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For example, the FDA recognized that off-label uses of Transmucosal Immediate Release Fentanyl (TIRF) drugs in non-cancer pain had exceeded on-label uses, but went on to approve Subsys in 2012 because having another option that is different in formulation, in this case a sublingual spray, is helpful to patients. In contrast, payors often denied coverage for the use of TIRF medicines beyond break-through cancer pain due to the high cost of these medicines

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During the study period, a total of 7,927,000 reports were retrieved from the FAERS database

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Doctors closely monitored the patients internal organs throughout the trial to ensure safety