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Tuum Est: Gabapentin Watch

Who Does, and Doesn’t, Still Recommend Neurontin?

Monitoring the Prescribing Practices for Neurontin

Gabapentin is a purported analgesic manufactured by Pfizer; the brand name is Neurontin. This topic is deserving of analysis, and we do so in our Gabapentin Series, focusing on the Early Clinical Trials and the Phase IV Seeding Trial. Those pages cover a wide range of pain conditions for which Neurontin has been prescribed including neuropathic pain, nociceptive pain, migraine, diabetic neuropathy, and postherpetic neuralgia.

The page you are reading – Gabapentin Watch – reviews the sources which either caution against, or push the prescribing of, Neurontin. Available resources number in the hundreds. To keep this page manageable, we surveyed the top medical journals, major consumer sources, and main Regulatory Agencies of North America.

We further delimit our discussion to neuropathic pain, chosen because it is the umbrella over Reflex Sympathetic Dystrophy (CRPS Type I) – one of the conditions profiled on Tuum Est. We note that the Canadian Pain Society champions patients by taking pain seriously. But the constant lionizing of gabapentin (and antidepressants) for pain sets back the cause of research: the deception delays finding real first-line treatments for neuropathic pain.

Neurontin (generic name gabapentin) no longer enjoys patent protection. That explains why Pfizer brought out a next-generation gabapentinoid called Lyrica (generic name pregabalin) which has nearly identical properties, and nearly identical benefits and harms – but costs more as its patent period has just begun.

Physicians and patients: If you have time to read just one reference, your time would be well spent with the Therapeutics Initiative Letter [75], a practical clinical guide to Gabapentin from the UBC Dept of Anesthesiology, Pharmacology and Therapeutics.

TABLE:  Modern  /  Sources with Up-to-Date Information on Neurontin (Gabapentin)
Status Updated Citation:  Source and Excerpt

Primary
Source

2017

Health Canada Product Monograph: Gabapentin / Gabapentin Risks
Government of Canada

Gabapentin: Full Prescribing Information

Gabapentin is indicated as adjunctive therapy for the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy. Systematic studies in geriatrics (65+ years) have not been conducted. Safety and efficacy in pediatrics (<18 years) has not been established.
(Above is the full Indications list; notably, neuralgia and pain are absent.)

Primary
Source

2017

FDA Medication Guide: Neurontin
U.S. Food and Drug Administration (FDA)

Neurontin: Full Prescribing Information

Neurontin is indicated for: Management of postherpetic neuralgia in adults. Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.

Modern

2017/11

RxList:  Neurontin
WebMD Network

Neurontin: Professional Information

Neurontin is indicated for: Management of postherpetic neuralgia in adults. Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.

Modern

2015/12

American Family Physician 2015; 1(92)
David Garcia, MD

Medicine by the Numbers: Gabapentin for Chronic Neuropathic Pain

The regulatory and research history of gabapentin is important and relevant: it all strongly suggests that the available data on gabapentin cannot be comfortably extrapolated or applied to practice. We rate gabapentin for chronic neuropathic pain at Level Yellow, meaning we believe that a proper answer is not yet available.

Modern

2013/10

Alberta College of Family Physicians (Canada)
Allan, Basset / Update: Lindblad

Gabapentin & Chronic Pain: Missing Evidence and Real Effect?

Clinical Question: What is the evidence to support gabapentin (or pregabalin) in peripheral neuropathic pain? Bottom-line: The apparent benefit was exaggerated by publication and reporting biases. In carefully selected patients, gabapentin may offer moderate or more pain relief for one in every 6-8 patients but causes adverse events in a similar number. There is no trial evidence that pregabalin is superior to gabapentin.

Modern

2009/12

Therapeutics Initiative [75]
UBC Dept of Anesthesiology, Pharmacology and Therapeutics

Gabapentin for Pain: New Evidence from Hidden Data

A gradually broadened category of neuropathic pain became gabapentin's most durable market. Consumption is still rising, costing the B.C. Health Ministry over $30 million in 2009. During recent U.S. litigation, the court ordered access to many unpublished studies on Neurontin, allowing a more accurate appraisal:

  • Misleading promotion pushed gabapentin to blockbuster status; scientific evidence suggests gabapentin has a minor role in pain control.
  • Gabapentin reduces neuropathic pain by less than 1 point on a 0-10 point scale and benefits about 15% of carefully selected patients. A similar proportion of people suffer adverse effects.
  • A test of benefit/harm can be made after 1-2 days at a low dose (100-900 mg/day). Benefit is unlikely to increase with higher doses or longer treatment.
  • Gabapentin has no role in acute nociceptive pain.
  • Benefits and harms of pregabalin are similar to gabapentin, at higher cost.

Modern

2009/11

American RSDHope
Patient Support Group for Reflex Sympathetic Dystrophy

Neurontin: FDA Rejection for Neuropathic Pain

If you were ever placed on Neurontin for CRPS relief, or for any other reason, do a web search to learn about this medicine. For some reason patients are reporting daily doses far above the recommended 1800 mg/day. Neurontin can be very useful for those with seizures, but it needs to be used and marketed appropriately. Consult the court ruling Kaiser v. Pfizer.

Modern

2004/05

British Medical Journal 2004; 328
Interview: Microbiologist Dr. David Franklin

Pfizer Pleads Guilty, But Drug Sales Continue to Soar

Pfizer's promotional efforts were profoundly effective. A huge majority of people taking gabapentin are now taking it for the wrong reasons.

TABLE:  Mixed Message  /  Sources with Self-Contradictory Advice for Neurontin (Gabapentin)
Status Updated Citation:  Source and Excerpt

Mixed
Message

2107/06

Cochrane Pain, Palliative and Supportive Care Group
Wiffen, Derry, Bell, Rice, Tölle, Phillips and Moore

Gabapentin for Chronic Neuropathic Pain in Adults

Cochrane reviewed 37 Neurontin studies, with 5914 participants in all. High risk of bias arose from small sample sizes, and the way data was handled after patients withdrew. Gabapentin provides good pain relief in postherpetic neuralgia and diabetic neuropathy. Evidence for other types of neuropathic pain is very limited. Over half of those treated will not have worthwhile pain relief but may experience adverse events.

Tuum Est note: Postherpetic neuralgia is a defensible target for gabapentin, but diabetic neuropathy is not: the latter is an off-label use which long ago failed under scrutiny. The statistic over half those treated is unclear: which diseases did those patients have?

Mixed
Message

2017/12

Mayo Clinic Healthy Living
Mayo Foundation for Medical Education and Research

Complex Regional Pain Syndrome

Medications: Sometimes anticonvulsants, such as gabapentin (Gralise, Neurontin), are used to treat pain that originates from a damaged nerve (neuropathic pain).

Tuum Est note: That is out of date. But another Mayo Clinic page Gabapentin (Oral Route) has begun to place restrictions, if vaguely, on the types of pain gabapentin can treat.

TABLE:  Fallacy  /  Sources that Falsify the Evidence for Neurontin (Gabapentin)
Status Updated Citation:  Source and Excerpt

Fallacy

2017/12

Pharmacy Times
Fudin, Donovan, Raouf

Jeffrey Fudin

Jeffrey Fudin, PharmD

Appropriate Gabapentin Dosing for Neuropathic Pain

The therapeutic dose for gabapentin is 1800-3600 mg/day in three divided doses. Studies show that most patients receive a sub-therapeutic dose (usually half the designated dose).

If an analgesic is being used at a suboptimal dose, oftentimes a knee-jerk reaction is to add another analgesic for synergy. This is inappropriate without maximizing the dose of each single agent with careful attention to dose titration.

Gabapentin remains among the most commonly used anticon­vulsants for neuropathic pain. Gabapentin is not a PRNPRN = As needed; as the occasion arises. Regarding prescriptions: Given on patient request, rather than to a set schedule.Latin: Pro re nata medication; it needs to be taken around the clock. Pharmacists can collaborate with prescribers to optimize the use of gabapentin in neuropathic pain.

Tuum Est note: All clinical trials were negative for the primary outcome (pain control). Pfizer then made do with a secondary outcome (improved sleep score) which truly was positive, for gabapentin shows narcosisNarcosis = A state of stupor, drowsiness, or unconsciousness produced by drugs.-potentiating or sedating properties (revealed by the patent). Impact: Patients still lose their lives to pain, just in a different way – patients cannot be productive or do gainful work if they are drowsy or sleep round the clock.

Fallacy

2017/11

MedlinePlus
U.S. National Library of Medicine

Gabapentin

Gabapentin is used to help control certain types of seizures in people who have epilepsy. It is used to relieve the pain of postherpetic neuralgia, and to treat restless legs syndrome. Other uses: Gabapentin is also sometimes prescribed to relieve the pain of diabetic neuropathy, and to treat and prevent hot flashes in women who have breast cancer, or during menopause.

Fallacy

2017/11

Canadian Family Physician 2017; 63
Mu, Weinberg, Moulin, Clarke

Pharmacologic Management of Chronic Neuropathic Pain

Practical summary of the Canadian Pain Society Consensus Statement to guide family physicians. Gabapentinoids (gabapentin and pregabalin) play an important role in first-line management of patients with neuropathic pain. Medications are considered first-line if there is high-quality evidence of efficacy.

Neuropathic Pain: Treatment Algorithm
Treatment Algorithm

Tuum Est challenge: The Canadian Pain Society champions patients by taking pain seriously. But the constant lionizing of gabapentin (and antidepressants) for pain sets back the cause of research: the deception delays finding real alternatives to opioids.

Fallacy

2017/03

World Health Organization (WHO)
21st Expert Committee on the Selection and Use of Essential Medicines

Gabapentin - EML / Essential Medicines Selection

The International Association for the Study of Pain (IASP) applied for inclusion of gabapentin on the WHO Model List of Essential Medicines.

IASP Application to WHO (2016) / Appendix
International Association for the Study of Pain (IASP)

Gabapentin for Neuropathic Pain

We are applying for inclusion of gabapentin as an analgesic agent for management of neuropathic pain (central and peripheral) in adults.

Fallacy

2017/01

Burns &s Trauma 2017; 5(2)
Goh, Chidambaram, Ma

Complex Regional Pain Syndrome: A Recent Update

Medical Management:  Anticonvulsants such as gabapentin are commonly used as part of the pharmacological management of CRPS. Studies investigating the efficacy of gabapentin in CRPS Type I have reported marked improvements in pain reduction and long-term sensory deficits, thereby supporting the utility of this therapy.

Fallacy

2015/11

Drugs.com:  Gabapentin
American Society of Health-System Pharmacists

Gabapentin Monograph for Professionals

Gabapentin is used for management of:

  • Seizure disorder (not qualified by the word epilepsy)
  • Postherpetic neuralgia
  • Diabetic neuropathy
  • Chronic neurogenic pain in a variety of conditions including trigeminal neuralgia, paroxysmal symptoms of Multiple Sclerosis, Complex Regional Pain Syndromes, peripheral neuropathy, and neuropathic pain associated with cancer
  • Restless legs syndrome
  • Hot flashes associated with breast cancer or menopause

Tuum Est note: Drugs.com cites all the old falsified research papers including those by Gorson, Serpell, and Backonja whose negative data, if truthfully analyzed, could be expected to decimate the market for Gabapentin.

Fallacy

2015/02

The Lancet Neurology 2015; 14
International Association for the Study of Pain (IASP)

Pharmacotherapy for Neuropathic Pain in Adults:
A Systematic Review and Meta-Analysis

Trial outcomes were generally modest. Tolerability and safety were higher with topical drugs (eg. lidocaine patches). These findings permit a strong recommendation for use, and proposal as first-line treatment in neuropathic pain for: tricyclic antidepressants, serotonin-noradrenaline reuptake inhibitors, pregabalin, and gabapentin.

Georgena S. Sil
Saskatoon, Canada
Physicist & Technical Writer
Alumnus: University of British Columbia
TuumEstContact@protonmail.com
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Copyright © 2008-2019 Georgena Sil. All Rights Reserved.