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ROCHE's VERSED (MIDAZOLAM) REVISED LABELING

Executive Summary

ROCHE's VERSED (MIDAZOLAM) REVISED LABELING that calls for lower dosage in elderly or debilitated patients adequately addresses adverse reaction concerns, FDA's Anesthetic & Life Support Drugs advisory committee agreed at its meeting May 19. The committee had recommended a lower surgical dose for at-risk patients at its last meeting in December. Roche Associate Director for Drug Regulatory Affairs Karen Church reported that since December the Versed package insert has been revised to state that the initial dose for chronically ill or debilitated patients is "approximately 1 to 1.5 mg," a 50% reduction from the previous indication. The labeling also states that: "the total dose should be lowered by a total of 55-60% in elderly or debilitated patients receiving a narcotic or CNS depressant premedication." Labeling previously stated that dosage "should be lowered by about 25% to 30% if narcotic medication is used" and that patients 60 years or older may require lower doses "by about 30%" than younger patients. In additional revisions, a statement has been added in boldface that "when used for conscious sedation, Versed should not be administered by rapid or single bolus I.V. administration." For average healthy adults, the total recommended dose is now 0.1 mg/kg; it was previously 0.1 to 0.15 mg/kg. The recommendation that "in rare cases, a total dose of up to 0.2 mg/kg may be necessary" has been deleted from the labeling. The labeling also adds that in titrating dose to individual needs a dose lower, i.e. lower than 0.1 mg/kg total dose, may suffice. Church noted that FDA has also approved a 1 mg/ml formulation that Roche will launch following receipt of a final approval letter. Versed is currently available in package configurations equivalent to 5 mg/ml. In addition, Church said Roche disseminated a "Dear Doctor" letter the first week in February that "reemphasized the need for individualization of dose; the proper methods for administering the drug intravenously, the need for early recognition and treatment of under ventilation and apnea; and reinforced the possibility of respiratory and cardiac events." Roche's James Braico reported that from April 1986 until March 1987 there have been 48 cases reported of apnea, cardiopulmonary events and/or death (23 cases). Church concluded that based on Roche's analysis of available data the company "does not believe that dosage per se, ASA status, or age, per se, is an adequate predictor of cardiovascular or respiratory adverse events." However, Church stated that a reduction of dosage in elderly and in patients who have a narcotic or CNS premedication "is essential."
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