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Impact of the FDA Black Box Warning on Physician Antidepressant Prescribing and Practice Patterns: Opening Pandora's Suicide Box

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  • Practical suicide-risk management for the busy primary care physician

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    For a much more detailed review of antidepressant use in primary care, see the June 2010 issue of Mayo Clinic Proceedings.54 The 2004 US Food and Drug Administration (FDA) BBW for “suicidality” in patients taking antidepressants confused the public, prescribers, and patients.55 The BBW was based on reported increases in drug-related suicidal ideation or behaviors, defined as “suicidality,” compared with placebo.

  • Change in use of gadolinium-enhanced magnetic resonance studies in kidney disease patients after US Food and Drug Administration warnings: A cross-sectional study of veterans affairs health care system data from 2005-2008

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    There are limited data for how FDA warnings and required changes in product information affect the use of therapeutic and diagnostic agents. An analogous situation occurred when the FDA issued warnings of antidepressants potentially worsening depression and increasing suicidality in children and adolescents.18 The FDA released a public health advisory cautioning about the use of antidepressants in children and adolescents in March 2004, followed by a black box warning on all antidepressants marketed in the United States in October 2004.19

  • Health care consequences of black-box warnings for antidepressants in the United States and Canada

    2010, Research in Social and Administrative Pharmacy
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    The findings suggest that providers were cautious in using antidepressants following the black-box warning in children as intended by the FDA. A recent survey conducted by the Mayo Clinic found that these warnings had more pronounced effects on generalists involved in pediatric care than specialists.22 Over 80% of generalists involved in pediatrics reported decreased usage of antidepressants compared with 8% of psychiatrists.22

  • Selective serotonin re-uptake inhibitor warnings and trends in exposures reported to poison control centres in Texas

    2008, Public Health
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    The question might be raised regarding why the declines in paroxetine and other SSRI use after the various FDA advisories were not even greater than what was observed. A potential explanation is that adverse drug event warnings are not always heeded.29–31 Healthcare providers may not consider the risk to be that great, especially for their particular patient.

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Funding for this study was provided by the Mayo Clinic Department of Psychiatry and Psychology.

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