Nearly half of the patients prescribed high potent transmucosal immediate-release fentanyl (TIRF) reserved to treat breakthrough pain in cancer patients already on round-the-clock opioid therapy, were given the drugs off-label. Yet, when this evidence surfaced, the Food and Drug Administration (FDA) dragged its feet on addressing the problem. And when it did, the agency only made a “few substantive changes” to its Risk Evaluation Mitigation Strategy (REMS), according to a study published in JAMA. The REMS for TIRF drugs was approved by the FDA on Dec. 28, 2011, because the medications were very potent and there was a high risk ... Read More
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