After reviewing some myriad reports detailing the chondrolysis (loss of cartilage) from patients following routine arthroscopic shoulder surgery, the FDA is now mandating that the manufacturers of local anesthetics (for example, bupivacaine, chloroprocaine, lidocaine, mepivacaine, procaine, and ropivacaine) place specific warnings on their drugs.
The FDA’s notice to healthcare providers states:
The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics.
Specifically, healthcare providers are warned against using these drugs in pain pumps for continuous intra-articular infusion of local anesthetics after orthopedic surgery. The warning is not limited to shoulder surgery.
The requirement that drug manufacturers place appropriate warnings on their drugs is a significant step forward and bolsters the position of plaintiffs in pain pump cases around the country. In many of those cases, the pain pump manufacturers and the manufacturers of the anesthetic drugs have been sued. The anesthetic manufacturers are disclaiming liability, saying that they have no responsibility for how their drugs are used. Clearly, the FDA thinks otherwise.