Safety Communication from the U.S. Food & Drug Administration
Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication
Warning-this is a comprehensive detailed safety communication-if this information pertains to you-it is recommended that FDA COMMUNICATION IS REVIEWED IN DETAIL at the FDA website
Device:
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.
Summary of Problem and Scope:
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.
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.
FDA Analysis
The FDA has received numerous Medical Device Reports (MDRs) describing adverse events with implanted pumps. These reports describe pump failures, dosing errors, and other potential safety issues. Patients’ symptoms described in these reports include pain, opioid withdrawal, fever, vomiting, muscle spasm, cognitive changes, weakness, cardiac and respiratory distress. In addition to MDRs, the FDA reviewed available data from other sources including premarket device applications, mandated FDA postapproval studies, publicly available scientific literature, current device labeling, information from health care providers, and device manufacturers. Based on this analysis, the FDA is sharing information about pump failures, dosing errors, and other safety information so that patients and providers can make informed treatment decisions.
