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FDA Advises Caution When Selecting Pain Medicine for Intrathecal Administration

Use of Non-Approved Pain Medications Could Cause Dosing Errors, Pump Failures

Patients undergoing treatment for or management of pain are often given pain medications in the spinal fluid (intrathecal administration) that are not FDA-approved for use with their implanted pump. While some patients may experience relief from such medicines, using them could cause additional risks including dosing errors, pump failures, and other safety concerns.

FDA-approved implanted pump labeling identifies which pain medicines are approved for use with each pump. Because the spinal cord and brain tissue are extremely sensitive to preservatives and bacteria or viruses, pain medicines approved by the FDA for delivery into the spinal fluid must meet additional safety criteria. It is important to review the current labeling on patients’ implanted pumps to determine which pain medicines should be administered.

Medications that are not currently approved for use with implanted pumps for intrathecal infusion of pain medications include hydromorphone, bupivacaine, fentanyl, and clonidine; any mixture of two or more different kinds of medicine; and any compounded medicine.

Source: Drugs.com, November 19, 2018.

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