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Pseudo-Emergent Use of an Investigational Drug

Section Editor(s): Saidman, LawrenceRosman, Edwin J. MD

doi: 10.1213/01.ane.0000268702.75645.c0
Letters to the Editor: Letters & Announcements
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Department of Anesthesiology; North Shore University Hospital; Manhasset, New York; Erosmanmd@optonline.net

The FDA does not wish to respond.

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To the Editor:

I am disturbed by the publication of a case report (1) involving the emergency use of the investigational drug, sugammadex, in a patient without prior informed consent in an attempt to “rescue” him from residual neuromuscular blockade. The accompanying editorial defines an emergency when the “subject is confronted by a life threatening situation” and “there is available no alternative method of approved … therapy that provides an equal or greater likelihood of saving the life of the subject” (2); This case clearly was not an emergency and conventional treatment would be to continue ventilation and sedation until neuromuscular function recovers. Another ethical problem was that the “pseudo emergency” was iatrogenic. An intermediate-lasting muscle relaxant (vecuronoium) dependent on liver metabolism and renal excretion was administered for a relatively short procedure (peritoneal dialysis catheter placement) to a patient with kidney failure.

Fortunately for the investigators, the patient had a good outcome. With every new drug, there are increased risks for unknown side-effects. The patient could have suffered anaphylaxis, recurarization, or possible end-organ damage.

The authors failed to meet the standards for emergency use of nonapproved FDA drugs as described in the accompanying editorial. The hospital's IRB should have not given permission for the use of sugammadex in this setting. Anesthesia & Analgesia should have not published this article.

Edwin J. Rosman, MD

Department of Anesthesiology

North Shore University Hospital

Manhasset, New York

Erosmanmd@optonline.net

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REFERENCES

1. Lenz A, Hill G, White PF. The 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