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Executive Summary

FDA REQUESTING VERSED DISTRIBUTION AND USE INFORMATION to assist in the agency's evaluation of Health Research Group's petition to relabel the anesthetic. In a March 22 letter to Roche, FDA Center for Drug Evaluation and Research Deputy Director Paula Botstein, MD, asked that the firm provide the data on Versed (midazolam) "as soon as possible" to "aid in our evaluation of the issues raised by the [HRG] petition." The HRG petition, submitted Feb. 12, requests the agency to demonstrate that recent reductions in Versed dosage recommendations have not compromised effects of the agent, such as anterograde amnesia, and if the effects have been compromised, to relabel the product to highlight the change ("The Pink Sheet" Feb. 22, p. 11). Recommended dosage levels for Versed have been reduced twice since the product was approved in May 1986. HRG's petition maintains that Roche studies in Britain have shown a decrease in the amnesia effect at the lower doses. The petition asserts that despite lowered dosages, the product possesses a narrow safety margin and should be contraindicated in patients over 60 years old "due to body composition differences and increased sensitivity in this population." The petition also requests that Versed be contraindicated for use in conscious sedation "due to the lack of adequate cardiorespiratory monitoring in settings where conscious sedation occurs." FDA is asking Roche to provide distribution and use data on different strengths of Versed by age and by indication. The agency, however, is not requesting any information regarding the agent's efficacy in producing anterograde amnesia. Specifically, the agency is asking Roche to provide: "Total amount of drug distributed since marketing approval, by calendar year;" "Breakdown of drug distribution by packing configurations for the 5 mg/ml formulation and the 1 mg/ml formulation;" "Estimates of drug use by indication, i.e., induction, conscious sedation, other pre-operative sedation (including unapproved uses);" "Estimates of drug use by patient age in ten-year increments and by age and sex." Roche said it is still evaluating the FDA's letter, but that it intends to "cooperate fully" with the agency's request.

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