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News

US FDA rules on Medtronic intrathecal therapy letter

Medtronic : 20 March, 2008  (New Product)
The US Food and Drug Administration (FDA) has classified Medtronic’s communication to physicians related to inflammatory mass formation associated with intrathecal drug delivery as a Class I Recall.
On January 16, 2008, Medtronic sent a letter to inform clinicians worldwide of an increase in the rate of reported inflammatory mass cases in patients who have received intrathecal Drug delivery through its implantable infusion systems. The letter was an update to two previous communications on the topic that Medtronic issued in 2001 and 2003. The classification from the FDA does not change the recommendations made to physicians in the January 2008 letter and there is no new action required of physicians or patients.

Inflammatory masses have been reported in patients who receive intrathecal therapy through the SynchroMed and IsoMed infusion systems. Inflammatory mass is a chronic inflammatory or granulomatous mass at or near the tip of intrathecal catheters and has been reported with the infusion of morphine, baclofen and other physician-prescribed drugs and/or mixtures, including pharmacy-compounded drugs.

Medtronic has noted an increase in reported cases of inflammatory mass associated with intrathecal Drug delivery from 0.1 percent reported to date in 2001 to 0.5 percent reported to date in 2007. The actual incidence is likely to be higher than stated due to under-reporting, but the extent of under-reporting is currently unknown. To date, there have been no reported deaths associated with this issue.

The most frequently reported symptoms of inflammatory mass are decreased therapeutic response, pain, and neurological deficit/dysfunction. Serious reported symptoms include paralysis and other neurological impairments.

Inflammatory mass has been associated with a wide range of doses and concentrations of opioids. No dose and/or concentration of morphine sulphate can be considered free of risk from inflammatory mass. The risk of inflammatory mass occurrence appears to increase over time and with higher concentrations of opioids. Therefore, intrathecal opioids should be administered at the lowest effective dose and concentration.

Medtronic’s January 2008 physician letter provided physicians with specific patient management recommendations that include utilizing the lowest effective dose and concentration of opioids and patient monitoring for early clinical symptoms of inflammatory mass. The letter also recommends diagnostic steps for physicians to consider for patients who have new neurological symptoms aimed at preventing more severe outcomes.
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