The FDA has received several reports of chondrolysis after continuous intra-articular infusions of local anesthetics with elastomeric infusion devices.

Between 2006 and 2008, the agency received 35 reports of cartilage necrosis and destruction among healthy, young patients given such treatment to control postsurgical pain.

The FDA emphasized that local anesthetics are approved as injections and don’t include an indication for continuous intra-articular postoperative infusions or for use with infusion devices.

“Healthcare professionals are encouraged 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,” the FDA said.

The 35 cases reported to the FDA’s Adverse Events Reporting System (AERS) occurred mainly in otherwise healthy young adults, who were a median age of 25 years and ranged from ages 16 to 58.

Anesthetics were infused for extended periods of time — 48 to 72 hours — using elastomeric pumps.

Almost all of the cases — 97% — occurred after shoulder surgeries.

Chondrolysis was diagnosed within a median of 8.5 months after the infusion, with some symptoms — such as joint pain, stiffness, and loss of motion — occurring as early as two months postinfusion.

In more than half of the cases, patients required additional surgery, including arthroscopy or arthroplasty.

The FDA said it is not sure which factor or combination of factors contributed to the development of chondrolysis.

Overall, 91% of patients received bupivacaine (with or without epinephrine) as the infusion, with two of these cases also receiving ropivacaine.

Two of the 35 cases received bupivacaine as a single injection along with an intra-articular infusion of lidocaine.

Half of the bupivacaine-associated cases reported the dose administered: 10 of 16 patients received 500 mg over 48 hours, or 250 mg/day. That falls within the maximum dose listed on the drug label (400 mg/day), the FDA said, but these parameters were determined for approved uses, not off-label uses.

The agency said the events don’t seem to be associated with any single manufacturer. It has since received four additional reports of chondrolysis in patients given intra-articular infusions of lidocaine in the shoulder, after the initial 35 reports.

The FDA emphasized that “single intra-articular injections of local anesthetics in orthopedic procedures have been used for many years without reported cases of chondrolysis.”

However, it has required drug manufacturers and device makers to update their product labels to warn healthcare professionals about these potential serious adverse effects.

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