Sentences with phrase «strong black box warning»
The FDA has required the maker of Depakote to include a strong black box warning alerting doctors and patients to the potential for life - threatening side effects associated with Depakote use including serious birth defects such as anencephaly (brainless babies) and spina bifida.
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In October federal health officials announced that antidepressants must carry a black box label — the Food and Drug Administration's strongest warning — indicating the drugs can cause suicidal behavior in children and teenagers.