Monday, January 14, 2008

Is Fibromyalgia A Real Disease? Does It Need Its Own Medication?

If you are interested in this debate, you may be interested in this New York Times article that was published today:

Lyrica (pregabalin), the medication that is mentioned in this article, is a medication I've been researching for my psychotropic medication publication. This drug was first approved for use in the US in 2005, for the treatment of epilepsy, diabetic neuropathy pain and post-herpetic neuralgia. In 2007 it was also approved for treating fibromyalgia.

In addition, in my own research, I found publications describing 10 off-label (non-FDA approved)uses for this medication. One of these off-label uses, anxiety disorder, is actually an approved use in the European Union but not the United States. The references for these off-label uses, excerpted from my CD, are posted below.

Pregabalin is supposedly a more potent form of another popular medication, gabapentin (Neurontin). The use of this medication has been questioned, as at one point, it was estimated that 90% of its prescriptions were written for off-label uses. From what I could see when I was researching pregabalin, the trend with the newer version is not dissimilar.

From a biochemical standpoint, many of the off-label uses do make sense, as many of these issues have very similar biochemical origins. Off-label uses are not always inappropriate. However, it is important to make sure you know exactly WHY you are being prescribed a medication. You are entitled to ask your physician whether or not the medication you are being prescribed is FDA approved for your diagnosis, or if the use she is asking you to try is off-label. It's your body, and you have a right to make the most informed decision possible.


Jatzko A, Stegmeier Petroianu A, Petroianu GA. Alpha-2-delta ligands for singultus (hiccup) treatment: three case reports. J Pain Symptom Manage 2007 Jun;33(6):756-60.
Yokoyama T, Maeda Y, Audette KM, Sluka KA.Pregabalin reduces muscle and cutaneous hyperalgesia in two models of chronic muscle pain in rats. J Pain 007 May;8(5):422-9.

Zesiewicz TA, Ward CL, Hauser RA, Pease Campbell JA, Sullivan KL. Pregabalin (Lyrica) in the treatment of essential tremor. Mov Disord 2007 Jan;22(1):139-41.
Zesiewicz TA, Ward CL, Hauser RA, Salemi JL, Siraj S, Wilson MC, Sullivan KL. A pilot, double-blind, placebo-controlled trial of pregabalin (Lyrica) in the treatment of essential tremor. Mov Disord 2007 Jun 19.

Maizels M, McCarberg B. Antidepressants and antiepileptic drugs for chronic non-cancer pain. Am Fam Physician 2005 Feb 1;71(3):483-90.

Crofford LJ, Rowbotham MC, Mease PJ, Russell IJ, Dworkin RH, Corbin AE, Young JP, LaMoreaux LK, Martin SA, Sharma U,Pregabalin 1008-105 Study Group. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2005 Apr;52(4):1264-73.
Rooks DS. Fibromyalgia treatment update. Curr Opin Rheumatol 2007 Mar;19(2):111-7.

Owen RT. Pregabalin: Its efficacy, safety and tolerability profile in fibromyalgia syndrome. Drugs Today (Barc). 2007 Dec;43(12):857-63.

Pande AC, Crockatt JG, Feltner DE, Janney CA, Smith WT, Weisler R, Londborg PD, Bielski RJ, Zimbroff DL, Davidson JR, Liu Dumaw M. Pregabalin in generalized anxiety disorder: a placebo-controlled trial. Am J Psychiatry 2003 Mar;160(3):533-40.

Van Ameringen M, Mancini C, Pipe B, Bennett M. Antiepileptic drugs in the treatment of anxiety disorders: role in therapy. Drugs 2004;64(19):2199-220.

Baldwin DS, Polkinghorn C. Evidence-based pharmacotherapy of Generalized Anxiety Disorder. Int J Neuropsychopharmacol 2005 Jun;8(2):293-302.

Pohl RB, Feltner DE, Fieve RR, Pande AC. Efficacy of pregabalin in the treatment of generalized anxiety disorder: double-blind, placebo-controlled comparison of BID versus TID dosing. J Clin Psychopharmacol 2005 Apr;25(2):151-8.

Rickels K, Pollack MH, Feltner DE, Lydiard RB, Zimbroff DL, Bielski RJ, Tobias K, Brock JD, Zornberg GL, Pande AC. Pregabalin for treatment of generalized anxiety disorder: a 4-week, multicenter, double-blind, placebo-controlled trial of pregabalin and alprazolam. Arch Gen Psychiatry 2005 Sep;62(9):1022-30.

Keck PE, Strawn JR, McElroy SL. Pharmacologic treatment considerations in co-occurring bipolar and anxiety disorders. J Clin Psychiatry 2006;67 Suppl 1:8-15.

Montgomery SA, Tobias K, Zornberg GL, Kasper S, Pande AC. Efficacy and safety of pregabalin in the treatment of generalized anxiety disorder: a 6-week, multicenter, randomized, double-blind, placebo-controlled comparison of pregabalin and venlafaxine. J Clin Psychiatry 2006 May;67(5):771-82.

Frampton JE, Foster RH. Pregabalin: in the treatment of generalised anxiety disorder. CNS Drugs 2006;20(8):685-93.

Montgomery SA. Pregabalin for the treatment of generalised anxiety disorder. Expert Opin Pharmacother 2006 Oct;7(15):2139-54.

Bendelow B, Wedekind D, Leon T. Pregabalin for the treatment of generalized anxiety disorder: a novel pharmacologic intervention. Expert Rev Neurother 2007 Jul;7(7):769-81.

Owen RT. Pregabalin: its efficacy, safety and tolerability profile in generalized anxiety. Drugs Today (Barc). 2007 Sep;43(9):601-10.

Kitchener JM. Glossopharyngeal neuralgia responding to pregabalin. Headache 2006 Sep;46(8):1307-8.

Hurley RW, Chatterjea D, Rose Feng M, Taylor CP, Hammond DL. Gabapentin and pregabalin can interact synergistically with naproxen to produce antihyperalgesia. Anesthesiology 2002 Nov;97(5):1263-73.

Field MJ, Holloman EF, McCleary S, Hughes J, Singh L. Evaluation of gabapentin and S-(+)-3-isobutylgaba in a rat model of postoperative pain. J Pharmacol Exp Ther 1997 Sep;282(3):1242-6.

Jones DL, Sorkin LS. Systemic gabapentin and S(+)-3-isobutyl-gamma-aminobutyric acid block secondary hyperalgesia. Brain Res 1998 Nov 9;810(1-2):93-9.

Hill CM, Balkenohl M, Thomas DW, Walker R, Mathe H, Murray G. Pregabalin in patients with postoperative dental pain. Eur J Pain 2001;5(2):119-24.

Sommer M, Bachmann CG, Liebetanz KM, Schindehutte J, Tings T, Paulus W. Pregabalin in restless legs syndrome with and without neuropathic pain. Acta Neurol Scand 2007 May;115(5):347-50.

Jefferson JW. Benzodiazepines and anticonvulsants for social phobia (social anxiety disorder). J Clin Psychiatry 2001;62 Suppl 1:50-3.

Pande AC, Feltner DE, Jefferson JW, Davidson JR, Pollack M, Stein MB, Lydiard RB, Futterer R, Robinson P, Slomkowski M, DuBoff E, Phelps M, Janney CA, Werth JL. Efficacy of the novel anxiolytic pregabalin in social anxiety disorder: a placebo-controlled, multicenter study. J Clin Psychopharmacol 2004 Apr;23(2):141-9.

Muller JE, Koen L, Seedat S, Stein DJ. Social anxiety disorder : current treatment recommendations. CNS Drugs 2005;19(5):377-91.

Cottraux J. Recent developments in research and treatment for social phobia (social anxiety disorder). Curr Opin Psychiatry 2005 Jan;18(1):51-4.

Davidson JR. Pharmacotherapy of social anxiety disorder: what does the evidence tell us? J Clin Psychiatry 2006;67 Suppl 12:20-6.

Davidson JR. Pharmacotherapy of social phobia. Acta Psychiatr Scand Suppl 2003;(417):65-71.


Social Skills said...

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