While some studies show opioids are ineffective for pain after 12 weeks, conclusive research on the topic is limited. The FDA-mandated research will focus on all immediate, long-acting and extended-release opioids prescribed to patients for use outside of healthcare settings.
“We are going to impose a mandate on existing products … to answer the question that people have been posing for years: whether you have declining efficacy, and whether that declining efficacy can lead to addiction,” FDA Commissioner Scott Gottlieb, MD, told The Washington Post.
If the research points to opioids’ ineffectiveness, the agency could make labeling changes, implement special prescribing and dispensing rules, or even prohibit their use, according to Dr. Gottlieb.
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