Gabapentin (Neurotin)

Gabapentin has been prescribed by thousands of American psychiatrists for bipolar disorders without any scientific evidence of benefit.  They were urged to do so by over 40 open trials, many by psychiatrists from leading medical schools, claiming gabapentin appeared to be of value.  Now, three double-blind studies have come out finding no benefit from gabapentin for bipolar disorder.  There is even a court case in which an employee of the manufacturer claims that the manufacturer was illegally using open trials to promote gabapentin.  The FDA fined the manufacturer $200,000,000 for promoting gabapentin for bipolar disorder without obtaining FDA approval.

All of these issues and many of the open trials and double-blind trials are covered elsewhere on the website under Dubious Research on the webpage Gabapentin Scandal.  I urge you to read this sordid tale.  The entire field of psychiatry should be ashamed for its selling out to drug companies, which allowed this tragedy to occur.

At the present time, it can safely be said that gabapentin has no role in the treatment of bipolar disorder or any psychiatric disorder.  In my opinion, neither it nor any other medication should be given to a patient in clinical practice without at least one double-blind trial.  Patients are not guinea pigs.  Clinical practice is not research.  Signed informed consent should explain to patients if they are ever offered something not yet proven of value in at least one scientific study.

Gabapentin Withdrawal Case: An 81 year old women with a 5-year history of gabapentin use for enhanced bipolar control, who was tapered off of gabapentin over 1 week developed moderate upper respiratory tract infection symptoms and somatic complaints 1 day after termination of gabapentin. These worsened until 10 days at which time she acutely developed severe mental status changes, severe somatic chest pain, and hypertension. Upon reintroduction of gabapentin, the patient returned to baseline within 1-2 days. Gabapentin taper should follow a course similar to that of a benzodiazepine taper -- slowly and over a period of weeks to months. Gabapentin withdrawal syndrome in the presence of a taper. Tran KT, et al. University of Pittsburgh. . Bipolar Disord. 2005 Jun;7(3):302-4. Ed: The sick thing about this case is research shows that gabapentin is of no value for bipolar control.

Gabapentin No Value for Bipolars in DB; Placebo did Better!: DB PC using gabapentin 900-3600mg/d add-on to patients not well enough controlled on lithium, valproate, or both. Placebo patients actually did slightly better! Parke-Davis, Gabapentin in bipolar disorder: a placebo-controlled trial of adjunctive therapy. Gabapentin Bipolar Disorder Study Group. Pande AC, Crockatt JG, Janney CA, Werth JL, Tsaroucha G. Bipolar Disord 2000 Sep;2(3 Pt 2):249-55

Gabapentin No Value for Bipolars in DB, Lamotrigine Helps: DB PC 45 patients 6 weeks each. 51% lamotrigine, 28% gabapentin, 21% placebo response. NIMH, Clinical predictors of response to lamotrigine and gabapentin monotherapy in refractory affective disorders. Obrocea GV, Dunn RM, Frye MA, Ketter TA, Luckenbaugh DA, Leverich GS, Speer AM, Osuch EA, Jajodia K, Post RM. Biol Psychiatry 2002 Feb 1;51(3):253-60

Gabapentin No Value for Unipolars or Bipolars in DB, Lamotrigine Helps: DB PC 31 refractory unipolar and bipolar patients all given 6 week trial of lamotrigine, gabapentin, and placebo. NIMH, Frye MA, et al. A placebo-controlled study of lamotrigine and gabapentin monotherapy in refractory mood disorders. J Clin Psychopharmacol 2000 Dec;20(6):607-14

Gabapentin No Value in DB for Panic Disorder: Parke-Davis DB PC found no difference with a p=0.606! The drug company's "researchers" did a post-hoc analysis to tease out supposed benefits for patients with higher PAS (Panic & Agoraphobia Scale) scores (p<.04). Placebo-controlled study of gabapentin treatment of panic disorder. Pande AC, Pollack MH, Crockatt J, Greiner M, Chouinard G, Lydiard RB, Taylor CB, Dager SR, Shiovitz T. J Clin Psychopharmacol 2000 Aug;20(4):467-71

Gabapentin Helps Social Phobia a Little in DB: 69 pt 14 weeks DB PC 600-3600mg/d. p<0.05 only. Parke-Davis manufacturer study. Treatment of social phobia with gabapentin: a placebo-controlled study. Pande AC, Davidson JR, Jefferson JW, Janney CA, Katzelnick DJ, Weisler RH, Greist JH, Sutherland SM. J Clin Psychopharmacol 1999 Aug;19(4):341-8

Gabapentin Worthless for Alcohol Withdrawal in DB: A good German University of Essen DB PC study of 61 alcoholic patients going through alcohol withdrawal. Gabapentin was tested at 400mg qid as an add-on to clomethiazole. Treatment of acute alcohol withdrawal with gabapentin: results from a controlled two-center trial. Bonnet U, Banger M, Leweke FM, Specka M, Muller BW, Hashemi T, Nyhuis PW, Kutscher S, Burtscheidt W, Gastpar M. J Clin Psychopharmacol. 2003 Oct;23(5):514-9.

Use Off Label Only if Solid Research Support: Other unscientific uses besides bipolar supported only by open trials include complex regional pain syndrome, attention deficit disorder, trigeminal neuralgia, and alcohol withdrawal syndrome. The author states, "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). Managed care pharmacists should develop programs to restrict the use of gabapentin to these specific evidence-based situations." Examination of the evidence for off-label use of gabapentin. Mack A. J Manag Care Pharm. 2003 Nov-Dec;9(6):559-68