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

Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Evaluation Efforts Opinion EDITORIAL Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Evaluation Efforts Joshua D. Wallach, MS, PhD; Joseph S. Ross, MD, MHS In December 1993, the US Food and Drug Administration (FDA) potentially providing opportunities to expand postmarket- ing evaluation efforts. Between 1995 and 2004, before com- granted approval for gabapentin, under the brand name Neurontin, for adjunctive therapy of partial seizures. Subse- petition from generic drugs, gabapentin sales increased from quently, the FDA approved $98 million to nearly $3 billion per year. During this time, gabapentin in 2000 for treat- gabapentin was used to treat conditions as varying as fibro- ment of partial seizures in myalgia and other chronic pain syndromes, psychiatric disor- Related article page 818 children aged 3 years or older ders, and migraine headaches, all off-label uses at the discre- and in 2002 for treatment of postherpetic neuralgia. How- tion of physicians that have not been formally approved ever, over the past 25 years, gabapentin has been prescribed by the FDA. By 2000, gabapentin was the top-selling anticon- for a variety of indications beyond those formally evaluated vulsant and ranked 17th for total expenditures among by the FDA. all drugs. In this issue of JAMA,Mooreetal http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

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

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Publisher
American Medical Association
Copyright
Copyright 2018 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
D.O.I.
10.1001/jama.2017.21897
Publisher site
See Article on Publisher Site

Abstract

Opinion EDITORIAL Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Evaluation Efforts Joshua D. Wallach, MS, PhD; Joseph S. Ross, MD, MHS In December 1993, the US Food and Drug Administration (FDA) potentially providing opportunities to expand postmarket- ing evaluation efforts. Between 1995 and 2004, before com- granted approval for gabapentin, under the brand name Neurontin, for adjunctive therapy of partial seizures. Subse- petition from generic drugs, gabapentin sales increased from quently, the FDA approved $98 million to nearly $3 billion per year. During this time, gabapentin in 2000 for treat- gabapentin was used to treat conditions as varying as fibro- ment of partial seizures in myalgia and other chronic pain syndromes, psychiatric disor- Related article page 818 children aged 3 years or older ders, and migraine headaches, all off-label uses at the discre- and in 2002 for treatment of postherpetic neuralgia. How- tion of physicians that have not been formally approved ever, over the past 25 years, gabapentin has been prescribed by the FDA. By 2000, gabapentin was the top-selling anticon- for a variety of indications beyond those formally evaluated vulsant and ranked 17th for total expenditures among by the FDA. all drugs. In this issue of JAMA,Mooreetal

Journal

JAMAAmerican Medical Association

Published: Feb 27, 2018

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