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FDA Warns: Use Only Approved Medications in Intrathecal Pumps

November 15, 2018
Pain medications administered via implanted pumps must be approved for this use.

A PPM Brief

In a new FDA release,1 the agency has warned healthcare providers 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.” FDA shared that complications could include: dosing errors, pump failure, opioid withdrawal, infection as well as pain, fever, vomiting, muscle spasms, cognitive changes, weakness, and cardiac or respiratory distress.

Source: 123RFMedicines used in implanted pumps must be FDA approved for such use.

Typically, intrathecal pumps are used in patients who have not found success with other pain management approaches. While these pumps play a key role in pain control, said FDA Commissioner Scott Gottlieb, MD, “their use must be judicious and their instructions for use must be carefully followed” especially when analgesics are delivered directly into the nervous system.”

To clarify the alert, the agency noted that current “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 and Prialt. However, not all pumps are currently approved for use with Prialt. Drugs approved for intrathecal administration must meet additional safety standards over those administered in other ways because the spinal cord and brain tissue are highly sensitive to preservatives or infectious organisms such as bacteria or viruses, which can lead to serious complications.”

The reason for the warning has to do with reports of patients being treated via pumps with unapproved medications, including compounded medicines, hydromorphone, bupivacaine, fentanyl, and clonidine). On occasion, unapproved medications are used to avoid side effects of approved medications or when approved medications fail to deliver adequate relief, according to the agency release. However, “the FDA is alerting providers that using drugs not approved for use with these pumps may lead to serious risks...”

For example, the agency noted that implantable intrathecal pump failure is more frequent when unapproved medicines are used as they may contain preservatives or other characteristics that can damage the pump tubing or pumping mechanism. Dosage errors may occur as well. The accuracy of programmable implanted pumps relies on software calculations that were made for use with the approved medications, including their concentration and characteristics. “For example, if there is more than one medicine in the pump reservoir, the pump software can only calculate the dose based on the infusion rate of a single medicine,” according to the release. 

Going forward, FDA recommends HCPs “review the implanted pump labeling to identify the medicines and medicine concentrations approved for use with the specific pump.” 

 

 

 

Last updated on: November 15, 2018
Continue Reading:
Guide to Implantable Devices for Intrathecal Therapy
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