The Food and Drug Administration (“FDA”) has new labeling requirements for extended-release and long-acting (“ER/LA”) opioid pain relievers to ensure their safe and appropriate use.  According to the article, “the new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications.  They are also meant to reduce problems associated with their use.”

What are Opioids?

Opioids are a type of narcotic pain medication typically prescribed for relief of moderate to severe pain.  They work by changing the way the brain perceives pain.  They are available by prescription as pills, liquids and skin patches.  Extended-release and long-acting opioids may contain higher doses and their effects last for a longer period of time.  Oxycodone, Morphine and Fentanyl are examples of ER/LA opioids.  The misuse and abuse of these drugs have resulted in serious public health problems of addiction, overdose and death.

Summary of Label Changes:

Current labeling indicates that ER/LA opioids are for “the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.”  The new label will emphasize that other, less potentially addictive, treatment options should be considered first.  The new label required by the FDA says that the drugs are “indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.”  The new label will also indicate that the drugs are not intended for use as an “as needed” pain reliever.

The new label also indicates that “because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve [Tradename] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would otherwise be inadequate to provide sufficient management of pain.”

Post Market Studies and Education to Reduce Risk:

In addition to the label changes, the FDA is requiring drug companies to conduct longer term studies and trials of ER/LA opioids currently on the market.  The educational materials for patients and healthcare providers will be modified to reflect the new label changes in hopes that better education will improve the safe and appropriate use of ER/LA opioids.

See the FDA article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm367660.htm