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# FDA Changing Opioid Labeling on Tapering Off Drugs
- URL: https://www.fdaweb.com/fda-changing-opioid-labeling-on-tapering-off-drugs/
- Published: 2019-04-09T12:00:00.000Z
- Updated: 2026-09-15T01:19:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143826

An FDA drug safety communication says the agency has received reports of serious harm in patients who are physically dependent on opioid medicines suddenly having the medicines discontinued or the dose rapidly decreased. Examples of the harm include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide, the communication [says](https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm?ref=fdaweb.com).

In an effort to address the issue, the agency says it is requiring changes to the prescribing information for drugs intended for outpatient use to expand guidance to healthcare professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued.

In a [statement](https://www.prnewswire.com/news-releases/statement-by-douglas-throckmorton-md-deputy-center-director-for-regulatory-programs-in-fdas-center-for-drug-evaluation-and-research-on-new-opioid-analgesic-labeling-changes-to-give-providers-better-information-for-how-to-pro-300828292.html?ref=fdaweb.com), CDER deputy director for regulatory programs **Douglas Throckmorton** says FDA also will engage with physician groups to go through the updates, so they can provide the information to their members. “When a healthcare provider and patient agree to taper the opioid,” Throckmorton says, “a variety of factors should be considered including: the dose of the drug, duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. These labeling changes also emphasize the importance of having informed discussions between patient and clinician and ensuring follow-up and support for patients managing pain and changes to their medication regimens.”