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Abrupt Discontinuation of Opioids Dangerous, FDA Warns

Reports of “serious harm” in patients dependent on opioid painkillers who suddenly stop taking the medication, or rapidly decrease the dose, have prompted a drug safety communication issued today by the US Food and Drug Administration (FDA).

Harms from abruptly stopping opioids or rapidly decreasing the dose include “serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide,” the FDA said.

While the FDA continues to track this “safety concern,” the agency is requiring changes to the prescribing label for these medicines that are intended for use in the outpatient setting. These changes are designed to promote safe tapering or discontinuing of opioids in patients who are physically dependent on the medication.


Megan Brooks