FDA Issues Safety Warning On Use Of Unapproved Pain Meds With Implanted Drug Pumps

Federal health officials are warning patients and healthcare professionals that only certain pain medications are approved for use with implantable pumps that delivery pain management therapy, indicating that unapproved drugs could result in serious and potentially fatal adverse health consequences.

The U.S. Food and Drug Administration (FDA) issued an implantable drug pump warning on November 14, noting that patients are commonly given pain medicines in the spinal fluid that have not been approved by federal regulators, increasing the risk of dosing errors, pump failures, and other health risks.

Implantable drug pumps are medical devices that are surgically implanted under a patient’s skin and connected to an implanted catheter to deliver prescription medicine and fluids throughout specific parts of the body to treat pain, muscle spasms, and a variety of diseases and conditions. The implanted pumps are often used after oral medications, physical therapy or surgery are unsuccessful.

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Drug delivery pumps are approved by the FDA, but only certain medications have been deemed safe and effective to use. When delivering pain management medications to the spinal area in patients, the prescription medication must meet additional safety standards to protect the spinal cord and brain tissue. These areas of administration are highly sensitive to preservatives and infectious organisms and must be thoroughly tested and approved before use, according to FDA officials.

The FDA has received reports of physicians using the drug pumps to deliver pain medication to patient’s spinal regions that are not listed on the pump’s current labeling.

The warning details patients be given unapproved medications are at risk of are dosing errors, pump failures, patient opioid withdraw, infection among various other complications such as fever, vomiting, muscle spasms, cognitive changes, weakness and cardiac or respiratory distress.

Programmable implanted pumps administer the doses of medication based on a software that calculates the correct dosage for each patient. The accuracy of the software is based on using preselected medications that are similar in characteristics and concentration. This may cause unapproved prescription medications to be dosed in inaccurate portions and increase a risk to patients.

In addition to patient injuries, the physical machines could be susceptible to failure when using medications not approved. The FDA has determined administration of spinal fluid medications were associated with a higher failure rate. Officials reported certain fluids’ characteristics such as preservatives can damage the pump tubing or lead to corrosion of the pump mechanisms.

These mechanical complications have been found to cause unexpected malfunctions such as motor stalls which stop drug therapy treatment abruptly. This could result in medication withdrawal and require immediate surgery to remove or replace the pump.

FDA officials are warning physicians to review the implanted pump labeling to identify the approved medications and concentrations before planning therapeutic treatments. Adverse events should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting program.


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