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Executive Summary

ROCHE's VERSED CLEARED OF LACK OF EFFECTIVENESS REPORTS, after FDA's Therapeutic Inequivalency Action Coordinating Committee's (TIACC) investigation turned up "no specific basis" for the reports. On Nov. 15 the committee issued a summary analysis of alleged lack of effectiveness of the injectable midazolam product in Tele-ject dosage form. TIACC's report concludes: "The firm has taken precautions to monitor the drug product; the records indicate that there is no specific basis as to the reported incidence of alleged therapeutic failures." Versed is a central nervous system depressant used for conscious sedation and for general anesthesia as an adjunct with other anesthetic agents. TIACC said FDA's Product Surveillance Branch had received "several" Product Problem Reports alleging lack of effectiveness "after patients were administered Versed in the Tele-ject dosage form." TIACC subsequently requested a follow-up on the reports. FDA's district office in Newark visited Roche to "determine how many complaints have been received by the firm"; review the "investigational follow-up...conducted by the firm for each problem report; review the firm's production/release records for each lot involved in the problem reports; and determine the firm's assessment of these types of problems." Investigation of the company began in May and was completed in June, the report notes. FDA's "review of the firm's files indicate that 84 complaints" regarding potency and effectiveness were received, TIACC's report states. "If available, a sample of the medication in question was obtained and analyzed," TIACC noted. "There were no cases on record where a returned sample was found to be subpotent." Roche said it suspects that the reports of lack of effectiveness are a result of patients being given too low a dose of Versed. The dose has to be carefully titrated according to a patient's reaction to the drug, the company noted. Public Citizen's Health Research Group submitted a petition to FDA in February 1988 requesting that the agency contraindicate use of Versed in the elderly and in conscious sedation because of reports of deaths attributed to cardiorespiratory depression in patients receiving Versed. The petition also asserts that reduced dosage recommendations for Versed have compromised its efficacy compared to diazepam (Roche's Valium) and that diazepam is a safer agent. However, FDA has testified that Versed has clinical advantages over diazepam, including superior anesthetic effect and usefulness as a preanesthetic agent.



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