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Medical Devices / Postmarket Safety

FDA Issues Alert Over Misuse of Implantable Pumps

Nov. 21, 2018
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The FDA issued an alert on the possibility of implantable pump failure or dosage errors from using pain medications not approved for use with pumps that deliver drugs into the spinal fluid.

FDA-approved Instructions for Use for implantable pumps list pain medicines that have been evaluated by the agency for compatibility with the pump, including Infumorph and Prialt. But not all pumps are approved for use with Prialt. 

The agency has learned that patients are sometimes being treated with medications that are not approved for use with an intrathecal implanted pump.

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