The US Food and Drug Administration (FDA) has warned against the use of implantable pumps to deliver pain medications, not approved for use with the medication, directly into patients’ spinal fluid.
According to the regulatory agency, this type of use may lead to dosing errors, pump failure, opioid withdrawal, infection, muscle spasms and cognitive changes, among other complications.
The FDA warning comes after a review of medical device reports, premarket device applications, mandated post-approval studies, scientific literature, current device labelling, and information from health care providers and device manufacturers.
Implantable pumps are surgically inserted under the skin. They are connected to an implanted catheter to deliver drugs into the body for the treatment of various diseases and conditions.
Intrathecal delivery of medication using these devices for pain management is meant for patients who experience inadequate responses to other pain treatments.
Existing FDA-approved implanted pump labelling includes pain medicines assessed by the regulatory authority for compatibility with the pump.
The FDA has discovered that sometimes unapproved medications are being administered with an intrathecal implanted pump.
FDA commissioner Scott Gottlieb “While medical devices, such as implanted pumps that deliver medication directly into the spinal fluid, have the potential to play an important role in treating pain, their use must be judicious and their instructions for use must be carefully followed.
“We urge health care providers, patients and caregivers to be aware of the information the FDA is providing today so they can make informed treatment decisions.”
Intrathecal pump failure was found to be more frequently associated with the use of medicines that are not approved for use with the device, leading to the undesirable functioning of the pump.