FDA mandates new labeling for all opioid medications

Opioid medications will now be required to have updated warning labels and safety information, according to a new mandate from the FDA.

The requirements also extend to medication guides to provide further information on the dangers of opioid pain medications for patients and caregivers. The efforts are part of the agency's ongoing work to combat the opioid crisis nationwide and further educate the public on preventing addiction and death. The updates are also aimed at providers to guide them in appropriate opioid pain medication prescribing practices.

"These changes to the prescribing information are designed to inform about appropriate prescribing of opioid pain medicines while also recognizing that they remain an important treatment option in appropriate situations and that undertreatment of pain  … carries its own risks, including other morbidities and even the risk of illicit substance use for self-treatment," the agency states in an updated FAQ on the new requirements.

The FDA also published examples of the label changes, which will now include:

  • Stating that the risk of opioid overdose increases as dosage increases.
  • Stating use for extended periods of time should be avoided as much as possible.
  • Noting that extended release/long acting opioids be reserved and only prescribed when alternative options are not adequate to treat pain.
  • Adding a warning to both immediate and extended release medications about opioid-induced hyperalgesia, a condition that increases sensitivity to pain making it more severe. 
  • Adding a warning about the risk for life-threatening respiratory depression.
  • Adding a warning about the dangers of using the medication in conjunction with benzodiazepines and other medications that may depress the nervous system. 

The updated requirements apply to both immediate and extended-release opioid medications. The FDA recommends healthcare providers continue to educate patients about the risks, encourage them to read all medication guides and labels thoroughly and continuously reassess the need for opioid prescription and use to reduce risks for addiction.

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