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February 27, 2018

Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Evaluation Efforts

Author Affiliations
  • 1Collaboration for Research Integrity and Transparency, Yale Law School, New Haven, Connecticut
  • 2Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut
  • 3Associate Editor, JAMA Internal Medicine
JAMA. 2018;319(8):776-778. doi:10.1001/jama.2017.21897

In December 1993, the US Food and Drug Administration (FDA) granted approval for gabapentin, under the brand name Neurontin, for adjunctive therapy of partial seizures. Subsequently, the FDA approved gabapentin in 2000 for treatment of partial seizures in children aged 3 years or older and in 2002 for treatment of postherpetic neuralgia. However, over the past 25 years, gabapentin has been prescribed for a variety of indications beyond those formally evaluated by the FDA.

In this issue of JAMA, Moore et al1 summarize an updated Cochrane review on the use of gabapentin for neuropathic pain. The authors concluded that gabapentin is associated with reduction in acute pain associated with postherpetic neuralgia and peripheral diabetic neuropathy (the later indication is not approved by the FDA), and that there is limited evidence to support the use of gabapentin for other types of neuropathic pain and pain disorders.1 This Editorial outlines the history of gabapentin availability in the US market, and recommends regulatory requirements and postmarketing surveillance initiatives that could help ensure that evidence to support new uses of approved medical products is coordinated, expeditiously generated, rigorously developed, and reliably reported to patients and clinicians.