FDA to Change Opioid Labeling Rules to Emphasize Long-Term Risks

FDA updates labeling requirements for opioid pain medications

Washington, D.C. — The FDA has announced new safety labeling requirements for all opioid pain medications within the U.S. The new labeling will provide emphasis on the risks associated with long-term opioid drug use.

FDA to change opioid labeling rules to emphasize long-term risks

(The Center Square) – The U.S. Food and Drug Administration plans to require new labels on all opioid pain medications that emphasizes long-term risks associated with the use of the drugs.

FDA orders changes to opioid safety labels

The U.S. FDA is requiring changes to safety labels for all opioid medications, explaining risks associated with their long-term use, according to a press release from HHS. These risks include misuse, addiction, nonfatal overdoses and fatal overdoses, based on data presented during a public advisory committee meeting in May.

FDA Changes Opioid Pain Medication Labeling Requirements

The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.

FDA to stress opioids’ risk of overdose, death in new medication safety labels

The decision comes nearly 30 years after initial approval of OxyContin, the now-infamous painkiller sold by Purdue Pharma.

FDA Mandates Major Labeling Changes on Opioid Pain Medication

The Food and Drug Administration is requiring pharma companies selling opioid pain medications to “better emphasize and explain the risks associated with their long-term use” on medication labels, the Department of Health and Human Services (HHS) said in a July 31 statement. “These changes follow a public advisory committee meeting in May that reviewed data showing serious risks—such as misuse, addiction, and both fatal and non-fatal overdoses—f…