FDA has reviewed 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control postsurgical pain. The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump.

It is not known which specific factor or combination of factors contributed to the development of chondrolysis in these cases. Based on these reported cases, FDA is requiring drug manufacturers to update their product labels to warn healthcare professionals about this potential serious adverse effect.

Healthcare professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.

This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.