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. 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 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. 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 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. 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. Radley et al. indicated that gabapentin was among the medications with the highest proportion of off-label use, with 83% of its use being off label.9 Gabapentin was initially approved in Canada in April 1994 as adjunctive therapy for the management of epilepsy among patients over 18 years of age who are not controlled by conventional therapy.11 Because gabapentin is FDA approved for the treatment of postherpetic neuralgia in adults and as an adjunct therapy for the treatment of partial-onset seizures, the use of this medication for anything other than these indications is considered off-label. Our analysis compared study protocols for off-label use of gabapentin and the manufacturers' internal research reports with the published reports of study findings. The results of this analysis 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. This study examined off-label use of gabapentin for psychiatric indications and its concomitant use with CNS-D prescription drugs in a nationally representative sample of ambulatory care office visits. Less than 1% of outpatient gabapentin use was for FDA-approved indications. 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. Off-label prescribing does not necessarily signify that the medication is being used improperly, and in some cases, reliable research might validate its use. Nonetheless, prescribing gabapentin for off-label use might also result in negative consequences, including adverse drug effects, liability concerns, and a lack of reimbursement due to the 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. for an off-label use. Examples of Off-Label Medication Use for Mental Health Conditions . Amitriptyline • Insomnia • Posttraumatic stress disorder (PTSD) Clonidine • Smoking cessation • Excessive saliva caused by clozapine Gabapentin • Alcohol dependence • Social anxiety Prazosin • Post traumatic stress disorder 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 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). 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 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 In this nationally representative sample, <1% of outpatient gabapentin use was for approved indications. High concomitant use of CNS-D drugs and off-label gabapentin for psychiatric diagnoses underlines the need for improved communication about safety.
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