FDA to Change Opioid Labeling Rules to Emphasize Long-Term Risks
UNITED STATES, JUL 31 – The FDA mandates opioid labels to highlight addiction, misuse, overdose, and other risks from long-term use based on data from two large postmarketing studies.
- The FDA revealed it is requiring safety labeling changes to opioid pain medications to emphasize long-term risks, following a review of new data and public feedback.
- Following a May advisory committee meeting and review of postmarketing requirements PMR 3033-1 and PMR 3033-2, the FDA mandated safety label updates for opioids.
- Among the required changes, prescription opioid labels will include clearer risk summaries on addiction, overdose, and misuse, with stronger warnings on higher doses and drug interactions with gabapentinoids, FDA said.
- In response, the FDA sent letters to applicants outlining labeling changes, and the impact remains unclear.
- The FDA has also required a prospective, randomized, controlled clinical trial to examine benefits and risks of long-term opioid use, though the public health impact remains unclear.
29 Articles
29 Articles
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 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…
Coverage Details
Bias Distribution
- 64% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium