Epileptic medications and suicidal risk

This just in from the FDA....

...in placebo-controlled trials of 11 different medications used to treat epilepsy (and other disorders as detailed in previous posts), individuals using these medications experienced twice the risk of suicidal thoughts and/or behaviors. It didn't take long for some, only a week, to experience this very significant side effect. The risk WAS higher for those given these medications for epilepsy than those given the medications for other reasons.

This is the FDA's list of medications evaluated in this study:

Carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (Felbatol)
Gabapentin (Neurontin)
Lamotrigine (Lamictal)
Levetiracetam (Keppra)
Oxcarbazepine (Trileptal)
Pregabalin (Lyrica)
Tiagabine (Gabitril)
Topiramate (Topamax)
Valproate (Depakote, Depakote ER, Depakene, Depacon)
Zonisamide ()

Here is the FDA reference for more information:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic


MY SOURCE: http://www.docguide.com/news/content.nsf/news/852571020057CCF6852573E1007057A9

Just a note from a nutritionist...fish oil can help reduce seizure activity. I AM NOT, I repeat AM NOT, advising anyone reading this post to discontinue their medications and replace them with a nutritional supplement. However, I AM encouraging you to discuss the possibility of a blend of nutrition therapy AND medication for a potentially gentler approach to safely managing a very serious medical issue.

Metabolic syndrome and psychiatric medications

I've been busy videotaping a home study course in my home office, but today it's pouring rain and I don't have enough light. It's a good time to get caught up on blogging.

One of the reasons I designed the home study course I'm videotaping is because of the rapid increase in the use of psychiatric medications for more than purely psychiatric reasons. The metabolic side effects of these medications caught a lot of health professionals off guard. Most nutrition professionals do not anticipate that they will be working in psychiatry when they decide to enter the field.

So people come into their office for help losing weight, and as well-intended as the professional in that office might be...they don't have all the information they need in order to provide the right kind of help.

Many psychiatric medications cause hormone changes, high cholesterol, diabetes, weight gain, and other changes. In women, this cluster of problems can also cause infertility. If you're reading this blog and it sounds like you might benefit from more information on eating well when you have this combination of problems to manage, I wanted to let you know about a second blog that I write. Its original intent is for women with polycystic ovary syndrome (PCOS), the infertility syndrome I just described. But the information is also very pertinent to others who may not be female or who may not be worried about fertility.

If you're interested, please visit us! www.incyst.blogspot.com

More about the ads

Hello everyone,

Just want to reassure you, my commitment to having appropriate ads is important to me. When I've had a chance I have been checking to see what's popping up...and I've been filtering out ads that are counterproductive to the mission of this blog.

I have seen some public service ads and some others for websites with good information, so I'm glad I took the chance to try this. But I don't want to turn people off on my concept before they've had a chance to benefit, because they feel like I'm using them for personal gain.

I can only see the ads that pop up when I look, so I welcome any feedback for ads you see that you'd rather not see when you're looking for the kind of information I provide.

I look forward to your feedback, have a wonderful week!

Monika

If you like the information you've been reading...

...I am putting the finishing touches on my 3rd version of "Nutritional Implications of Psychotropic Medications." It is a series of fact sheets on the hormonal and nutritional influences of medications designed to affect nervous system function. As of tonight, I have almost 200 pages of references alone, so I can guarantee you I was thorough.

I put this reference together when I became frustrated at the responses I was getting from drug companies to my questions about the relationship between some of these medications and changes in weight I and my colleagues were seeing. The answers were not always forthcoming, and I felt like individuals with mental health issues didn't really have anyone in the nutritional world to advocate for them. So...I developed this reference to help my colleagues become those advocates.

Because of the amount of time that I have put into this resource, I will need to raise the price by $15 on February 1. But since I finished it up a little bit early, I'm willing to keep the lower price until the officially announced release date.

For more information you can visit the link just above my photo to the left.

I hope I've created a product that helps you or someone you love!

Serious side effect warning for Chantix

Pfizer just issued a press release warning about potential serious side effects for their smoking cessation medication, Chantix (varenicline). These side effects include agitation, depression, suicidal thoughts and suicidal behaviors.

Here is a link to the original release:

http://www.docguide.com/news/content.nsf/news/852571020057CCF6852573D40053B3FA

Apparently when this drug was in the testing phase, individuals with psychiatric diagnoses were not included in the test population. In the world of pure study design, that makes sense...but...sigh...if you've ever worked in the world of psychiatric diagnoses or have one, you know how prevalent smoking is within this demographic.

Chantix is not a medication I regularly review, or plan to, but since my intended audience may very well be the population most at risk for experiencing the reported problems, I wanted to be sure this information reached its potentially most relevant audience.

The multi-talented Topamax?

I just finished adding new references to my Topamax page. I was surprised at how many off-label uses needed to be added to the list!

As I mentioned in an earlier post, off-label uses aren't a bad thing, provided the prescribing physician understands the rationale for the use and the patient understands the nature of off-label uses.

Here is my list, with references posted below.

Alcohol dependence, aggression, alternating hemiplegia, binge eating disorder, bipolar disorder, borderline personality disorder, catatonia, cerebellar tremors, chronic low back pain, chronic paroxysmal hemicrania, cocaine dependence, cyclic vomiting, depression, ejaculation pain, essential tremor, hemiballism, hemicrania continua, hemifacial spasm, idiopathic intracranial hypertension, impulsive behavioral disorders, infantile spasms, kleptomania, neuropathic pain, nicotine dependence, nocturnal eating, obesity, obsessive-compulsive disorder, paraphilic sexual disorders, paroxysmal kinesigenic choreoathetosis, pathologic gambling, pervasive developmental disorders, phrenic nerve palsy, post-traumatic stress disorder, Prader-Willi Syndrome, pseudotumor cerebri, restless legs syndrome, sexual compulsions, sleep-related eating disorder, smoking cessation, spinal myoclonus, trichotillomania.

Rubio G, Ponce G, Jimenez-Arriero MA, Palomo T, Manzanares J, Ferre F. Effects of topiramate in the treatment of alcohol dependence. Pharmacopsychiatry. 2004 Jan;37(1):37-40.

Heilig M, Egli M. Pharmacological treatment of alcohol dependence: target symptoms and target mechanisms. Pharmacol Ther 2006 Sep;111(3):855-76.

Collins GB, McAllister MS, Adury K. Drug adjuncts for treating alcohol dependence. Cleve Clin J Med 2006 Jul;73(7):641-4, 647-8, 650-1, passim.

Ma JZ, Ait Daoud N, Johnson BA. Topiramate reduces the harm of excessive drinking: implications for public health and primary care. Addiction 2006;Nov;101(11):1561-8.

Fernandez Miranda JJ, Marina Gonzalez PA, Montes Perez M, Diaz Gonzalez T, Gutierrez Cienfuegos E, Antuna Diaz MJ, Bobes Garcis J. Topiramate as add-on therapy in non-respondent alcohol dependant patients: a 12 month follow-up study. Actas Esp Psiquiatr 2007 Jul-Aug;35(4):236-42.

Hargreaves GA, McGregor IS. Topiramate moderately reduces the motivation to consume alcohol and has a marked antidepressant effect in rats. Alcohol Clin Exp Res 2007 Nov;31(11):1900-7.

Johnson BA. Update on neuropharmacological treatments for alcoholism: Scientific basis and clinical findings. Biochem Pharmacol 2008 Jan 1;75(1):34-56.

Johnson BA, Rosenthal N, Capece JA, Wiegand F, Mao L, Beyers K, McKay A, Ait Daoud N, Anton RF, Ciraulo DA, Kranzler HR, Mann K, O’Malley SS, Swift RM; Topiramate for Alcoholism Advisory Board; Topiramate for Alcoholism Study Group. Topiramate for treating alcohol dependence: a randomized controlled trial. JAMA 2007 Oct 10;298(14):1641-51.

Johnson BA. Topiramate-induced neuromodulation of cortico-mesolimbic dopamine function: a new vista for the treatment of comorbid alcohol and nicotine dependence? Addict Behav. 2004 Sep;29(7):1465-79.

Gobbi G, Gaudreau PO, Leblanc N. Efficacy of topiramate, valproate, and their combination on aggression/agitation behavior in patients with psychosis. J Clin Psychopharmacol 2006 Oct;26(5):467-73.

Navarro JF, Buron E, Martin Lopez M. Antiaggressive effects of topiramate in agonistic encounters between male mice. Methods Find Exp Clin Pharmacol 2007 Apr;29(3):195-8.

Nickel MK, Loew TH. Treatment of aggression with topiramate in male borderline patients, part II: 18-month follow-up. Eur Psychiatry 2007 Nov 14.

Jiang W, Chi Z, Ma L, Du B, Shang W, Guo H, Wu W. Topiramate: a new agent for patients with alternating hemiplegia of childhood. Neuropediatrics 2006 Aug;37(4):229-33.

Appolinario JC, McElroy SL. Pharmacological approaches in the treatment of binge eating disorder. Curr Drug Targets. 2004 Apr;5(3):301-7.

Zilberstein B, Pajecki D, Garcia de Brito AC, Gallafrio ST, Eshkenazy R, Andrade CG. Topiramate after adjustable gastric banding in patients with binge eating and difficulty losing weight. Obes Surg. 2004 Jun-Jul;14(6):802-5.

De Bernardi C, Ferraris S, D'Innella P, Do F, Torre E. Topiramate for binge eating disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2005 Feb;29(2):339-41. Epub 2004 Dec 28.

Kotwal R, Guerdjikova A, McElroy SL, Keck PE Jr. Lithium augmentation of topiramate for bipolar disorder with comorbid binge eating disorder and obesity. Hum Psychopharmacol 2006 Oct;21(7):425-31.

Tata AL, Kockler DR. Topiramate for binge-eating disorder associated with obesity. Ann Pharmacother 2006 Nov;40(11):1993-7.

McElroy SL, Hudson JI, Capece JA, Beyers K, Fisher AC, Rosenthal NR; Topiramate Binge Eating Disorder Research Group. Topiramate for the treatment of binge eating disorder associated with obesity: a placebo-controlled study. Biol Psychiatry 2007 May 1;61(9):1039-48.

Claudino AM, de Oliveira IR, Appolinario JC, Cordas TA, Duchesne M, Sichieri R, Bacaltchuk J. Double-blind, randomized, placebo-controlled trial of topiramate plus cognitive-behavior therapy in binge-eating disorder. J Clin Psychiatry 2007 Sep;68(9):1324-32.

Lykouras L, Hatzimanolis J. Adjunctive topiramate in the maintenance treatment of bipolar disorders: an open-label study. Curr Med Res Opin. 2004 Jun;20(6):843-7.

McDaniel WW, Spegel DR, Sahota AK. Topiramate effect in catatonia: a case series. J Neuropsychiatry Clin Neurosci 2006 Spring;18(2):234-8.

Sechi G, Agnetti V, Sulas FM, Sau G, Corda D, Pitzolu MG, Rosati G. Effects of topiramate in patients with cerebellar tremor. Prog Neuropsychopharmacol Biol Psychiatry 2003 Sep; 27(6): 1023-7.
M

uehlbacher M, Nickel MK, Kettler C, Tritt K, Lahmann C, Leiberich PK, Nickel C, Krawczyk J, Mitterlehner FO, Rother WK, Loew TH, Laplan P. Topiramate in treatment of patients with chronic low back pain: a randomized, double-blind, placebo-controlled study. Clin J Pain 2006 Jul-Aug;22(6):526-31.

Cohen AS, Goadsby PJ. Paroxysmal hemicrania responding to topiramate. J Neurol Neurosurg Psychiatry 2007 Jan;78(1):96-7.

Camarda C, Camarda R, Monastero R. Chronic paroxysmal hemicrania and hemicrania continua responding to topiramate: Two case reports. Clin Neurol Neurosurg 2008 Jan;110(1):88-91.

Kampman KM, Pettinati H, Lynch KG, Dackis C, Sparkman T, Weigley C, O'Brien CP. A pilot trial of topiramate for the treatment of cocaine dependence. Drug Alcohol Depend. 2004 Sep 6;75(3):233-40.

Sofuoglu M, Kosten TR. Novel approaches to the treatment of cocaine addiction. CNS Drugs. 2005;19(1):13-25.

Sofuoglu M, Kosten TR. Emerging pharmacological strategies in the fight against cocaine addiction. Expert Opin Emerg Drugs 2006 Mar;11(1):91-8.

Ohnez A, Kose G, Turanli G. Cyclic vomiting with generalized epileptiform discharges responsive to topiramate therapy. Pediatr Neurol 2006 Nov;35(5):348-51.

Jordi P, Maria-Jose A, Luis-Alfonso M, Mauro S. Management of ejaculation pain with topiramate: a case report. Clin J Pain. 2004 Sep-Oct;20(5):368-9.

Lyons K, Pahwa R, Comella CL, Eisa MS, Elble RJ, Fahn S, Jankovic J, Juncos JL, Koller WC, Ondo WG, Sethi KD, Stern MB, Tanner CM, Tintner R, Watts RL. Benefits and risks of pharmacological treatments for essential tremor. Drug Saf 2003; 26(7): 461-81.

Ondo WG, Jankovic J, Connor GS, Pahwa R, Elble R, Stacy MA, Koller WC, Schwarzman L, Wu SC, Hulihan JF; Topiramate Essential Tremor Study Investigators. Topiramate in essential tremor: a double-blind, placebo-controlled trial. Neurology 2006 Mar 14;66(5):672-7.

Gatto EM, Uribe Roca C, Raina G, Gorja M, Folgar S, Micheli FE. Vascular hemichorea/hemiballism and topiramate. Mov Disord. 2004 Jul;19(7):836-8.

Brighina F, Palermo A, Cosentino G, Fierro B. Prophylaxis of hemicrania continua: two new cases effectively treated with topiramate. Headache 2007 Mar;47(3):441-3.

Alonso Navarro H, Rubio L, Jimenez Jimenez FJ. Topiramate as treatment for hemifacial spasm. Clin Neuropharmacol 2007 Sep-Oct;30(5):308-9.

Palacio E, Rodero L, Pascual J. Topiramate-responsive headache due to idiopathic intracranial hypertension in Behcet syndrome. Headache. 2004 May;44(5):436-7.

Tang RA, Dorotheo EU, Schiffman JS, Bahrani HM. Medical and surgical management of idiopathic intracranial hypertension in pregnancy. Curr Neurol Neurosci Rep. 2004 Sep;4(5):398-409.

Celebisoy N, Gokcay F, Sirin H, Akyurekli O. Treatment of idiopathic intracranial hypertension: topiramate vs acetazolamide, an open-label study. Acta Neurol Scand 2007 Nov;116(5):322-7.

Dolengevich Segal H, Rodriguez Salgado B, Conejo Garcia A, San Sebastian Cabases J. [Efficacy of topiramate in children and adolescent with problems in impulse control: preliminary results]. Actas Esp Psiquiatr 2006 Jul-Aug;34(4):280-2.

Hosain SA, Merchant S, Solomon GE, Chutorian A. Topiramate for the treatment of infantile spasms. J Child Neurol 2006 Jan;21(1):17-9.

Hsieh MY, Lin KL, Wang HS, Chou ML, Hung PC, Chang MY. Low-dose topiramate is effective in the treatment of infantile spasms. Chang Gung Med J 2006 May-Jun;29(3):291-6.

Kwon YS, Jun YH, Hong YJ, Son BK. Topiramate monotherapy in infantile spasm. Yonsei Med J 2006 Aug 31;47(4):498-504.

Zou LP, Ding CH, Fang F, Sin NC, Mix E. Prospective study of first-choice topiramate therapy in newly diagnosed infantile spasms. Clin Neuropharmacol 2006 Nov-Dec;29(6):343-9.

Kaplan Y. Epilepsy and kleptomania. Epilepsy Behav 2007 Nov;11(3):474-5.

Chong MS, Libretto SE. The rationale and use of topiramate for treating neuropathic pain. Clin J Pain 2003 Jan-Feb; 19(1): 59-68.

Kline KM, Carroll DG, Malnar KF. Painful diabetic peripheral neuropathy relieved with use of oral topiramate. South Med J 2003 Jun; 96(6): 602-5.

Petit WA Jr., Upender RP. Medical evaluation and treatment of diabetic peripheral neuropathy. Clin Podiatr Med Surg 2003 Oct; 20(4): 671-88.

Vu TN. Current pharmacologic approaches to treating neuropathic pain. Curr Pain Headache Rep. 2004 Feb;8(1):15-8.

Bischofs S, Zelenka M, Sommer C. Evaluation of topiramate as an anti-hyperalgesic and neuroprotective agent in the peripheral nervous system. J Peripher Nerv Syst. 2004 Jun;9(2):70-8.

Benoliel R, Sharav Y, Eliav E. Painful posttraumatic trigeminal neuropathy: a case report of relief with topiramate. Cranio 2007 Jan;25(1):57-62.

Moulin DE, Clark AJ, Gilron I, Ware MA, Watson CP, Sessle BJ, Coderre t, Morley Forster PK, StinsonJ, Coulanger A, Peng P, Finley GA, Taenzer P, Squire P, Dion D, Cholkan A, Gilani a, Gordon A, Henry J, Jovey R, Lynch M, Mailis Gagnon A, Panju A, Rollman GB, Velly A; Canadian Pain Society. Pharmacological management of chronic neuropathic pain - consensus statement and guidelines from the Canadian Pain Society. Pain Res Manag 2007 Spring;12(1):13-21.

Codd EE, Martinez RP, Molino L, Rogers KE, Stone DJ, Tallarida RJ. Tramadol and several anticonvulsants synergize in attenuating nerve injury-induced allodynia. Pain 2007 May 24.

Winkelman JW. Treatment of nocturnal eating syndrome and sleep-related eating disorder with topiramate. Sleep Med 2003 May; 4(3): 243-6.

Gabriel A. Adjunctive topiramate treatment in refractory obese bipolar patients: a descriptive open label study. Eat Weight Disord 2007 Mar;12(1):48053.

Van Ameringen M, Mancini C, Patterson B, Bennett M. Topiramate augmentation in treatment-resistant obsessive-compulsive disorder: a retrospective, open-label case series. Depress Anxiety 2006;23(1):1-5.

Hollander E, Dell’Osso B. Topiramate plus paroxetine in treatment-resistant obsessive-compulsive disorder. Int Clin Psychopharmacol 2006 May;21(3):189-91.

Shiah IS, Chao CY, Mao WC, Chuang YJ. Treatment of paraphilic sexual disorder: the use of topiramate in fetishism. Int Clin Psychopharmacol 2006 Jul;21(4):241-3.

Huang YG, Chen YC, Du F, Li R, Xu GL, Jiang W, Huang J. Topiramate therapy for paroxysmal kinesigenic choreoathetosis. Mov Disord. 2005 Jan;20(1):75-7.

Dannon PN, Lowengrub K, Gonopolski Y, Musin E, Kotler M. Topiramate versus fluvoxamine in the treatment of pathological gambling: a randomized, blind-rater comparison study. Clin Neuropharmacol. 2005 Jan-Feb;28(1):6-10.

Hardan AY, Jou RJ, Handen BL. A retrospective assessment of topiramate in children and adolescents with pervasive developmental disorders. J Child Adolesc Psychopharmacol. 2004 Fall;14(3):426-32.

Khan S, Liberzon I. Topiramate attenuates exaggerated acoustic startle in an animal model of PTSD. Psychopharmacology (Berl). 2004 Mar;172(2):225-9. Epub 2003 Oct 30.

Asnis GM, Kohn SR, Henderson M, Brown NL. SSRIs versus non-SSRIs in post-traumatic stress disorder: an update with recommendations. Drugs. 2004;64(4):383-404.

Berlant JL. Prospective open-label study of add-on and monotherapy topiramate in civilians with chronic nonhallucinatory posttraumatic stress disorder. BMC Psychiatry. 2004 Aug 18;4(1):24.

Aalbersberg CF, Mulder JM. [Topiramate for the treatment of post traumatic stress disorder. A case study]. Tijdschr Psychiatr 2006;48(6):487-91.

Tucker P, Trautman RP, Wyatt DB, Thompson J, Wu SC, Capece JA, Rosenthal NR. Efficacy and safety of topiramate monotherapy in civilian posttraumatic stress disorder: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2007 Feb;68(2):201-6.

Smathers SA, Wilson JG, Nigro MA. Topiramate effectiveness in Prader-Willi syndrome. Pediatr Neurol 2003 Feb; 28(2): 130-3.

Shapira NA, Lessig MC, Lewis MH, Goodman WK, Driscoll DJ. Effects of topiramate in adults with Prader-Willi syndrome. Am J Ment Retard. 2004 Jul;109(4):301-9.

Alore PL, Jay WM, Macken MP. Topiramate, pseudotumor cerebri, weight-loss and glaucoma: an ophthalmologic perspective. Semin Ophthalmol 2006 Jan0Mar;21(1):15-7.

Perez Bravo A. [Topiramate use as treatment in restless legs syndrome] [Article in Spanish] Actas Esp Psiquiatr. 2004 May-Jun;32(3):132-7.

Khazaal Y, Cornuz J, Bilancioni R, Zullino DF. Topiramate for smoking cessation. Psychiatry Clin Neurosci 2006 Jun;60(3):384-8.

Winkleman JW. Treatment of nocturnal eating syndrome and sleep-related eating disorder with topiramate. Sleep Med 2003 May; 4(3): 243-6.
Winkelman JW.

Efficacy and tolerability of open-label topiramate in the treatment of sleep-related eating disorder: a retrospective case series. J Clin Psychiatry 2006 Nov;67(11):1729-34.

Martinez Salio A, Soler Algarra S, Calvo Garcia I, Sanchez Martin M. [Nocturnal sleep-related eating disorder that responds to topiramate]. Rev Neurol 2007 Sep 1-15;45(5):276-9.

Siniscalchi A, Mancuso F, Russo E, Ibbadu GF, De Sarro G. Spinal myoclonus responsive to topiramate. Mov Disord. 2004 Nov;19(11):1380-1.

Lochner C, Seedat s, Niehaus DJ, Stein DJ. Topiramate in the treatment of trichotillomania: an open-label pilot study. Int Clin Psychopharmacol 2006 Sep;21(5):255-9.

How effective is your medication....REALLY?

The New York Times today reports that drug researchers are more likely to publish data reporting positive effects of medications than they are negative ones. Here's the full story for any of you who are interested.

http://www.nytimes.com/2008/01/17/health/17depress.html?_r=1&th&emc=th&oref=slogin

This disturbs me. My graduate school program taught me that ANY outcome, positive, negative, or neutral, is significant to consider and report to colleagues. In the pharmaceutical industry, it would seem to me that recognizing that a medication is not as effective, in the development stage, would save money in the long run. There is always time to go back to the drawing board and build a better mousetrap.

Is it only me who gets tired of turning on the news and hearing that a medication was recalled for side effects/problems that could have been headed off with a little patience and integrity on the front end?

Understanding why a medication isn't effective should be challenging scientists to better understand the brain and develop medications that are effective.

In mental health, especially, it can be dangerous to convince someone with depression, bipolar disorder, or schizophrenia, that a medication that they are taking is more likely to help them than it really is. Self-destructive behaviors, not to mention suicide and homicide, hurt more than just the person taking the ineffective medication.

I understand that medications cannot even be developed if there is not a way to pay for the cost of research, development, production, and distribution. But c'mon, colleagues, aren't we also in this work, at least a little bit, to perform a public service? Isn't the better public service to steer people away from nonproductive choices (including medications that are not likely to help) and challenging ourselves to find newer, better options that can truly make a difference? Even if it it means exercising humility and admitting we may not have gotten it right the first time?

Thomas Edison had to go back to the lab many times before he successfully created an invention as simple as a light bulb that actually worked. To think we can always develop a medication that positively impacts something as awesome and complex as the human brain, on the very first try, well, I don't know about you, but I prefer humility.

A little slower pace in the development stage to be sure our talents are actually helping people (those with mental health diagnoses) who can have a hard time finding advocates who take them and their safety seriously...is not just an ethical issue. Even for those concerned mainly with with profits, proactive thinking can prevent having to spend money on recalls and litigation, improving profitability in the long run.