FDA Warns Against Off-Label Use of Implantable Pain Pumps

FDA is cautioning doctors and patients about the serious complications that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain. Complications may include dosing errors, pump failure, opioid withdrawal, and infection, not to mention pain,  muscle spasms, cognitive changes, weakness, and cardiac or respiratory distress. “The treatment of pain has become increasingly complex. While medical devices, such as implanted pumps that deliver medication directly into the spinal fluid, have the potential to play an important role in treating pain, their use must be judicious and their instructions for use must be carefully followed. This is especially true when it comes to implantable pumps that deliver analgesic medicine directly into the nervous system,” said FDA Commissioner Scott Gottlieb, MD. “We urge healthcare providers, patients and caregivers to be aware of the information the FDA is providing today so they can make informed treatment decisions." Gottlieb said the agency 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. Implanted pumps require a health care provider to periodically refill the pump with medication. Intrathecal delivery of medication with an implanted pump for pain management is ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Implants Source Type: news