Local anesthetics add warning to label; risk of chondrolysis
March 16th, 2010 by Jennifer Walker-Journey
Several local anesthetics have added warnings on their labels notifying health care professionals that using the drugs in intra-articular devices, or pain pumps, following arthroscopic and other surgical procedures is not approved and has been linked to cases of a painful and debilitating condition of the shoulder joint known as chondrolysis, according to the Food and Drug Administration (FDA) Drug Safety report for February 2010. The cases of chondrolysis were reported in both pediatric and adult patients following intra-articular infusions of the anesthetics with and without epinephrine, a hormone neurotransmitter, for 48 to 72 hours following surgery.
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.