The U.S. Food and Drug Administration (FDA) convened a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to review two postmarketing studies (PMR 3033-1 and 3033-2) examining the risks of misuse, addiction, and fatal and non-fatal overdose among patients receiving long-term opioid therapy. These studies generated new quantitative evidence on these risks. Based on the findings, along with input from the committees, public comments, and existing literature, the FDA determined that updated safety information should be added to opioid drug labeling to better inform patients and providers about the benefit-risk profile of long-term use and support more informed treatment decisions.
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