The Food and Drug Administration (FDA) has issued a safety communication regarding the risks associated with implanted pumps for intrathecal administration of pain medications.
Reports of pump failure, dosing errors, as well as other possible safety issues have prompted the Agency to issue an alert to make prescribers aware of the dangers associated with using medications not specifically approved for intrathecal administration with the implantable pump. Examples of drugs not identified in implantable pump labeling include hydromorphone, bupivacaine, fentanyl, clonidine, as well as any mixture of 2 or more different drugs; compounded medicines are also not included in the current labeling for implanted pumps.
Medicines that have approved indications for use with implanted pumps include Infumorph (morphine sulfate; preservative-free injectable solution) and Prialt (ziconotide preservative-free sterile solution); labeling instructions for the implanted pump should be reviewed prior to administration as not all pumps are currently approved for use with Prialt.
Using medications that are not identified in implanted pump labeling for intrathecal infusion could potentially lead to serious adverse events. These include pump failures, dosing errors, and other safety issues such as infection and granuloma formation.
Recognizing the risks involved with using pain medications delivered into the spinal fluid, the FDA has issued the following recommendations:
- Implanted pump labeling should be reviewed to identify drugs and concentrations approved for use with the specific pump
- Be aware of medicines that are not FDA-approved for use with implanted pumps for intrathecal infusion
- The benefits and risks associated with implanted pump use for intrathecal administration of pain medications should be discussed with patients and caregivers in order to help make informed treatment decisions
- Adverse events related to implanted pumps should be reported to MedWatch
In a press statement, the FDA acknowledged that some patients may not be adequately managed with the medications currently approved for use with these pumps, however, according to the Agency, use of unapproved pain medications carries several risks including possible opioid withdrawal symptoms or overdose.
“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. This is especially true when it comes to implantable pumps that deliver analgesic medicine directly into the nervous system,” said FDA Commissioner Scott Gottlieb, MD. “We urge healthcare providers, patients and caregivers to be aware of the information the FDA is providing today so they can make informed treatment decisions.”
For more information visit FDA.gov.