Inside the black box: current policies and concerns with the United States Food and Drug Administration's highest drug safety warning system.
OBJECTIVE
To evaluate the United States Food and Drug Administration use of the black-box warning system to promote drug safety and to examine the droperidol black-box warning as a case study.


RESULTS
Scientific studies report that there is no basis to issue a black-box warning for perioperative administration of droperidol for postoperative nausea and vomiting on the basis of the potential of adverse cardiac events (prolongation of the QT interval and/or development of torsades de pointes).


CONCLUSIONS
Rather than relying on well conducted clinical investigations, the Food and Drug Administration subjectively issued a black-box warning to droperidol, which effectively removed droperidol from clinical practice for the indication of postoperative nausea and vomiting. Newer data suggest that the incidence of prolongation of the QT interval and the occurrence of torsades de pointes is similar to more expensive alternative medications used to treat postoperative nausea and vomiting.
Halloran
Kylene
K
Greenwich Hospital, Greenwich, Connecticut, USA
Barash
Paul G
PG
D016907:Adverse Drug Reaction Reporting Systems; D000932:Antiemetics / Q000009:adverse effects; D001145:Arrhythmias, Cardiac / Q000139:chemically induced; D003257:Consumer Product Safety; D004329:Droperidol / Q000009:adverse effects; D017277:Drug Approval; D004348:Drug Labeling; D006291:Health Policy; D006801:Humans; D008133:Long QT Syndrome / Q000139:chemically induced; D020250:Postoperative Nausea and Vomiting / Q000517:prevention & control; D016171:Torsades de Pointes / Q000139:chemically induced; D014481:United States; D014486:United States Food and Drug Administration
D000932:Antiemetics; D004329:Droperidol