“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” said Robert Califf, MD, FDA commissioner.
In 2013, the FDA required labeling changes for extended-release/long-acting opioids, and Tuesday’s announcement now requires similar boxed warnings on immediate release opioids. Labels on IR opioid medications will now be required to include a boxed warning cautioning patients about the risks of misuse, abuse, addiction, overdose and death. The labels will also include new dosing information with clearer guidelines regarding patient monitoring and drug administration, including a warning against sudden treatment stoppage in patients physically dependent on the medication.
Additionally, the FDA is now requiring labels on all opioids to include information on potentially harmful drug interactions and opioids’ effect on the endocrine system.
“The broad set of actions announced today is reflective of the FDA’s efforts to improve informed prescribing of opioids across the board,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “We have been and will continue to evaluate all new data to ensure that labels of opioid drugs contain appropriate prescribing information about the benefits and risks of prescription opioids.”
More articles on opioid use:
A third of Americans say physicians are to blame for opioid crisis, survey suggests
New poll shows public’s complicated feelings about opioid use: 4 important takeaways
Senate passes bill to fight drug addiction: 5 things to know
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