- Using medicine in implanted pumps for intrathecal administration of pain medication that is not approved for use in the pump raises the risk for dosing errors and may more than double the likelihood for a pump failure, according to a new advisory from the FDA.
- Other complications have included opioid withdrawal and infection, as well as pain, fever, vomiting, muscle spasms, cognitive changes, weakness, and cardiac or respiratory distress.
Why this matters
- Reasons cited for using nonapproved medications include adverse effects and lack of adequate pain relief.
- Only Infumorph (morphine sulfate) and Prialt (preservative-free ziconotide sterile solution) are FDA approved in implanted pump labeling for intrathecal infusion for pain therapy.
- Medicines not approved for use with implanted pumps include:
- Hydromorphone, bupivacaine, fentanyl, clonidine, and other medicines not FDA approved for intrathecal administration or intrathecal implanted pump use.
- Any mixture of ≥2 different kinds of medicines.
- Any compounded medicine.
- Report adverse events to the FDA:
- Patients, caregivers, and physicians may file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- User facilities must comply with Medical Device Reporting regulations.
- Healthcare providers employed by facilities subject to the FDA’s user facility reporting requirements should follow their facilities’ reporting procedures.