The US Food and Drug Administration (FDA) is alerting healthcare providers about the risk for complications with intrathecal administration of pain medications that are not approved for use with implanted intrathecal pumps.
These complications may include dosing errors, pump failure, opioid withdrawal, and infection, as well as pain, fever, vomiting, muscle spasms, cognitive changes, weakness, and cardiac or respiratory distress.
"The treatment of pain has become increasingly complex," FDA Commissioner Scott Gottlieb, MD, said in a news release.
Implanted pumps that deliver medication directly into the spinal fluid can play an important role in treating pain, but 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 Gottlieb.
In a safety communication, the FDA reminds providers that the only approved medicines identified in FDA-approved implanted pump labeling for intrathecal infusion to treat or manage pain are morphine sulfate preservative-free injectable solution (Infumorph, West-Ward Pharmaceuticals) and preservative-free ziconotide sterile solution (Prialt, TerSera Therapeutics).
The FDA advises providers to review current labeling (ie, instructions for use) of the implanted pump, because not all pumps are currently approved for use with Prialt.
In reviewing medical device reports and other information, the FDA discovered that patients are sometimes treated with medications that are not approved for use with an intrathecal implanted pump. Such drugs include compounded medicines, hydromorphone, bupivacaine, fentanyl, and clonidine.
Any mixture of two or more different kinds of medicines and any compounded medicine (eg, to achieve higher concentration or different formulation of an FDA-approved medicine) are not approved for use, the FDA said.
Using drugs not approved for use with these pumps "may lead to serious risks to patients due to pump failure or dosage errors," the FDA said.
The FDA has determined that implantable intrathecal pump failure is more common with the use of medicines not approved for use with the pump. Some medicines or fluids may contain preservatives or other characteristics that can damage the pump tubing or lead to corrosion of the pumping mechanism, it points out.
Dosing errors are also a risk with unapproved medicines. Programmable implanted pumps employ dose calculation software, and the accuracy of calculations depends on use of the approved medicine, approved medicine concentration, and approved medicine characteristics. A problem may arise, for example, if there is more than one medicine in the pump reservoir. In such cases, the pump software can calculate the dose only on the basis of the infusion rate of a single medicine, the FDA said.
Healthcare providers are encouraged to report problems with implanted pumps to the FDA's MedWatch Adverse Event Reporting Program.
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Cite this: FDA Warns Against Using Unapproved Meds in Implanted Pain Pumps - Medscape - Nov 14, 2018.
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