The recent controversy regarding succinylcholine and the remote possibility of hyperkalernia as a result of undiagnosed myopathy was fueled, in part, by German reports from Dr. Schulte-Sasse of succinylcholine-related cardiac arrest. German anesthesiologists are now faced with probable label revisions similar to those which occurred in the United States and Canada (see related article). The German equivalent of the Food and Drug Administration is the Bundesinstitut fur Arzneimittel und Medizinalproduckte, known as the BIAM. The BIAM intends to prescribe a change in the labeling of succinylcholine to the manufacturers of this drug who offer it for sale in Germany. A translation of the proposed label change is as follows:
“Because of the severity of the adverse effects (intractable cardiac arrests in children with myopathy) it is recommended that also in apparently
healthy children and adolescents, the use of succinylcholine be restricted to emergency situations, in which immediate intubation and securing of the airway is mandatory.”
In this context the word “recommended” has a very similar meaning to the term ‘contraindicated’ as used in the U.S., according to Professor J. Link of the Freie Universitat Berlin.
The proposed label change has prompted responses from the German Society of Anesthesiology and Intensive Care Medicine (DGAI) and practicing German anesthesiologists. The BIAM also has an advisory committee similar to the U.S.’s Anesthetic and Life Support Drug Advisory Committee (ALSAC) which advised the FDA. This advisory committee is named Commission ‘A’ and advises the BIAM regarding the approval of new drugs and the reevaluation of approved drugs. The BIAM can reach decisions opposite that of Commission ‘A’ and Commission “A” has no veto power. Academic physicians and experts in various medical disciplines comprise the membership of this Commission. The BIAM itself answers to the Minister of Health. A new “Committee for Proprietary Medicinal Products’ has recently been formed (by the Commission of the European Community) and may end up resolving any differences that may arise between the pharmaceutical manufacturers and the BIAM.
Obviously, the resolution of the succinylcholine controversy will be at least as complicated in Germany as it was in the United States. It will be interesting to follow the developments and to see if the German situation will result in package insert language similar to that adopted in Canada and the U.S.
Dr. Morell of Bowman-Gray School of Medicine in Winston-Salem, NC, is a member of the APSF Newsletter Editorial Board and author of several Newsletter articles on the succinylcholine controversy.