Local Anesthetics, Continuously Infused (bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) : Chondrolysis reported with continuous intra-articular infusions via elastomeric infusion devices

FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Fri, 13 Nov 2009 15:04:51 -0600

Title: Local Anesthetics, Continuously Infused (bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) : Chondrolysis reported with continuous intra-articular infusions via elastomeric infusion devices

Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis

Audience: Orthopedic and Anesthesia healthcare professionals, hospital risk managers

FDA notified healthcare professionals of 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 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. 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).

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.

This notice provides further management considerations for healthcare professionals, information for patients, a data summary of the 35 reports, and references.

Read the complete MedWatch 2009 Safety summary, including a link to the Information for Healthcare Professionals sheet, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190496.htm

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