1. Pink Sheet

Gabapentin Petition Could Give FDA Opportunity to Revisit Tradeoffs In Opioid Oversight Debate

 
• By Sarah Karlin-Smith

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.

DEA logo on wall
Public Citizen Wants FDA and DEA to place gabapentin in schedule V • Source: Alamy

Public Citizen is petitioning the US Food and Drug Administration and Drug Enforcement Administration to place gabapentin into schedule V of the Controlled Substances Act due to the drug's potential for abuse with serious consequences that include psychological effects, physical dependence, seizures, suicide and overdose death.

The 9 February request will give FDA another chance to consider how to balance individual patient need and access...

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