Officials with the FDA noted that patients are sometimes being treated with medications that are not approved (including compounded medicines as well as hydromorphone, bupivacaine, fentanyl and clonidine) for use with an intrathecal implanted pump.
Officials with the US FDA have alerted health care providers and patients about the serious complications, including dosing errors, pump failure, withdrawl, and other issues that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain.
Currently, the FDA-approved implanted pump labeling identifies pain medicines that have been evaluated by the FDA for compatibility with the pump, including Infumorph and Prialt. However, not all pumps are currently approved for use with Prialt. Drugs approved for intrathecal administration must meet additional safety standards over those administered in other ways because the spinal cord and brain tissue are highly sensitive to preservatives or infectious organisms such as bacteria or viruses, which can lead to serious complications, according to a statement from the FDA.
Officials with the FDA noted that patients are sometimes being treated with medications that are not approved (including compounded medicines as well as hydromorphone, bupivacaine, fentanyl and clonidine) for use with an intrathecal implanted pump. The reasons sometimes cited for the use of drugs not approved for use with implanted pumps have included that approved medications listed in the pump labeling may have undesirable side effects or may fail to deliver adequate pain relief for some patients. The FDA is alerting providers that using drugs not approved for use with these pumps may lead to serious risks to patients due to pump failure or dosage errors.
FDA officials recommend that health care providers review the implanted pump labeling to identify the medicines and medicine concentrations approved for use with the specific pump.
The FDA issued this safety communication after reviewing medical device reports, premarket device applications, mandated FDA post approval studies, publicly available scientific literature, current device labeling, and information from health care providers and device manufacturers.
Patients and providers who experience an adverse event due to an implanted pump or suspect an infusion pump is having problems, are encouraged to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.