The Food and Drug Administration yesterday warned the health care community about complications that arise when pairing pain medications with intrathecal implanted pumps when the medications are not approved for use with those devices, which deliver medicine into spinal fluid. Clinicians may have chosen these alternatives – such as hydromorphone, bupivacaine, fentanyl and clonidine – to avoid the side effects of approved drugs, or because they may appear to be more effective at relieving pain, the FDA said. However, such substitutions might not meet the additional safety standards required of approved drugs, and as such, can cause dosing errors, pump failure, opioid withdrawal and infection, the agency said.
“We urge health care providers, patients and caregivers to be aware of the information the FDA is providing today so they can make informed treatment decisions,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA will continue to monitor the safety of these and other medical devices involved in the treatment of pain, and take action where needed to protect patients.”