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Special Communication
Less Is More
March 25, 2019

A Clinical Overview of Off-label Use of Gabapentinoid Drugs

Author Affiliations
  • 1Department of Medicine, University of South Carolina School of Medicine, Columbia
JAMA Intern Med. 2019;179(5):695-701. doi:10.1001/jamainternmed.2019.0086

Background  The gabapentinoid drugs gabapentin and pregabalin were originally developed as antiseizure drugs but now are prescribed mainly for treatment of pain. For gabapentin, the only pain-related indication approved by the US Food and Drug Administration (FDA) is postherpetic neuralgia. For pregabalin, FDA-approved indications related to pain are limited to postherpetic neuralgia, neuropathic pain associated with diabetic neuropathy or spinal cord injury, and fibromyalgia. Despite these limited indications, gabapentin and pregabalin are widely prescribed off-label for various other pain syndromes. Such use is growing, possibly because clinicians are searching increasingly for alternatives to opioids.

Observations  This report summarizes the limited published evidence to support off-label gabapentinoid uses, describes clinical cases in which off-label use is problematic, and notes how review articles and guidelines tend to overstate gabapentinoid effectiveness.

Conclusions  Clinicians who prescribe gabapentinoids off-label for pain should be aware of the limited evidence and should acknowledge to patients that potential benefits are uncertain for most off-label uses.

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2 Comments for this article
Excellent review shows the truth.
Clive Sinoff |
Drs. Goodman and Brett have done an excellent review about the lack of efficacy and adverse effects of gabapentinoids, even in FDA approved conditions. They are essentially useless for somatic pain and infrequently beneficial for neuropathic pain, with significant adverse effects. This can be easily gleaned by listening to patients with an open mind.
Cheaper and probably more efficacious , are older drugs including tricyclic antidepressants and possibly the SNRIs. They are cheaper and the side effects are more easily managed. As discussed in the review, gabapentinoids have been "hyped" and, in my opinion, should largely disappear from clinical
Extreme caution with this caution
Heath Mc Anally, MD, MSPH | Northern Anesthesia & Pain Medicine, LLC
I respectfully disagree with the comment by Sinoff.  The TCAs can be very sedating, anticholinergic of course increasing the risk of dementia, etc., pro-dysrhythmic, and come with all sorts of P450 interaction concerns. Gabapentin and pregabalin lack both of the latter two risks, not to mention the risk of hyper-serotonergism that is rampant these days with patients on multiple antidepressants, triptans, cyclobenzaprine, etc. In the course of nearly twenty years of anesthesia and pain medicine, my experience (and that of many of my colleagues) is that the gabapentinoids have tremendous efficacy, safety and utility, especially in the era of looking for opioid alternatives. Do they carry risk? Of course. Good risk stratification is essential. But to castigate the class like this is irresponsible. That's like saying NSAIDs "should largely disappear from clinical practice" because they can be overused and confer risks.