The U.S. Food and Drug Administration (FDA) has announced major changes to the safety labeling of opioid pain medications to better inform patients and health care providers about the risks of these drugs.
Key Labeling Updates:
- –Clearer Risk Information: Labels will now highlight the potential for addiction, misuse, overdose, and death.
–Dosing Guidance: Warnings emphasize that higher doses and longer use increase risks. - –Defined Use Limits: Wording that suggests opioids are appropriate for indefinite use has been removed.
- –Discontinuation Guidance: Labels now caution against suddenly stopping opioids in patients who are physically dependent.
- –Overdose Prevention: New information is included about the use of naloxone, an opioid overdose reversal medication.
- –Drug Interactions: Stronger warnings are added about combining opioids with other central nervous system depressants, including gabapentinoids.
Why This Matters
These changes are designed to help patients, families, and prescribers make better-informed decisions and to improve safe use of opioid pain medications.
In addition to understanding the risks, families can take steps to protect loved ones by safely storing all medications. Proper storage helps prevent misuse, protects children and teens, and keeps dangerous drugs out of the wrong hands.
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