The notice to patients was part of a recent announcement by the FDA warning health care professionals of the a painful and debilitating condition known as chondrolysis reported in patients who have had surgery followed by continuously infused local anesthetics for 48 to 72 hours through a pain pump device. The anesthetics involved are marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine.

While the local anesthetics are approved by the FDA 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 pain pump devices, or elastomeric pumps.

Chondrolysis was diagnosed within a median of 8.5 months after infusion. Almost all of the reported cases (97 percent) 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, also known as joint replacement.

The numerous reported cases of chondrolysis following use of intra-articular infusion with local anesthetics has prompted the FDA to require the drug manufacturers to update their product labels to warn healthcare professionals about the potential serious adverse effect.

SOURCE: Pain Pumps › Orthopedic surgery patients urged to monitor symptoms

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.

SOURCE: Pain Pumps › FDA warns of chondrolysis risk with unapproved use of local anesthetics