Fibromyalgia drugs

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Fibromyalgia drugs include prescription drugs currently approved or used off-label for Fibromyalgia (FM/FMS), and experimental drugs under investigation.

There are currently three FDA approved drugs for fibromyalgia:

FDA approved[edit | edit source]

Fibromyalgia Drugs - FDA Approved
Brand Name Drug

Overview

Generic Drug

Overview

Side Effects

and

Interactions

More on Side Effects and Interactions

Not all side effects or possible drug interactions of brand name or generic name drugs are listed or linked in this chart.

Cymbalta[2] Duloxetine[3] Cymbalta[4][5]

Duloxetine[6][7]

  • Cymbalta is facing lawsuits due to severe withdrawal symptoms.[8] Eli Lilly has settled hundreds of personal injury lawsuits with patients experiencing severe withdrawal symptoms.[citation needed]
Lyrica Pregabalin (2019)[9] Lyrica[10][11]
  • Severe weight gain
Savella[12] Milnacipran[13] Savella[14][15]

Milnacapiran[16][17]

Off-label[edit | edit source]

Off-label Drugs Used For Fibromyalgia
Brand Name

Drug

Overview

Generic Drug

Overview

Off-label Use Side Effects

and

Interactions

More on Side Effects and Interactions

Not all side effects or possible drug interactions of brand name or generic name drugs are listed or linked in this chart. Brands and their generics can have different side effects and interactions. Review EACH brand name and EACH generic name medication's side effects and possible drug interactions with your doctor and pharmacist.

Florinef[18] Fludrocortisone Orthostatic intolerance and POTS Florinef[19][20]

Fludrocortisone[21][22]

  • Interacts with many other medications
Neurontin Gabapentin Pain, sleep Neurontin[23][24]

Gabapentin[25][26]

  • Weight gain
Remeron[27] Mirtazapine Chronic insomnia Remeron[28][29]

Mirtazapine[30][31]

ReVia, Vivitrol[32] Low-dose naltrexone (LDN) Pain, positive mood, sleep quality, and fatigue[33][34] Revia[35][36]

Low dose naltrexone (LDN)[37][38]

  • Must be stepped up slowly
  • Opioids will be rendered ineffective
Seroquel (low dose)[39] Quetiapine (low dose)[40] Chronic insomnia Seroquel[41][42] Quetiapine (low dose)[43][44]
  • Although prescribed for insomnia it is not recommended for this off-label use.[45][46]
Ultram, ConZip, Qdolo[47] Tramadol Pain Ultram[48][49]
Tramadol[50][51]
  • Tramadol induced seizure: A 3-year study[52]
  • Seizures[citation needed]
Zanaflex[53] Tizanadine[54] Chronic insomnia Zanaflex[55][56]

Tizanidine[57][58]

Sleep medications[edit | edit source]

Brands and their generics can have different side effects and interactions. Review EACH brand name and EACH generic name medication's side effects and possible drug interactions with your doctor and pharmacist.

Sleep dysfunction is a prominent symptom in FM. There are several types of sleep medications used for FM; antihistamines, benzodiazepines, nonbenzodiazepines, sedating antidepressants and sedating antipsychotics.[59]

Drug trials[edit | edit source]

  • ASP8062
  • 2017, A Phase 2a, Randomized, Double-Blind Placebo-controlled, Parallel-group Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia[60]
  • 2017, Intec Pharma Launches Phase 1 Trial of Cannabinoid-based Therapy for Fibromyalgia, Lower Back Pain.[citation needed][61]
  • 2016, The Pridgen Revolution? Dr. Pridgen on Bringing His Antiviral Approach to Fibromyalgia To Market [62]
Almost three years ago, Dr. Pridgen threatened to turn the world of fibromyalgia treatment on its head. Few had connected fibromyalgia with viruses or even immune problems when Pridgen announced that a) FM is caused herpes simplex virus reactivation and b) that it could be treated with antivirals.[62]
  • 2016, Novel Fibromyalgia Treatment Granted FDA Fast Track Designation[citation needed][63]
In the successful Phase II trial in fibromyalgia, IMC-1 was studied to confirm the hypothesis that chronic tissue-resident herpes simplex virus type 1 (HSV-1) may be one of the underlying causes of fibromyalgia and causally related to fibromyalgia symptoms or recurrence. IMC-1 is a novel fixed-dose oral combination antiviral medication designed to suppress this suspected virus and thus alleviate fibromyalgia symptoms.[citation needed][63]
  • 2017, Through the “Valley of Death”: Dr. Pridgen, Fibromyalgia and the Looming Trials[64]
First there were the anecdotal reports – FM patients were not just getting better but some, and not just a few, were getting well using something entirely new – an antiviral protocol, of all things, created not by a pain specialist or rheumatologist but by a surgeon.[64]
  • 2017, A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia[65]
IMC-1 was efficacious and safe in treating symptoms of fibromyalgia, supporting the hypothesis that herpes virus infections may contribute to this syndrome. Improved retention rates, decreased adverse event rates, and evidence of efficacy on a broad spectrum of outcome measures are suggestive that IMC-1 may represent an effective, novel treatment for fibromyalgia.[65]


Drug trials failed and drugs abandoned[edit | edit source]

  • TNX-102
  • 2016, The drug failed in its primary goal in providing pain relief and Tonix Pharmaceuticals will not be moving forward in developing a Ffbromyalgia drug.[citation needed][66]
  • Phase III clinical trial of DS-5565 found ineffective
  • 2017, The Big Hurt: Second Major Fibromyalgia Drug in a Year Fails[67]
In the three 13-week, double-blind, global, phase 3 ALDAY clinical trials evaluating Mirogabalin for the treatment of pain associated with fibromyalgia, Mirogabalin did not meet the primary efficacy endpoint to demonstrate a statistically significant reduction in the weekly average of worst daily pain score from baseline to Week 13.[67]
  • Bacille Calmette-Guerin (BCG) vaccine
  • 2017, Century-old vaccine gives new hope to fibromyalgia community[citation needed][68]
  • 2018, FDA gives approval for clinical trial.

See also[edit | edit source]

Learn more[edit | edit source]

References[edit | edit source]

  1. "Medications for Treating Fibromyalgia Symptoms". Arthritis Foundation. October 13, 2022.
  2. "Cymbalta Uses, Dosage, Side Effects & Warnings - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  3. "Duloxetine: Uses, Side Effects, Dosage, Warnings - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  4. "Cymbalta Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  5. "Cymbalta Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  6. "Duloxetine Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  7. "Duloxetine Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  8. Miller, Emily. "Cymbalta Lawsuit - Settlements, Withdrawal & Suicide Claims". Drugwatch.com. Retrieved August 21, 2018.
  9. "Court Blocks Sale of Generic Lyrica, Upholds Pfizer Patents - Non-opioid Pain Medication - Chronic Pain". HealthCentral. Retrieved August 21, 2018.
  10. "Lyrica Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  11. "Lyrica Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  12. "Savella (milnacipran) Uses, Dosage, Side Effects - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  13. "Milnacipran Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  14. "Savella Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  15. "Savella Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  16. "Milnacipran Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  17. "Milnacipran Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  18. "Florinef Dosage Guide - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  19. "Florinef Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  20. "Florinef Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  21. "Fludrocortisone Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  22. "Fludrocortisone Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  23. "Neurontin Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  24. "Neurontin Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  25. "Gabapentin Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  26. "Gabapentin Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  27. "Remeron: Side Effects, Dosage & Uses - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  28. "Remeron Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  29. "Remeron Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  30. "Mirtazapine Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  31. "Mirtazapine Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  32. "ReVia Uses, Side Effects & Warnings - Drugs.com". Drugs.com. Retrieved September 4, 2018.
  33. Younger, Jarred; Noor, Noorulain; McCue, Rebecca; Mackey, Sean (January 28, 2013). "Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels". Arthritis & Rheumatism. 65 (2): 529–538. doi:10.1002/art.37734. ISSN 0004-3591.
  34. "Low Dose Naltrexone for Fibromyalgia". Stanford Medicine | Systems Neuroscience and Pain Lab. Retrieved October 4, 2018.
  35. "Revia Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  36. "Revia Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  37. "Naltrexone Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  38. "Naltrexone Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  39. "Seroquel: Drug Uses, Dosage & Side Effects - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  40. 40.040.1 "Quetiapine Uses, Side Effects & Warnings - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  41. "Seroquel Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  42. "Seroquel Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  43. "Quetiapine Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  44. "Quetiapine Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  45. Coe, Holly V; Hong, Irene S (April 17, 2012). "Safety of Low Doses of Quetiapine When Used for Insomnia". Annals of Pharmacotherapy. 46 (5): 718–722. doi:10.1345/aph.1q697. ISSN 1060-0280.
  46. Maglione, Margaret; Maher, Alicia Ruelaz; Hu, Jianhui; Wang, Zhen; Shanman, Roberta; Shekelle, Paul G.; Roth, Beth; Hilton, Lara; Suttorp, Marika J. (2011). Off-Label Use of Atypical Antipsychotics: An Update. AHRQ Comparative Effectiveness Reviews. Rockville (MD): Agency for Healthcare Research and Quality (US). PMID 22132426.
  47. "Ultram Uses, Dosage & Side Effects - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  48. "Ultram Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  49. "Ultram Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  50. "Tramadol Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  51. "Tramadol Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  52. Boostani, Reza; Derakhshan, Siavash (2012). "Tramadol induced seizure: A 3-year study". Caspian Journal of Internal Medicine. 3 (3): 484–487. ISSN 2008-6164. PMC 3755854. PMID 24009919.
  53. "Zanaflex: Uses, Dosage & Side Effects - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  54. "Tizanidine Uses, Dosage, Side Effects - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  55. "Zanaflex Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  56. "Zanaflex Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  57. "Tizanidine Side Effects in Detail - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  58. "Tizanidine Drug Interactions - Drugs.com". Drugs.com. Retrieved August 21, 2018.
  59. Ostalecki, Sharon; Tamler, Martin S. (May 5, 2009). 100 Questions & Answers About Fibromyalgia. Jones & Bartlett Publishers. ISBN 978-0-7637-8708-0.
  60. "A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia - ClinicalTrials.gov". Retrieved August 9, 2018.
  61. Henriques, Carolina (March 27, 2017). "Intec Pharma Launches Phase 1 Trial of Cannabinoid-based Therapy for Fibromyalgia, Lower Back Pain". Fibromyalgia News Today. Retrieved August 9, 2017.
  62. 62.062.1 Johnson, Cort (October 17, 2016). "The Pridgen Revolution? Dr. Pridgen on Bringing His Antiviral Approach to Fibromyalgia To Market - Simmaron Research". Simmaron Research. Retrieved August 9, 2018.
  63. 63.063.1 Moore, Charles (February 2, 2016). "Novel Fibromyalgia Treatment Granted FDA Fast Track Designation - Fibromyalgia News Today". Fibromyalgia News Today. Retrieved August 9, 2018.
  64. 64.064.1 Johnson, Cort (March 26, 2017). "Through the "Valley of Death": Dr. Pridgen, Fibromyalgia and the Looming Trials - Simmaron Research". Simmaron Research. Retrieved August 9, 2018.
  65. 65.065.1 Pridgen, William L; Duffy, Carol; Gendreau, Judy F; Gendreau, R Michael (February 22, 2017). "A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia". Journal of Pain Research. 10: 451–460. doi:10.2147/JPR.S127288. ISSN 1178-7090. PMID 28260944.
  66. Gregory Burch, Donna (September 10, 2016). "Potential Fibromyalgia Treatment is Put on Hold". National Pain Report. Retrieved August 9, 2018.
  67. 67.067.1 Johnson, Cort (July 8, 2017). "The Big Hurt: Second Major Fibromyalgia Drug in a Year Fails - Health Rising". Health Rising. Retrieved August 9, 2018.
  68. Gregory Burch, Donna (August 14, 2017). "Century-old Vaccine Gives New Hope to Fibromyalgia Community - Prohealth". Prohealth. Retrieved August 9, 2018.

adverse reaction Any unintended or unwanted response to a treatment, whether in a clinical trial or licensed treatment. May be minor or serious.

adverse reaction Any unintended or unwanted response to a treatment, whether in a clinical trial or licensed treatment. May be minor or serious.

phase one A drug trial involving only a small group of humans, often healthy volunteers, to assess drug safety and side effects. Typically 20-80 participants, often using a comparison group.

phase three Last phase of clinical trials before a drug can be approved for public use. Whereas Phase one assesses basic safety, and Phase two assesses basic efficacy, Phase three uses many trial participants to fully assess both safety and efficacy, and overall benefit/risk.

double blinded trial A clinical trial is double blinded if neither the participants nor the researchers know which treatment group they are allocated to until after the results are interpreted. This reduces bias. (Learn more: www.nottingham.ac.uk)

phase three Last phase of clinical trials before a drug can be approved for public use. Whereas Phase one assesses basic safety, and Phase two assesses basic efficacy, Phase three uses many trial participants to fully assess both safety and efficacy, and overall benefit/risk.

Agency for Healthcare Research and Quality (AHRQ) - Agency for Healthcare Research and Quality is a United States government agency under the U.S. Department of Health and Human Services. Their mission is "to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable. A representative of the Agency for Healthcare Research and Quality sat on the (now disbanded) CFSAC committee as an Ex Officio Member.

The information provided at this site is not intended to diagnose or treat any illness.
From MEpedia, a crowd-sourced encyclopedia of ME and CFS science and history.