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.