Alerts

Chondrolysis Reported With Continuous Intra-articular Infusions of Local Anesthetics - November 2009

The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals and patients of the recent reporting of 35 cases of chondrolysis following continuous intra-articular infusion of local anesthetics (eg, bupivacaine, chloroprocaine, lidocaine, mepivacaine, procaine, ropivacaine) via elastomeric infusion devices; some of these patients were otherwise healthy young adults. Affected patients received these agents (with and without epinephrine) for extended periods of time (eg, 48-72 hours) to control postsurgical pain, mainly following shoulder surgery. The onset of symptoms of chondrolysis occurred as early as 2 months following treatment (median: 5 months); symptoms included joint pain, stiffness, and loss of motion. More than half of these patients required repeat surgery (eg, arthroscopy, arthroplasty) as a result of the chondrolysis.

The mechanism by which the intra-articular infusion of local anesthetics results in chondrolysis has not been identified; possible factors may include the drug, elastomeric infusion device, and/or other unknown factors. Clinicians should note that single intra-articular injections of local anesthetics have been used safely during orthopedic procedures for years without resulting in chondrolysis.

Healthcare professionals are reminded that the intra-articular administration of local anesthetics is not an FDA-approved route of administration. In addition, no infusion device, including elastomeric infusion devices, are FDA-approved for continuous intra-articular infusions. The FDA has encouraged clinicians to consult and follow the approved drug and device labeling recommendations with regard to proper administration.

In the event that a patient receives a continuous intra-articular infusion of local anesthetic, the patient should be monitored for the development of chondrolysis; symptoms may take months to develop.

Further information may be found at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPati...

U.S. Brand Names

• Akten™
• Anestacon® [DSC]
• Anestafoam™ [OTC]
• Band-Aid® Hurt-Free™ Antiseptic Wash [OTC]
• Burn Jel® Plus [OTC]
• Burn Jel® [OTC]
• Burn-O-Jel [OTC]
• L-M-X® 4 [OTC]
• L-M-X® 5 [OTC]
• LidaMantle®
• Lidoderm®
• LTA® 360
• Premjact® [OTC]
• Regenecare®
• Regenecare® HA [OTC]
• Solarcaine® Aloe Extra Burn Relief [OTC] [DSC]
• Solarcaine® cool aloe Burn Relief [OTC]
• Topicaine® [OTC]
• Unburn®
• Xylocaine®
• Xylocaine® Dental
• Xylocaine® MPF
• Xylocaine® Viscous [DSC]

Medication Safety Issues

High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication (epidural administration; I.V. formulation) among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

Transdermal patch may contain conducting metal (eg, aluminum); remove patch prior to MRI.

International issues:

• Lidpen® may be confused with Linoten® which is a brand name for pamidronate in Spain

Generic Available

Yes: Infusion, injection, jelly, ointment, solution

Pharmacologic Categories

• Analgesic, Topical
• Antiarrhythmic Agent, Class Ib
• Local Anesthetic
• Local Anesthetic, Ophthalmic

Related Terms

• Lidocaine Hydrochloride
• Lignocaine Hydrochloride