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ROCHE VERSED ADMINISTERED TO MORE THAN 10 MIL. PATIENTS

Executive Summary

ROCHE VERSED ADMINISTERED TO MORE THAN 10 MIL. PATIENTS in the U.S., according to estimates by the manufacturer. First marketed domestically in March 1986, the sedative has been "associated" with 31 deaths in the U.S. as of Dec. 1, according to Roche. In a Dec. 23 press advisory, the firm said the number of associated deaths constitutes "approximately one patient in 322,580 (0.0003%)." An additional 29 deaths have been reported outside the U.S. "These domestic and foreign reports include cases of suicide and otherwise severely compromised patients, for example with severe trauma or cardiorespiratory problems," Roche asserted. Additional reports of 70 deaths (four domestic and 66 foreign) were made during clinical trials. "In most of the clinical trial cases, the patients were severely compromised, and the investigators did not consider the deaths to be drug related," the company said. "Examples of patients receiving the drug in these situations includes those in critical care settings and others with status epilepticus and renal failure." The press advisory added: "It is important to note that the term 'associated' as used in the context of the U.S. FDA regulations covers adverse experiences 'whether or not drug related.'" The information contained in the press advisory constitutes a summary of data the company is submitting to Rep. Weiss (D-N.Y.), chairman of the House Government Operations/Intergovernmental Relations Subcommittee, as part of his oversight of recent FDA approvals of drugs with narrow safety margins. Roche said Weiss requested "information about the U.S. and international experience 'relating to deaths associated with worldwide use of midazolam during clinical investigations and postmarketing experience.'" Versed has been mentioned in recent news reports that noted adverse experiences with the product. Weiss' interest in the Versed approval was disclosed in his subpoena of FDA records on five drugs in November ("The Pink Sheet" Nov. 23, p. 6). In addition, Roche announced during the last week in November that it added a boxed warning to Versed's labeling to caution that I.V. midazolam "has been associated with respiratory depression and respiratory arrest, especially when used for conscious sedation." The warning states that Versed therefore should be administered "only in hospital or ambulatory care settings, including physicians' offices, that provide for continuous monitoring of respiratory and cardiac function." Roche enclosed copies of the new labeling in letters to 500,000 physicians. The letter cautions that "serious adverse events, including respiratory depression, apnea, cardiac arrest, and death have been associated with" Versed administration.
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