FDA warns against joint infusions for post-op pain.
Cases of chondrolysis diagnosed in people a median of 8.5 months after they received a continuous intra-articular infusion of a local anesthetic for postsurgical pain with an infusion pump have prompted the Food and Drug Administration to issue a statement recommending against this practice.
"Because the reported cases involved significant injury to otherwise healthy young adults, the FDA wants to advise health care professionals that elastomeric infusion devices or any other infusion pump are not cleared by [the agency] to deliver intra-articular infusions of local anesthetics and should not be used for this purpose," according to the statement, which listed bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, and ropivacaine as the marketed local anesthetics.
The statement also pointed out that local anesthetics are approved as injections "for the production of local or regional anesthesia or analgesia" and are not approved for continuous intra-articular postoperative infusions.
"It is important to note that single intra-articular injections of local anesthetics in orthopedic procedures have been used for many years" without any reports of chondrolysis, the statement added.
The 35 reports of chondrolysis were reviewed by the FDA were reported between 2006 and 2008 in people aged 16 to 58 years (median 25 years), mostly after shoulder surgery; 6 were in people between aged 16 to 18.
Symptoms of chondrolysis were reported as early as the second month after the infusion and in more than half of the cases, additional surgery was needed, according to the FDA.
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|Comment:||FDA warns against joint infusions for post-op pain.(NEWS)|
|Publication:||Family Practice News|
|Article Type:||Brief article|
|Date:||Dec 1, 2009|
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