 15 drugs, including suicidal behaviors, hallucinations, aggression, and mood change,” reported the QuarterWatch team—Thomas J. Moore, Curt D. Furberg, MD, PhD, Donald R. Mattison, MD, MS, and Michael R. Cohen, RPh, MS.

    The three ADHD drugs that were prescribed to children and caused psychiatric side effects were lisdexamfetamine (Vyvanse), methylphenidate (Concerta), and atomoxetine (Strattera). Suicidal ideation was the most frequently reported specific symptom with these medications.

    Atomoxetine, an antidepressant, has a suicidal behavior warning like other antidepressants, the authors noted. However, lisdexamfetamine and methylphenidate don’t carry a suicidal behavior warning. Suicidal behaviors were reported by 26.4% who experienced an ADE with lisdexamfetamine, by 18.1% who had reported an ADE with atomoxetine, and by 13.9% who reported an ADE with methylphenidate.

    “FDA should assess the need for a warning for the more frequently reported suicidal thoughts and behaviors,” they said.

    Of the antipsychotic drugs causing psychiatric side effects in kids, suicidal behaviors were reported by 10.4% on aripiprazole (Abilify), 18.5% on risperidone (Risperdal), and 24.8% on quetiapine (Seroquel). Other ADEs associated with these antipsychotic medications included dyskinesias, neuroleptic malignant syndrome, dystonia, lactation disorders, gynecomastia, weight increase, diabetes, and convulsions, according to the report.

    “Despite these high risks, the reports indicated that antipsychotic drugs were given to children for a wide range of disorders, including depression, ADHD, aggression, and sleep disorders,” the authors noted.

    Psychiatric effects were also seen in children who took montelukast (Singulair) for asthma and allergies as well as isotretinoin for severe acne. Reports of suicidal behavior, aggression, depression, crying, and mood swings were noted with the use of montelukast. Reports of suicidal behaviors, unintended pregnancies, depressed mood, and colitis were seen with isotretinoin.

    Other ADEs

    Infliximab (Remicade) and etanercept (Enbrel)—two anti-TNF agents—were reported to result in serious ADEs, such as gastrointestinal problems with the former agent and infusion site reactions with the latter. “The results in both children and adults continue to show that anti-TNF agents are high-risk treatments requiring vigilance in their use,” the authors said.

    Reports of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, were reported with the use of lamotrigine (Lamictal) and ibuprofen.

    “The FDA’s required Boxed Warning notes that the rates of SJS/TEN appear to be higher in children than in adults [for lamotrigine], and less severe rashes may appear in 10% of treated patients. Its first-line use as adjunctive therapy for seizures should be reevaluated, and its approved use for maintenance in bipolar disorder reconsidered,” they wrote.

    “Reports of SJS/TEN associated with ibuprofen were instrumental in pushing the reported serious adverse event totals for ibuprofen higher than other mostly over-the-counter pain medications used in children, acetaminophen and naproxen,” the QuarterWatch team said.


    Julia Talsma, Content Channel Director
    Julia Talsma is lead editor for Drug Topics magazine.


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