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Anesthesiology:
doi: 10.1097/ALN.0b013e31816d810f
Correspondence

The Black Box Warning for Droperidol

Sosis, Mitchel B. M.S., M.D., Ph.D.

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To the Editor:—

I read with interest the recent article and accompanying editorial regarding the black box warning on the package insert for droperidol.1,2 Nuttall et al.2 indicate that droperidol is a safe, effective, and inexpensive antiemetic and that the black box warning on the package insert is not needed. In addition, they seem to believe that their use of droperidol is prevented by the presence of the boxed warning.2
I was surprised that according to their study,2 the use of droperidol completely stopped after the addition of the black box warning. In contrast, midazolam, succinylcholine, and ketorolac all have black box warnings and still appear to be widely used by anesthesiologists.3 Furthermore, the presence of a black box warning on a medication's package insert is not the same as the withdrawal of a medication, so clinicians are still able to use it if they choose to.
In view of the events surrounding the withdrawal of rofecoxib (Vioxx)4 and other medications,5 the US Food and Drug Administration should make every effort to protect patients from drugs that may be dangerous and to alert physicians of these dangers.
At my institution, antiemetics other than droperidol seem to be adequate for the prevention or treatment of postoperative nausea and vomiting, so we are to able to get along without droperidol. Moreover, ondansetron is now available as a generic medication, so this alternative to droperidol should be cheaper.6
Mitchel B. Sosis, M.S., M.D., Ph.D.
Holy Redeemer Hospital and Medical Center, Meadowbrook, Pennsylvania. mitchelsosis@hotmail.com
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References

1. Charbit B, Funck-Brentano C: Droperidol-induced proarrhythmia: The beginning of an answer? Anesthesiology 2007; 107:524–6

2. Nuttall GA, Eckerman KM, Jacob KA, Pawlaski EM, Wigersma SK, Marienau ME, Oliver WC, Narr BJ, Ackerman MJ: Does low-dose droperidol administration increase the risk of drug-induced QT prolongation and torsade de pointes in the general surgical population? Anesthesiology 2007; 107:531–6

3. Sosis MB: Package inserts are a must read for anesthesiologists. Anesthesiology 2006; 104:1106

4. Greener M: Drug safety on trial: Last year's withdrawal of the anti-arthritis drug Vioxx triggered a debate about how to better monitor drug safety even after approval. EMBO Rep 2005; 6:202–4

5. Sosis MB: Further comments on the withdrawal of rapacuronium. Anesth Analg 2002; 95:1126–7

6. First generic of Zofran. FDA Consum 2007; 41:6

© 2008 American Society of Anesthesiologists, Inc.

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