Infused Local Anesthetics Information

[November 13, 2009]: The Food and Drug Administration (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 post-surgical pain. The significance of this injury to otherwise healthy young adults warrants notification to health care professionals.

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.

Chondrolysis was diagnosed within a median of 8.5 months after the infusion.  Almost all of the reported cases of chondrolysis (97%) occurred following shoulder surgeries. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).

It is not known which specific factor or combination of factors contributed to the development of chondrolysis in these cases. The infused local anesthetic drugs, the device materials, and/or other sources may have resulted in the development of chondrolysis.  It is important to note that single intra-articular injections of local anesthetics in orthopedic procedures have been used for many years without any reported occurrence of chondrolysis.

Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics.

Health care 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.

Based on the reported cases of chondrolysis, following continuous intra-articular infusion with local anesthetics, the FDA is requiring the drug manufacturers to update their product labels to warn healthcare professionals about this potential serious adverse effect. In addition, the FDA will require the manufacturers of pumps that may be used to infuse local anesthetics, including elastomeric infusion devices, to have similar warnings for their products.

The FDA is requiring the changes to the drug label under the authorities granted by the Food and Drug Administration Amendments Act (FDAAA) of 2007.

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

To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program using the information at the bottom of the page.