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Where's the Fire?

Section Editor(s): Saidman, LawrenceWax, David MD

doi: 10.1213/01.ane.0000268706.67403.61
Letters to the Editor: Letters & Announcements

Mount Sinai School of Medicine; New York, New York

The FDA does not wish to respond.

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To the Editor:

In their case report, Lenz et al. (1) detailed emergency use of sugammadex for a patient with residual neuromuscular blockade. As an investigational drug, sugammadex use is limited to approved clinical trials. FDA regulations also permit its use in life-threatening situations for which no alternative therapy is available (2). It does not appear, however, that such a situation existed in this case.

In a center without immediate availability of sugammadex, a tracheally intubated patient with acute respiratory distress secondary to residual neuromuscular blockade would be provided with mechanical ventilatory assistance and sedation as needed. Although sugammadex has been extensively tested and appears both safe and effective, the use of an investigational therapy in an emergency situation instead of a readily available, highly effective, standard-of-care alternative seems imprudent. Had the trachea already been extubated, a case could be made about the relative risks of sugammadex versus reintubation, but that was not the scenario as described. Even after sugammadex is approved for general use, its potentially high cost may demand careful consideration of its value for routine use.

The outcome was good and we appreciate the authors sharing their experience and additional data about the drug's efficacy and safety with us. Still, we must be very careful in our judgment and selective in our use of our authority as physicians to declare an emergency and thereby eliminate the need for informed consent, as well as in using new therapies in the place of older, better-proven ones.

David Wax, MD

Mount Sinai School of Medicine

New York, New York

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1. Lenz A, Hill G, White PF. Emergency use of sugammadex after failure of standard reversal drugs. Anesth Analg 2007;104:585–6
2. Schultheis LW, Rappaport BA. The Food and Drug Administration perspective: use of an investigational drug in a medical emergency. Anesth Analg 2007;104:479–80
© 2007 International Anesthesia Research Society