Near the end of 2013 the U.S. Food and Drug Administration (FDA) made some changes to opioid labeling. Specifically, the agency has modified the safety labeling on extended release and long acting medications that fall under the category of opioids. This comes after an organization called PROP (Physicians for Responsible Opioid Prescribing) petitioned the FDA to make some of these major changes in an effort to limit the prescription and use of these medications because of long-standing safety concerns.
The FDA shares these concerns about the overuse and abuse of opioid medications but wants to ensure that patients who require them for treatment still have safe access. The new opioid labels will include dosage and administrative information, warnings and precautions, and drug interactions among other things.
PROP also requested that the FDA make a statement that opioid medications were not appropriate for moderate pain management.
The FDA also stresses on its website that they encourage individualized care for patients suffering from chronic pain conditions. They hope that this new labeling can help doctors create better plans in medical partnership with their patients.
The new opioid labels also include a neonatal warning indicating that children born to mothers taking opioid medications may have withdrawal symptoms after they are born. They also stressed that in spite of media coverage this withdrawal doesn’t mean the baby is addicted. However, withdrawal for a baby can be uncomfortable and stressful.
Overall, PROP is happy with the changes made by the FDA but they do feel the agency could have gone further. For example, the agency did not include immediate-release opioids in these changes even though the risks are the same.
The FDA is also calling for new research to be conducted on these drugs that can help drug manufacturers, doctors, and patients understand more of the risks. These post-market research programs were classified by the agency as “long-overdue.”
Will more effective opioid labeling measures help you better understand the risks of these medications?
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