FDA requires label changes for opioid analgesics to guide prescribers when gradual tapering is needed

This is a crosspost from the Optum Insights blog.

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The U.S. Food and Drug Administration (FDA) issued a safety communication in early April that requires changes to prescribing information for opioid analgesics used in outpatient settings. The goal is to expand the information available to health care providers and patients when opioid analgesics have been prescribed and there is a need to safely decrease the dose or discontinue use of an opioid analgesic.

Decreasing or discontinuing requires individualization

Many treatment guidelines, including the Official Disability Guidelines and the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain, recommend to gradually reduce the dose of an opioid analgesic over time and monitor for signs of withdrawal when treatment is no longer necessary. However, in practice, the same tapering schedule cannot be used for everyone. The approach taken must be individualized for each person and depends on the length of therapy, dose of the medication, age of the individual, concurrent use of other medications, as well as the individual’s clinical condition.

Opioid usage and impact on workers’ comp

Opioid analgesics are commonly used to treat acute and chronic pain. Some examples of opioid analgesics include morphine, hydrocodone, hydromorphone, oxycodone and fentanyl. While these medications are commonly prescribed to treat pain associated with a number of injuries, withdrawal symptoms and serious harm to claimants can occur if opioid analgesics are suddenly discontinued or the dose is rapidly decreased without proper tapering.

Claims professionals should be aware that reducing doses, especially high morphine equivalent doses, and/or tapering off opioid analgesics should be tailored for each claimant. In some cases, this process may take months and require use of other medications to treat side effects and withdrawal symptoms.

For more information from the FDA, please click here.

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  1. U.S. Food and Drug Administration. FDA Statement. Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids. April 9, 2019. Available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635640.htm Accessed April 9, 2019.
  2. U.S. Food and Drug Administration. FDA Safety Announcement. FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 9, 2019. Available at https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm. April 9, 2019.
  3. Official Disability Guidelines (ODG), 24th edition. ODG Treatment in Workers’ Comp, Pain Chapter, 17th edition. Work Loss Data Institute. “The Evidence-Based Guideline Company”
  4. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain-United States, 2016. MMWR Recomm Rep 2016;65:1-49.