April 11, 2019

FDA to require label changes on how to safely decrease opioids in physically dependent patients

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration (FDA) on April 9 issued a Drug Safety Announcement saying it has received reports of serious harm in patients who are physically dependent on opioid pain medications and suddenly have them discontinued or rapidly decreased.

Because of these reports, the FDA is requiring changes to prescribing information, which will provide expanded guidance on how to safely decrease the dose in patients when the dose is to be decreased or the medication is to be discontinued.

 

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