FDA Warns Against Using Implanted Pumps With Unapproved Drugs

Regulatory NewsRegulatory News | 14 November 2018 |  By 

The US Food and Drug Administration (FDA) on Wednesday warned physicians against using implantable pumps to deliver pain medications directly into patients’ spinal fluid with drugs they were not approved for use with.
Using drugs that have not been approved for compatibility with the pumps could lead to dosing errors, pump failure, opioid withdrawal, infection, fever, vomiting, muscle spasms, cognitive changes and cardiac or respiratory distress, FDA says.
“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,” FDA Commissioner Scott Gottlieb said.
The use of implantable pumps to deliver pain medication is typically reserved for patients whose pain cannot be adequately managed through other means.
“Currently, the FDA-approved implanted pump labeling (Instructions for Use) identifies pain medicines that have been evaluated by the FDA for compatibility with the pump, including Infumorph [morphine sulfate] and Prialt [ziconotide],” FDA says, noting that not all implantable pumps are approved for use with Prialt.
FDA also says that drugs approved for injection into the spine must meet more rigorous safety standards than other drugs as the spinal cord and brain tissue are highly sensitive to preservatives and infectious organisms.
Yet FDA says it has received reports of patients being treated with drugs that have not been approved for use with implantable pumps, including compounded drugs, hydromorphone, bupivacaine, fentanyl and clonidine.
According to FDA, pump failure is more common with medicines not approved for use with the pumps, as preservatives or other components of the drugs can damage the pumps’ tubing or cause corrosion. Because the pumps are implanted, failure means that patients must undergo additional surgery to replace the pump in the event it fails.
As the pumps are only approved for use with specific medications, FDA says they are only pre-programmed with calculations for the specific medicines listed in their approved labeling and should not be used with compounded medicines or mixtures of two or more drugs.
FDA, Safety Communication


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy