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We selected gabapentin (Neurontin), a medication reported to be widely used off label, as a specific example to explore specialist physicians' experiences with off-label prescribing. In addition to being used to treat pain, gabapentin is used off label to treat anxiety, alcohol use disorder (AUD), alcohol withdrawal, depression, substance use disorders (SUDs), sleep problems, and more. Such materials include unabridged reprints or copies of peer reviewed studies published in scientific or medical journal articles indexed by the National Library of Medicine at the National Institutes of Health, with the content of the article not focusing on off-label use. Kaufman R. The Neurontin Controversy: The Saga of Off-Label Drug Off-label: It is estimated that approximately 9/10 prescriptions for Gabapentin are “off-label” or for conditions that the drug isn’t approved to treat. Off-label prescriptions have a reduce chance of actually working for the treatment of anxiety. Gabapentin is widely prescribed off label in medical practice, including psychiatry. The U.S. Food and Drug Administration (FDA) warned of risks associated with gabapentin combined with central nervous system depressant (CNS-D) drugs, which are commonly prescribed in psychiatric treatment. Vedula SS, Bero L, Scherer RW, et al. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med. 2009;361(20):1963-1971. Goodman CW, Brett AS. A clinical Neurontin was launched into the marketplace in February of 1994; from mid-1995 to at least 2001, the growth of off-label sales was tremendous. While not all of these sales were the consequence of Warner-Lambert’s illegal marketing, the marketing scheme was very successful in increasing Neurontin prescriptions for unapproved uses. off-label experimentation with gabapentin commenced for neuropathic pain, bipolar disorder, and migraine prophylaxis (6). The sustained upward trend in off-label prescribing of gabapentin is concerning, considering the minimal high-quality evidence for many off-label uses. Recent attention to off-label use of gabapentin is largely Off-label gabapentin (Neurontin) got a bad rep when it missed the mark in bipolar disorder, but there may be something worth salvaging in this drug. Here, we weigh its pros and cons for anxiety, substance use disorders, sleep, pain, and hot flashes, and compare it to its underutilized cousin, pregabalin (Lyrica). Gabapentin is widely used in the United States for a number of off-label indications, often as an alternative to opioid therapy. Increasing evidence has emerged suggesting that gabapentin may not be as benign as once thought and may be associated with substance abuse in concert with opioids. Gabapentin (Neurontin) is FDA approved to treat seizure disorder and nerve pain from shingles. But it’s also used off-label to treat many other conditions, including anxiety, nerve pain from diabetes, and hot flashes. Gabapentin may be effective for anxiety, but it’s usually not a first-choice medication for this use. Gabapentin’s off-label uses—meaning prescribing gabapentin for a problem not on the FDA approval list for this medication—that physicians are finding include: Alcohol withdrawal; Anxiety; Cocaine withdrawal; Fibromyalgia; Headaches; Hiccups; Hot flashes; Hyperhidrosis; Insomnia; Migraines; Mood disorders; Pain syndromes; Peripheral Gabapentin is widely used in the United States for a number of off-label indications, often as an alternative to opioid therapy. Increasing evidence has emerged suggesting that gabapentin may not be as benign as once thought and may be associated with substance abuse in concert with opioids. In addition to these FDA-approved uses, doctors sometimes prescribe gabapentin off-label. Off-label use means there is some evidence to show that a drug may be medically appropriate to treat conditions other than those for which it was approved. Gabapentin is sold under the brand name Neurontin and is available as a generic product as well. The rise in gabapentin prescribing is multifactorial but thought to be due in part to efforts by the pharmaceutical industry to promote the use of the medication for off-label uses. (In 2004, the manufacturer of Neurontin, Pfizer, pleaded guilty to multiple counts of illegally promoting the off-label use of gabapentin, resulting in nearly $430 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. OBJECTIVES: (1) Describe the relevance of off-label use of gabapentin to man-aged care pharmacy; (2) summarize recent FDA warnings and media reports related to off-label gabapentin use; (3) review medical information pertaining to the off-label use of gabapentin; (4) outline alternatives to off-label use of Choosing gabapentin and pregabalin: These drugs are widely used off-label as an alternative to benzodiazepines for anxiety disorders. The speed of their onset of action has not been clearly established, but many clinicians have the impression that it is often within a few days, much shorter than that for antidepressants. We examined clinical trials of gabapentin (Neurontin, Pfizer) for off-label use for migraine prophylaxis, bipolar disorders, neuropathic pain, or nociceptive pain. Outcomes described in published 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.
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