Chondrolysis occurs when the cartilage in the shoulder joint wears away causing bone to rub against bone. The onset of symptoms, which includes joint pain, stiffness and loss of motion, can vary but may begin as early as the second month following surgery. There is no effective treatment for chondrolysis, and many patients who suffer from the condition require total shoulder replacement therapy.

The local anesthetics that now carry the warning include Carbocaine (Mepivacaine HCl), Marcaine (bupivacaine HCl), Naropin (ropivacaine HCl), Nesacaine (chloroprocaine HCl), Nesacaine-MPF (chloroprocaine HCl), and Xylocaine (lidocaine HCl).

The manufacturers of pain pump devices that hold the local anesthetics and infuse them into the joint space are also facing criticism for instructing surgeons to use the pain pumps to deaden pain following shoulder surgery, a use that was not approved by the FDA.

SOURCE: Pain Pumps › Local anesthetics add warning to label; risk of chondrolysis

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