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On December 13, 2016, the FDA published the final guidance for industry describing Grading and Labeling of Abuse-Deterrent Drug Products containing opioid drugs. The guidance includes the steps and considerations needed to establish a labeling program for opioid drugs that are marketed in combination with an opioid analgesic product and that contain an opioid.
December: On December 4, FDA issued a final rule to further strengthen the risk management framework for unintentional pediatric opioid toxicity. The final rule details a comprehensive approach to monitor and manage unintentional opioid toxicity in pediatric patients who are known to have suffered from a life-threatening overdose or other serious events. The final rule also includes special requirements for product labeling for opioid pain relievers that are intended for use in the management of acute pain outside of a hospital setting.
October: On October 24, FDA approved new labeling for Vidaza (pegademase bovine), an enzyme replacement therapy for the treatment of severe combined immunodeficiency (SCID) caused by adenosine deaminase (ADA) deficiency in children. Vidaza was approved in April 2007. The most significant changes were to update the list of serious adverse events to include that Vidaza can cause reactivation of human immunodeficiency virus type 1 (HIV-1).
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On September 18, FDA announced that it is finalizing labeling for extended-release and long-acting (ER/LA) opioid analgesics. As part of the final rule, FDA is requiring an additional medication guide to be included with every prescription and to be part of the package insert for patients taking long-term opioid therapy. The guide will include information about opioid addiction and misuse, when to consider referral for and to receive treatment, when to take the medication as prescribed, when to consider switching medications, and how to identify and report a medication error.
On September 19, FDA announced the agency is amending the drug product labeling of Neurontin (gabapentin) to include warnings and precautions based on the latest clinical data and information that highlights the risks of potential interactions when it is used with other agents, including opioid analgesics.
October: On October 1, FDA announced the agency plans to require a new patient label on opioid analgesics that will provide prescribers and their patients with more information and help them safely use the medications.The label will direct prescribers to more comprehensive information on the use of opioids for pain, including information on risks of misuse and abuse and ways to manage the risk of misuse and abuse of opioid pain relievers.
June: On June 6, FDA issued guidance to the drug manufacturers to label all brands of buprenorphine-naloxone products to include information and warnings about the use of opioid agonist medications in combination with naloxone, which can increase the risk of opioid overdose. This guidance was issued in response to patient request for additional information about risk of overdose. The guidance includes:
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