New Warning Labels for Opioid Pain Medications

Opioid pain medications can be dangerous if taken improperly and also have the potential for dependence. Despite warning labels on medication bottles, people often fail to heed the warnings. In an attempt to make it more clear, the U.S. Food and Drug Administration (FDA) has announced changes to the safety labels on extended-release and long-acting opioid painkillers.

The FDA will call attention to the dangers of abuse and possible death, Reuters reports. Other warnings will be the risks to babies whose mothers take the medicines. 

The labels will appear on the drugs:

• OxyContin
• Fentanyl
• Morphine

Labels will now indicate that the drugs should be used only by patients in pain that is severe enough to require daily, constant, long-term opioid treatment. That is those patients who have not had adequate pain relief from other medicines.

“The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities,” FDA Commissioner Margaret Hamburg said in a news release.

The FDA will require additional studies of opioid pain medication to assess risks of abuse, overdose, and death.

Related articles

• FDA orders starker warnings on opioid painkillers (seattletimes.com)
• FDA announces new labeling and safety rules for opioids (medicalnewstoday.com)