FDA warns of chondrolysis risk with unapproved use of local anesthetics
November 16th, 2009 by Jennifer Walker-Journey
The Food and Drug Administration (FDA) is warning orthopedic and anesthesia health care providers and hospital risk managers not to continuously infuse local anesthetics directly into the intra-articular joint space because this use of anesthetics has led to a painful and debilitating condition known as chondrolysis, or the decaying and destruction of the cartilage.
On Friday, the FDA notified health care professionals of 35 reports of chondrolysis in patients who received regular infusions of the anesthetics for up to 72 hours following surgery. In the reported cases, the anesthetics were used with pain pump devices in which the medication was fed through a catheter that was placed directly into the joint space. The catheter was attached to a balloon that rested outside the body and was filled with the anesthetics.
These pain pump devices, often used with shoulder surgery, were approved by the FDA with the catheter placed in the shoulder tissue, not the joint space. But in the early 2000s, pain pump manufacturers began advising doctors to place the catheters directly into the joint space even though that use was not approved by the FDA. The constant drip of medication into the joint caused the serious breakdown of cartilage known as chondrolysis. Currently, patients who have been injured by the pain pump devices have filed suit against the manufacturers of pain pumps.
The anesthetics listed in the FDA notice include bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine. These 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.
The FDA is encouraging healthcare professionals 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.