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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. 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 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 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. 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. 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. 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. The off-label use of gabapentin for indications not approved by the FDA should be reserved for cases where there is solid research support (e.g., diabetic neuropathy and prophylaxis of frequent migraine headaches). Off-Label Uses. Gabapentin is used off-label use for fibromyalgia, bipolar disorder, anxiety disorders, resistant depressants, mood disorders, irritable bowel syndrome, alcohol withdrawal, postoperative analgesia, migraine prophylaxis, interstitial cystitis, painful diabetic neuropathy, social phobia, generalized tonic-clonic seizures, pruritus 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. 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 Methods: National Ambulatory Care Medical Survey data (2011-2016) were used to identify encounters involving gabapentin (gabapentin visits) for adults (ages ≥18) (N=5,732). FDA-approved uses and off-label psychiatric use indications were identified with ICD-9-CM and ICD-10-CM diagnosis codes. CNS-D drugs examined were opioids, benzodiazepines Perhaps one of the more promising off-label uses for Gabapentin is for the treatment of anxiety disorders. There is mounting evidence that Gabapentin may be an effective intervention for various types of anxiety including: generalized anxiety disorder, social anxiety disorder, and panic disorder. Gabapentin was developed in 1993 and has indications for shingles (‘postherpetic neuralgia’) and partial-onset seizures. It has had a growing popularity in off-label uses for fibromyalgia, pain from a variety of causes, migraine, cocaine withdrawal, anxiety, and insomnia. Gabapentin has only three FDA indications: partial seizures, post-herpetic neuralgia, and restless legs syndrome (RLS). Off-label uses for gabapentin. Doctors often prescribe gabapentin off-label to treat conditions such as: pain from diabetic neuropathy, which is numbness or uncomfortable tingling caused by nerve damage from diabetes; nerve pain in the neck and back from conditions such as sciatica, a painful compression of the sciatic nerve Gabapentin has been approved by the United States (US) Food and Drug Administration (FDA) for postherpetic neuralgia and as adjunctive therapy for focal seizures. 1 However, a recent analysis of US physician office-based prescription practices between 2011 and 2016 found that less than one percent of gabapentin prescriptions are for such indications. 2 In 2020, gabapentin was reported to be 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 gabapentin in an evidence-based fashion, where literature exists to support such alternatives; and (5) encourage key clinicians and decision makers in managed We examined reporting practices for trials of gabapentin funded by Pfizer and Warner-Lambert's subsidiary, Parke-Davis (hereafter referred to as Pfizer and Parke-Davis) for off-label indications
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