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Succinylcholine chloride product labeling

Executive Summary

FDA Anesthetic & Life Support Drugs Advisory Committee will meet June 9 at 8:30 a.m. to discuss the labeling of short-acting muscle relaxant succinylcholine products marketed by Burroughs Wellcome (Anectine), Abbott Labs (Quelicin), Bristol-Myers Squibb (Sucostrin) and Organon. The committee may be revisiting its November 1992 suggestion to include a warning about the possibility of cardiac arrest in children with Duchenne's muscular dystrophy ("The Pink Sheet" Nov. 30, 1992, p. 11). The committee also will discuss occurrence of loss of sensation and motor function due to possible nerve damage associated with administration of Astra's Xylocaine-MPF 5% lidocaine injection with glucose 7.5% for spinal anesthesia. On June 10, from 8 to 9 a.m., the panel will be presented with a progress report on studies of the metabolism of lidocaine by human liver tissues. Closed committee deliberations will follow. The meeting will take place at FDA's Parklawn Building, conference rooms D & E

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