US FDA Learns 'Lessons Of History,' Takes Opioid Fight To Gabapentinoids
Agency investigating potential misuse and abuse of gabapentinoids, which CDC had recommended as alternative to opioids, in latest twist to epidemic.
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Public Citizen’s request to place gabapentin on DEA’s controlled substances list may be a test case for how much weight FDA plans to give to broader public health impacts of drug approvals as opposed to the risk-benefit calculus for individual patients for whom a drug is labeled.
FDA advisory committee members raise concerns about inappropriate marketing and prescribing practices.
Mandatory training could be reserved for physicians who want to prescribe opioids for longer-term use, as opposed to those who would prescribe recommended amounts in blister packs; evidence that blister packs would affect prescribing still is needed, however.