Chondrolysis with Continuously Infused Local Anesthetics

FDA is notifying healthcare professionals about chondrolysis in patients receiving continuous intra-articular infusion of local anesthetics to treat post-surgical pain. FDA has received a number of reports of cartilage necrosis and destruction in these patients, nearly all of whom received the infusions in the shoulder. Many of the patients were otherwise-healthy adolescents and young adults. As a result of the cartilage damage, some of them required additional surgery, including joint replacement.

In these procedures, the local anesthetic was administered with an elastomeric pump over a period of 48 to 72 hours. At this point, it is not known which characteristics of the infusions may be causing the problem - whether it is the drug itself, the materials in the infusion device, or some combination of factors. It is important to note that single intra-articular injections have been used in orthopedic procedures for many years without reports of chondrolysis.

FDA is reminding healthcare professionals that local anesthetics are not approved for intra-articular infusions, or for use in infusion devices like elastomeric pumps. Because of the chondrolysis reports, FDA is requiring the manufacturers of local anesthetic drugs to specifically warn against this use in the products' labeling. A similar warning will be required for elastomeric pumps.

FDA Patient Safety News: February 2010

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=95#4

Category:

Education

Tags:

• Intra-articular infusion
• pain medicine
• shoulder surgery
• joint replacement
• elastomeric pump
• FDA