The FDA pediatric advisories and changes in diagnosis and treatment of pediatric depression. data

摘要

Extensive debate about the safety of antidepressants for pediatric anxiety and mood disorders began when the U.K. Medicines and Healthcare Products Regulatory Agency advised on June 10, 2003, that paroxetine not be prescribed for anyone under 18 (9). On June 19, 2003, the U.S. Food and Drug Administration (FDA) issued a statement recommending that paroxetine not be used for treating pediatric depression. The FDA requested that pharmaceutical companies submit suicidality data from pediatric antide-pressant clinical trials. In August 2003, Wyeth voluntarily changed labels for pediatric -use venlafaxine and issued a "Dear Health Care Provider" letter indicating that higher rates of hostility and suicidality had been reported for pediatric patients treated with venlafaxine in clinical trials. After an initial review of pediatric antidepressant clinical trials, the FDA issued a public health advisory on October 27, 2003, indicating that current data suggested an association between antidepressants and suicidality in pediatric patients treated for depression.