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There Should Be a Threshold Dose for the FDA Black-Box Warning on Droperidol

2003; Lippincott Williams & Wilkins; Linguagem: Inglês

10.1213/01.ane.0000077672.77618.22

1526-7598

Mark Dershwitz,

Cardiac electrophysiology and arrhythmias

To the Editor: In their consideration of the cases on which the FDA warning on droperidol was based, Habib and Gan (1) used 1.25 mg as the threshold dose and reported 10 cases in which droperidol supposedly caused a severe adverse cardiac event. In my earlier article on the same subject (2), I used 10 mg as the threshold dose and described in detail the 19 cases in the FDA database alleging severe droperidol-induced cardiac toxicity. Even when the more liberal threshold of 10 mg is used, there is an alternate and more plausible explanation for the etiology of each of the described events. There is no doubt that droperidol at larger doses can cause severe arrhythmias. In fact, if you are acutely psychotic, present to the emergency department of a European hospital, are given droperidol at doses of 25–100 mg, and are subsequently not monitored, you have cause for real worry. Many such cases are found within the FDA database and such cases are certainly what worried FDA officials. Conversely, droperidol given at the usual antiemetic doses is safe. A statement made by Hill et al. in 2000 (3) should still guide us today irrespective of what FDA might think about droperidol: “The use of 1.25 mg droperidol intravenously was associated with greater effectiveness, lower costs, and similar patient satisfaction compared with 0.625 mg droperidol intravenously and 4 mg ondansetron intrave- nously.” There should thus be a threshold dose, e.g., 5 or 10 mg, beyond which the stipulations of the black-box warning would apply. I believe our specialty has been too complacent in accepting FDA’s decision to not include a threshold dose in the black-box warning. In my article (2), I concluded by recommending that FDA “establish an independent ‘blue ribbon’ panel of anesthesiology and pharmacology experts to review independently the safety data on droperidol.” If enough members of our specialty write FDA (and perhaps our Congressional representatives as well), FDA might conceivably be convinced to act on our collective requests. Mark Dershwitz, MD, PhD