Astra USA Naropin safety data includes 218 C-section, 220 labor and delivery patients.
Executive Summary
ASTRA USA NAROPIN DATA INCLUDE EIGHT C-SECTION, NINE L&D SAFETY STUDIES, which were presented at a Dec. 12 Anesthetic & Life Support Drugs Advisory Committee review of the neuromuscular blocker ropivacaine. Astra USA presented data from eight studies performed in 218 Cesarean section patients receiving doses up to 150 mg of ropivicaine .5% concentration and nine studies of 220 labor and delivery patients receiving .25% ropivacaine. "The Pink Sheet" (Dec. 18, 1995, p. 7) incorrectly reported that Naropin safety data for use in pregnant women were derived exclusively from animal studies.
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ASTRA USA NAROPIN DATA INCLUDE EIGHT C-SECTION, NINE L&D SAFETY STUDIES, which were presented at a Dec. 12 Anesthetic & Life Support Drugs Advisory Committee review of the neuromuscular blocker ropivacaine. Astra USA presented data from eight studies performed in 218 Cesarean section patients receiving doses up to 150 mg of ropivicaine .5% concentration and nine studies of 220 labor and delivery patients receiving .25% ropivacaine. "The Pink Sheet" (Dec. 18, 1995, p. 7) incorrectly reported that Naropin safety data for use in pregnant women were derived exclusively from animal studies. In response to questions posed by primary reviewers, the committee voted unanimously that sufficient safety and efficacy data were presented by Astra USA to warrant an approval recommendation for Naropin. The panel also agreed that Astra had adequately demonstrated the relative cardiotoxicity of ropivacaine as compared to bupivacaine, but wanted further retrospective human studies to be conducted. The committee recommended that Astra conduct additional studies examining ropivacaine in obstetrical/C-section procedures. A warning label recommending the use of lower concentrations of Naropin in C-section patients was agreed upon by the committee. FDA Reviewer Philip Larson, University of California-Los Angeles School of Medicine, said: "I would suggest that we tell physicians what we do know -- we do know that [the] .5% concentration works -- and then we could tell them what we don't know -- we don't know whether higher doses are either necessary or safe." He added: "It may be necessary to have higher concentrations, higher dosages, but the safety data [for higher concentrations are] not available." Astra revised the warning label to state that Naropin be recommended at .5% solution for C-section patients and to warn of the risks of cardiac arrhythmias, cardiac/circulatory arrests and death for pregnant patients when inadvertently rapidly injected with I.V. bupivacaine. The advisory committee accepted the revision. |