FDA updates opioid prescribing information

Editor's Note

The Food and Drug Administration (FDA), on April 13, updated prescribing information for all opioid pain medications, including requiring all packaging to have updated labeling and safety information.

This includes stating that:

• for both immediate-release (IR) and extended release/long acting (ER/LA) opioid pain medications, the risk of overdose increases as the dose increases
• IR opioids should not be used for an extended period unless pain remains severe enough to require them and alternative treatments are inadequate
• ER/LA opioid pain medications should only be used for severe and persistent pain that requires extended treatment and alternatives are inadequate
• both IR and ER/LA opioids come with the risk of opioid-induced hyperalgesia and life-threatening respiratory depression
• there are risks associated with using opioids in conjunction with benzodiazepines.

The FDA notes that: “These changes are designed to provide essential information that prescribers need to prescribe opioid pain medicines appropriately, but the prescribing information itself cannot substitute for individual clinical judgment and talking to patients about their pain control.”