Droperidol Since 2001 FDA Risk Assessment. Anesthetic and Life Support Drugs Advisory Committee November 18, 2003 Nancy Chang, M.D. Lead Medical Officer Division of Anesthetic, Critical Care and Addiction Drug Products. Center for Drug Evaluation and Research.
Anesthetic and Life Support Drugs
November 18, 2003
Nancy Chang, M.D.
Lead Medical Officer
Division of Anesthetic, Critical Care and
Addiction Drug Products
Center for Drug Evaluation and Research
Droleptan medicinal products will be discontinued from 31 March 2001…. This action has been taken by … Janssen-Cilag Ltd, who has chosen to voluntarily discontinue Droleptan following an extensive risk-benefit assessment. The company concluded that the oral formulations should be discontinued to prevent use in chronic conditions and that the injectable form would no longer be commercially viable. The Medicines Control Agency (MCA) had raised concerns about the potential effect of droperidol on the cardiac QT interval and requested the risk-benefit assessment.
---MCA, Jan 2001
22 cases, at least 5 fatal
60 yo F
Droperidol 0.625 mg for nausea, had QT interval prolongation
52 yo M, Transjugular intrahepatic PSS; 6/10/94
IV Droperidol 1.25 mg 10:30, SR
1.25 mg 11:26, SR w/ PVC’s
1.25 mg 12:06, SR
Procedure complete 15:06, to unit 16:30
19:15 Torsades, VF, then cardiac arrest, successfully defibrillated x2 (200, 300J), no evid ischemia, expired 6/18 unrelated
PMH: ETOH, cirrhosis/ascites, varices, Tob, COPD
Meds: Gent/Vanco, fent 550 mg total, versed 4mg total, KCl 40mEq, heparin 3000U IV
median QTc increases: 37, 44, 58 msec
ICU 5-20 mg/hr, QTc 400=>476; 437=>560
What is the denominator?
Polling - what is the right question?
15% with 1 episode VT postop (to 3-4 d)
6.3% periop V dysrhyth
1:532 periop mortality (232 deaths/2 yrs)
0.2% incidence cardiac arrests (144 cases)
Clinicians don’t practice according to labeling.
How to convey new information that may call for changes in practice?