The Food and Drug Administration (FDA) is notifying health care professionals of reports of a serious and destructive cartilage condition known as chondrolysis in patients who have had shoulder surgery during which they received continuously infused local anesthetics to deaden pain. The anesthetics were delivered via pain pumps, balloon-like devices that hold medication outside the body and have a catheter that delivers pain medication directly into the shoulder joint for up to 72 hours following surgery.
It is not known whether the drugs or the device is causing the chondrolysis, or if it is a combination of several factors. However, reports of the debilitating shoulder condition have skyrocketed in the past few years since pain pump devices were used in this fashion.
Chondrolysis is a serious condition that causes pain and loss of motion. Some patients may require joint replacement surgery. Many of the patients who have developed chondrolysis following shoulder repair surgery were adolescents or young adults.
In the patient safety announcement, the FDA is reminding health care professionals that use of local anesthetics in pain pump devices is not an approved use, and the FDA is requiring makers of local anesthetics to update the labeling of these drugs to include a warning of the risk of chondrolysis. Similar warnings will also be placed on pain pump devices.
Source: FDA Patient Safety Notice