FDA: Unapproved Drugs Add to Intrathecal Pump Risk

Intrathecal pumps, drug-delivery systems that have been controversial in workers’ compensation, are the subject of a warning issued Thursday by the U.S. Food and Drug Administration. The FDA has cautioned against using the pumps to deliver drugs that aren’t approved specifically for use with the systems. Intrathecal pumps are surgically implanted devices, often intended for pain relief, that administer drugs directly into a patient’s spinal canal. “Pain medicines approved by FDA for delivery into the spinal fluid must meet additional safety standards because the ...