Unexpected cardiovascular deaths are rare with therapeutic doses of droperidol.
In December 2001, the FDA required a "black box warning" suggesting that unexpected cardiovascular deaths could occur at normal therapeutic doses of droperidol. We reviewed data from 270 MedWatch reports, including 99 reports of death, submitted between November 1, 1997, and January 10, 2002. We further reviewed primary reports of deaths and cardiovascular adverse events associated with < or = 10 mg of droperidol. There were 99 death reports representing 89 patients, with a specified dose in 66 cases. Among 74 (83%) foreign fatality reports, 57 included a known dose (> or = 50 mg in 29 cases [49%] and < or = 2.5 mg in only 3 cases [5%]). Of the 15 (17%) U.S. cases, 9 included a specified dose (< or = 2.5 mg in 5 cases and 5-10 mg in 4 cases). Cardiovascular deaths after therapeutic doses (< or = 2.5 mg) of droperidol are rare. Mandatory electrocardiographic screening appears unnecessary.
Mullins
Michael
M
Barnes-Jewish Hospital, Washington University School of Medicine, St. Louis, Missouri 63110, USA. mullinsm@wustl.edu
Van Zwieten
Krista
K
Blunt
Jeffrey R
JR
D000932:Antiemetics / Q000009:adverse effects* / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000139:chemically induced*; D004305:Dose-Response Relationship, Drug; D004329:Droperidol / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D020250:Postoperative Nausea and Vomiting / Q000517:prevention & control; D014481:United States; D014486:United States Food and Drug Administration
D000932:Antiemetics; D014150:Antipsychotic Agents; D004329:Droperidol