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Executive Summary

ROCHE VERSED (MIDAZOLAM) LOWER SURGICAL DOSE for at-risk patients was suggested by FDA's Anesthetic and Life Support Drugs Advisory Committee at its Dec. 1-2 meeting. During discussion of Versed adverse reactions, the panel generally agreed that a lower Versed dose is advisable for patients who may be at risk. Committee member Casey Blitt, MD, Old Pueblo Anesthesia, Ltd, said "dose recommendations for midazolam should be widened or broadened particularly in the down side range." FDA told the committee that it has received a total of 28 "serious" Versed adverse reactions reports since the drug was launched in March of this year. Seventeen of the serious adverse reactions reported were from domestic sources, FDA said. FDA Epidemiology and Surveillance Division Janet Arrowsmith suggested to the committee that the dose, "although within the accepted range of the package insert (0.035-0.35), may have been excessive given that the patient were elderly, somewhat debilitated and received concomitant anti-depressants." FDA staffer Paula Botstein, MD, said that the information in the reports "is sometimes extremely scanty . . . very hard to know whether use of drug was causal with the outcome . . . [but] we may be seeing a signal that is a very real signal." The major side effect of midazolam is cardio-respiratory depression which increases when it is used with other anti-depressants, Arrowsmith said. She noted that 8% of the adverse effects reported during the April through August period were considered by the agency to be "serious" reactions, which compares with a 4% "serious" adverse reaction rate for McNeil's Zomax (zomepirac) before it was withdrawn from the market. The patients mentioned in the reports were mostly female, with the mean age of 63-64 years, and medical histories of cardiovascular disease, arrhythmias, strokes, hypertension and alcoholism. Out of the 12 patients whose outcome was reported, nine died of cardiac or respiratory arrest or a combination of both, while two patients experienced aspiration and regurgitation. The agency indicated that it would try to "clarify how the dose should be reduced in various disease states." A representative from Roche proposed that new informational approaches be applied to the problem, including "Dear Doctor" letters, videotapes, and teleconferences. Among the possible changes in the labeling, he recommended that doses could be individualized and that a caution recommending advance preparation of resuscitation facilities and continuous monitoring of the patient be included. Another area under consideration by the committee was the epidural use of steroids for the treatment of lower back pain. Stephen Abram, MD, Medical College of Wisconsin, reported to the committee that although epidural use of steroids was not approved for labeling, its use in the treatment of lower back pain, particularly sciatica, is now common. Several committee members advised that full scale multicenter studies would be helpful in more specific targeting of a patient population and in determining the relative safety of particular preparations. However, it was noted that steroid manufacturers are not likely to sponsor such studies nor seek labeling approval for the epidural indication.

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