MY SYNOPSIS ONFDA Orders Stronger Warning Labels on Child Antidepressants
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The FDA has decided that all antidepressants should come in a black box with labels. Included in the package, an easy-to-read pamphlet that explains how to decide if a child is a candidate for the drug and what the warning signs of suicide are. In this article, it states that the FDA should consider the extra step of making parents sign a form that they understand the risks of the medication, before their child will receive the first pill. Dr. Wayne Goodman, FDA advisory committee chairman stated, "It will make prescribing more difficult, I anticipate there will be alarm from parents and the child." "I think that's worth that complication, because it will raise the threshold to prescribing these drugs to minors," he concluded.
"On the other hand, the drugs seem to help some desperately ill children," says panelist Jean Bronstein, a California nurse. "The biggest message I heard from the consumer is they want to be warned about what the risk is." The FDA isn't obligated to their advisers' recommendations, but it usually listens to them, and has indicated its willingness to update the outdated warnings on today's antidepressant labels. Furthermore, they stated that the link between antidepressants and suicidal behavior has not been proven...