The FDA today warned doctors and patients about the serious complications that can occur when using the wrong painkillers with implantable drug pumps.
Dosing errors, pump failure, and infection are just some of the potential problems that can crop up when using drugs that aren’t approved for use with particular devices, the regulatory agency said.
“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,” FDA commissioner Dr. Scott Gottlieb said in prepared remarks.
There are drugs that are specifically approved for intrathecal administration. These painkillers have to meet certain safety standards since they are targeted directly to the spinal cord and brain tissue.
The FDA said that it’s seen some cases where patients are being treated with drugs like fentanyl and clonidine with an intrathecal implanted pump.
The agency also noted that some medicines may have preservatives or features that damage the pump tubing or corrode the pumping mechanism, leading to pump failure.
The FDA recommended that healthcare providers review the pump’s labeling to verify the kinds of medicines approved for use with the pump. Patients who experience an adverse event related to an implanted pump should file a voluntary report through the FDA’s MedWatch program.
“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,” Gottlieb added. “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.”
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