FDA Safety Communication Urges Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management
In a new safety communication, the U.S. Food and Drug Administration (FDA) is providing recommendations and sharing important information with health care providers, pharmacists, compounders, patients and caregivers about the risks of using medications delivered into the spinal fluid to treat or manage pain that are not approved for use with implanted pumps.
The FDA is aware that patients undergoing treatment or management of pain with pain medicines via intrathecal administration that are not FDA approved for use with the patient’s implanted pump. While individual patients may experience some relief from using pain medicines not approved for intrathecal administration in their implanted pumps, such use may create additional risks including dosing errors, pump failures, and other safety concerns. The FDA wants to ensure that patients, caregivers, compounders, pharmacists, and health care providers are aware of these risks to make informed treatment decisions.
The FDA’s Safety Communication includes a table with examples of medicines approved and not approved for intrathecal use with implanted pumps to treat or manage pain as well as information about pump failures, dosing errors, and other safety information so that patients and providers can make informed treatment decisions.
When considering a medicine for use in an implanted pump the FDA offers the following recommendations:
- Review the implanted pump labeling to identify the medicines and medicine concentrations approved for use with that specific pump.
- Be aware that the following medicines are NOT currently approved for use with implanted pumps for intrathecal infusion of pain medications:
- Medicines not FDA approved for intrathecal administration or intrathecal implanted pump use (for example, hydromorphone, bupivacaine, fentanyl, clonidine)
- ANY mixture of two or more different kinds of medicines
- Any compounded medicine (for example, to achieve higher concentration or different formulation of an FDA approved medicine)
- Be aware that while individual patients may experience some relief from using medicines not approved for intrathecal administration in their implanted pumps for pain management, such use may pose additional risks including pump failures, dosing errors, and other potential safety issues.
Health care providers, patients, and caregivers are encouraged to consider and discuss both the benefits and risks of using implanted pumps for the intrathecal infusion of medications for pain management in order to make informed treatment decisions. Report adverse events to the FDA if you suspect an implanted pump is having problems.
Follow the link below to read the entire Safety Communication.
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