USA – FDA to require new safety warnings for opioids

The US Food and Drug Administration (FDA) last week announced new labeling updates and safety warnings for immediate-release (IR) and extended-released/long acting (ER/LA) opioids stemming from reports about patients’ increased sensitivity to pain or greater pain with use of these medications.

The reports indicated that a new warning was needed for opioid-induced hyperalgesia (OIH), which is when an opioid that is prescribed for pain causes an increase in pain, called hyperalgesia, or an increased sensitivity to pain, called allodynia.

“Extended-release/long-acting (ER/LA) opioid pain medicines have unique risks and should be used only for those with severe and persistent pain,” FDA announced…