Physician Response to Medtronic's Position on the Use of Off‐label Medications in the Synchromed Pump

In November of 2012, Medtronic sent an Urgent Medical Device Safety Notification to physicians who implant Medtronic Synchromed intrathecal infusion pumps warning them not to use unapproved (off-label) medications in the SynchroMed pump. In this communication, Medtronic stated, “The use of unapproved drugs can lead to intermittent or permanent pump motor stalls which may be reported as a loss of or change in therapy. Therapy changes could potentially result in serious injury and/or death.”This strongly-worded Medtronic Safety Notification has caused great consternation among implanting physicians because off-label (and hence unapproved) medications are commonly used in SynchroMed pumps and the majority of chronic pain patients require the use of these off-label medications to achieve adequate pain relief or to control unacceptable drug induced side effects. As national and international societies representing thousands of physicians who manage chronic pain patients with intrathecal drug delivery (IDD) using the Medtronic SynchroMed pump and catheter system, we are compelled to respond to Medtronic’s stated position regarding the use of off-label medications in the SynchroMed pump. Today the vast majority of patients receiving continuous long-term intrathecal therapy for pain are receiving compounded admixtures of medications, defining this as the current standard of care. The need for this clinical approach of using compounded medication admixtures for IDD relates to the lack of commercially available preparations to replace the multitude of medication combinations commonly used by expert implanters. It is important to note that pump failure can occur for a variety of reasons and therefore vigilance on both the physician and patient’s part are important whether onor off-label medications are utilized.