FDA Advisors Skeptical of Liposomal Bupivacaine for Regional Pain Control
An FDA advisory committee voted 6-4 against expanding approved indications for liposomal bupivicaine for regional pain control after surgery. This drug is a central element in many institutions' Enhanced Recovery After Surgery programs. They cited inconsistent results, failure to provide comparative results, and increased deaths associated with the drug. The official FDA will use this assessment as part of their deliberations.
This is concerning. I have had high hopes for this drug. Anecdotal reports from surgical colleagues have been positive. Many have trouble getting on the shelf due to cost concerns, but it appears the FDA has raised safety and efficacy concerns as well.
We retrospectively looked at this in comparison to bupivacaine in saline in VATS patients. While the data was not perfectly clean, we did not notice a clear advantage in terms of narcotic requirements, lengths of stay and outcome.