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FDA Alert: Implanted Pumps: Safety Communication

FDA Alert: Implanted Pumps: Safety Communication

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November 14, 2018

[Posted 11/14/2018]

AUDIENCE: Patient, Caregiver, Health Professional, Pain Management, Pharmacy, Neurology, Surgery

ISSUE: The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the 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.

BACKGROUND: Implanted pumps are medical devices that are surgically implanted under the skin, typically in the abdomen. They are connected to an implanted catheter and are used to deliver prescription medicines and fluids within the body, including the intrathecal space (into the spinal fluid), to treat pain, muscle spasticity, and other diseases or conditions. Implanted pumps are periodically refilled with medicines or fluids by a health care provider.

They are often used to treat or manage pain after other treatments, such as oral medicines, physical therapy, or surgery, are unsuccessful.

The FDA-approved implanted pump labeling identifies which pain medicines are approved for use with each pump. Pain medicines approved by FDA for delivery into the spinal fluid must meet additional safety standards because the spinal cord and brain tissue are highly sensitive to preservatives or infectious organisms such as bacteria or viruses. The implanted pump’s current labeling should be reviewed to determine which pain medicines are approved for use in each pump. The table below includes examples of medicines approved and not approved for intrathecal use with implanted pumps to treat or manage pain.

RECOMMENDATION: When considering a medicine for use in an implanted pump:

  1. Review the implanted pump labeling to identify the medicines and medicine concentrations approved for use with that specific pump.

  2. 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)

  3. 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.

  4. 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.

  5. Report adverse events to the FDA if you suspect an implanted pump is having problems:

    • User facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

    • Health care providers employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

  • Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/14/2018 – Medical Device Safety Communication – FDA]

 

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