Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Postherpetic Neuralgia

The most common adverse reactions associated with the use of NEURONTIN in adults, not seen at an equivalent frequency among placebo-treated patients, were dizziness, somnolence, and peripheral edema.

In the 2 controlled trials in postherpetic neuralgia, 16% of the 336 patients who received NEURONTIN and 9% of the 227 patients who received placebo discontinued treatment because of an adverse reaction. The adverse reactions that most frequently led to withdrawal in NEURONTIN-treated patients were dizziness, somnolence, and nausea.

Following table lists adverse reactions that occurred in at least 1% of NEURONTIN-treated patients with postherpetic neuralgia participating in placebo-controlled trials and that were numerically more frequent in the NEURONTIN group than in the placebo group.

TABLE 3. Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia
NEURONTIN
N=336
%
Placebo
N=227
%
Reported as blurred vision
Body as a Whole
  Asthenia 6 5
  Infection 5 4
  Accidental injury 3 1
Digestive System
  Diarrhea 6 3
  Dry mouth 5 1
  Constipation 4 2
  Nausea 4 3
  Vomiting 3 2
Metabolic and Nutritional Disorders
  Peripheral edema 8 2
  Weight gain 2 0
  Hyperglycemia 1 0
Nervous System
  Dizziness 28 8
  Somnolence 21 5
  Ataxia 3 0
  Abnormal thinking 3 0
  Abnormal gait 2 0
  Incoordination 2 0
Respiratory System
  Pharyngitis 1 0
Special Senses
  Amblyopia 3 1
  Conjunctivitis 1 0
  Diplopia 1 0
  Otitis media 1 0

Other reactions in more than 1% of patients but equally or more frequent in the placebo group included pain, tremor, neuralgia, back pain, dyspepsia, dyspnea, and flu syndrome.

There were no clinically important differences between men and women in the types and incidence of adverse reactions. Because there were few patients whose race was reported as other than white, there are insufficient data to support a statement regarding the distribution of adverse reactions by race.

 

Gabapentin is used to treat Restless Legs Syndrome

Restless legs syndrome (RLS) is a disorder of the part of the nervous system that causes an urge to move the legs. Because it usually interferes with sleep, it also is considered a sleep disorder.

 

Causes of Restless Legs Syndrome

In most cases, doctors do not know the cause of restless legs syndrome; however, they suspect that genes play a role. Nearly half of people with RLS also have a family member with the condition.

Other factors associated with the development or worsening of restless legs syndrome include:

  • Chronic diseases. Certain chronic diseases and medical conditions, including iron deficiency, Parkinson’s disease, kidney failure,diabetes, and peripheral neuropathy often include symptoms of RLS. Treating these conditions often gives some relief from RLS symptoms.
  • Medications. Some types of medications, including antinausea drugs, antipsychotic drugs, some antidepressants, and cold and allergymedications containing sedating antihistamines, may worsen symptoms.
  • Pregnancy. Some women experience RLS during pregnancy, especially in the last trimester. Symptoms usually go away within a month after delivery.

Other factors, including alcohol use and sleep deprivation, may trigger symptoms or make them worse. Improving sleep or eliminating alcohol use in these cases may relieve symptoms.

Treatment for Restless Legs Syndrome

Treatment for RLS is targeted at easing symptoms. In people with mild to moderate restless legs syndrome, lifestyle changes, such as beginning a regular exercise program, establishing regular sleep patterns, and eliminating or decreasing the use of caffeine, alcohol, and tobacco, may be helpful. Treatment of an RLS-associated condition also may provide relief of symptoms.

Other non-drug RLS treatments may include:

Leg massages
Hot baths or heating pads or ice packs applied to the legs
Good sleep habits
A vibrating pad called Relaxis
Medications may be helpful as RLS treatments, but the same drugs are not helpful for everyone. In fact, a drug that relieves symptoms in one person may worsen them in another. In other cases, a drug that works for a while may lose its effectiveness over time.

Drugs used to treat RLS include:

  • Dopaminergic drugs, which act on the neurotransmitter dopamine in the brain.
  • Mirapex, Neupro, and Requip are FDA-approved for treatment of moderate to severe RLS. Others, such as levodopa, may also be prescribed.
  • Benzodiazepines, a class of sedative medications, may be used to help with sleep, but they can cause daytime drowsiness.
  • Narcotic pain relievers may be used for severe pain.
  • Anticonvulsants, or antiseizure drugs, such as Tegretol, Lyrica, Gabapentin ( Neurontin ), and Horizant.

Although there is no cure for restless legs syndrome, current treatments can help control the condition, decrease symptoms, and improve sleep.

Usual Adult Dose for Restless Legs Syndrome

Gabapentin enacarbil available under the trade name Horizant (R):
600 mg orally once daily with food at about 5 PM

Gabapentin is also used for Prevention of Fibromyalgia

Fibromyalgia is a muscular condition that affects many people. It refers to muscle fatigue and pain felt across different muscle groups in the body, not just on isolated areas.  Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues.

The term fibromyalgia directly means pain that is embedded in the tissues of the muscles, specifically the fibrous tissues.  This very acute pain starts from the ligaments, the tendons, and other such connective muscle tissues that are present all over the muscular system of the body.  Researchers believe that fibromyalgia amplifies painful sensations by affecting the way your brain processes pain signals.

Fibromyalgia Symptoms sometimes begin after a physical trauma, surgery, infection or significant psychological stress. In other cases, symptoms gradually accumulate over time with no single triggering event.

Women are more likely to develop fibromyalgia than are men.  Many people who have fibromyalgia also have tension headaches, temporomandibular joint (TMJ) disorders, irritable bowel syndrome, anxiety and depression.

There are however some controversial theories regarding  Fibromyalgia that propose that this condition is a psychosomatic illness, that is, it is a disorder brought about by psychological factors and not necessarily physical factors. This reasoning is mainly brought about by the strong evidence available that relates Fibromyalgia to major depression.

An in-depth review regarding the association of major depression disorders with Fibromyalgia brought out significant similarities between the two in terms of psychological characteristics and neuroendoctrine abnormalities in the patients.

Researchers believe repeated nerve stimulation causes the brains of people with fibromyalgia to change. This change involves an abnormal increase in levels of certain chemicals in the brain that signal pain (neurotransmitters). In addition, the brain’s pain receptors seem to develop a sort of memory of the pain and become more sensitive, meaning they can overreact to pain signals.

Medications designed to treat epilepsy are often useful in reducing certain types of nerve pain. Gabapentin (Neurontin) is sometimes helpful in reducing fibromyalgia symptoms.  Gabapentin is a medicine used to treat pain caused by nerves that are not working properly.   Gabapentin changes the way that the nerves send messages to the brain. It can be taken in a tablet or a liquid, with or without food.  Doses are usually 1200 mg to 2400 mg each day. At the start of treatment low doses are used to minimise side effects, but the dose is usually increased after a few weeks.

At the reviews of gabapentin for fibromyalgia in drugs.com ,  almost 70% Fibromyalgia Patients think Gabapentin can cure their fiobromyalgia disease.  But almost 20% fiobromyalgia Patients think it doesnot work. ( Rating 1 -2 %),  another 15% patients think it do work but the effect is not that good ( Rating 3 – 5 ).

One of the patient said:

“I have had fibro for 7 years, finally have a doctor that prescribed me Gabapentin. It’s amazing I feel like a normal person again. I sleep through the night, with no pain anymore. My anxiety is gone also, which is awesome. I know everyone is different, but it works for me. I have had little to no side effects yet. First few doses was a bit of an air head other than that no complaints. Being able to function pain free and agitation free is a blessing.”

Another Fiobro patient said:

“I had the best results, in relieving the pain, with gabapentin. I was able to work through the other symptoms. The etodolac helped with the inflammation. I was doing well, until the muscle spasms started, again. I suspect the mould allergies exasperated the symptoms. So, cyclobenzeprine was added. I don’t know what happened, but I was jobless, homeless, and very sick by the time a CVS pharmacist recognized the V.A. had put me on another toxic, prescription drug cocktail. When I brought it to the V.A.s attention, as usual, it was ignored. The medications that help, are the ones the V.A. will not prescribe to veterans like myself. They say speak up, if you do, expect to be classified as mentally ill, violent, aggressive, involuntarily committed”

NatalieW555 Said:
“I was suffering from fibromyalgia pain most of my adult life, I’m 52 by the way, not realizing there was this wonderful medication available to me…I started it about 2 years ago and it really makes a HUGE difference in how my body feels. I take 300 mg 3X daily. I hope it never quits working for me…you should give it a try….It has no side effects on me.”

Member Annabqnm Said:

“Pretty much saved my life. 13 years ago fibromyalgia symptoms (severe pain especially legs and shoulders), started. My father was taking high doses of gabapentin for chronic guillaune barre. He urged me to try it–and it was the first real sleep I had in months! My rheumatologist had me on 1600mg. 3x, gradually lowered to 1600 mg. 2x. Studies at Mayo Clinic and Johns Hopkins show very few (and very mild) side effects, even at high doses. The only problem I have is if I forget to take them. Then I get flu like symptoms. I was able to continue my career (elementary school teacher) with no problems. Retired this year age 66 and very active. BTW my memory seems better than most friends my age.”

But 30% Fibro customers think Gabapentin is not effective for their Fibro disease. I looked the reviews they have wrote, I found most of them are just back pain or leg pain but not Fiobromyalgia. But some Fibro patients do think it has some side effects, especially thought problems such as depression.

One of the Fibro patient said:

“I have “fibromyalgia,” severe muscle pain from a twisted spine/congenitally deformed vertebrae. I was getting better with yoga, but hurt my back/rib muscles overdoing. I developed depression on gabapentin after a few weeks. At first it dulled the pain and made me feel lightheaded, and I had memory problems. Then my anxiety increased and the pain continued, and hit a real low. I spent two weeks in a psych ward until a brilliant psych nurse who believed in treating muscle pain. I am now recovering on a mix of robaxin, a muscle relaxer, a low dose of valium for rib spasms, and prozac and remeron (for sleep) and hope to get off all of them once I can exercise again. Similar reaction to Lyrica four years ago.”

Gabapentin is effective for Fibro. But you need consider whether you can endure the side effects of gabapentin. Please check our website for the Gabapentin Side Effects.

The off-lable use of Gabapentin for migraine

Gabapentin is as an anti-epileptic drug and as an analgesic, particularly for pain of the neuropathic or neurogenic type.  When used for controlling epilepsy, it is usually used in conjunction with another anti-epileptic drug.  But Gabapentin is widely used  to treat nerve pain or neuropathic pain than it is to treat epilepsy.

Gabapentin is also sometimes used to relieve the pain of diabetic neuropathy (numbness or tingling due to nerve damage in people who have diabetes), and to treat and prevent hot flashes (sudden strong feelings of heat and sweating) in women who are being treated for breast cancer or who have experienced menopause (”change of life”, the end of monthly menstrual periods). Talk to your doctor about the risks of using this medication for your condition.

It is also widely used to treat Anxiety and Migraine prevention.

One of Gabapentin “off-label” usage is for migraine prevention and treatment, including migraines with or without aura, vestibular migraines. It can reduce the frequency of headaches, pain intensity, and the use of symptomatic medications. Gabapentin is a good preventive therapy for migraines refractory to standard medications.

The chemical structure of gabapentin is related that of gamma-aminobutyric acid (GABA) which is a neurotransmitter in the brain. The exact mechanism as to how gabapentin controls epilepsy and relieves pain is unknown, but it probably acts like the neurotransmitter GABA.

The effective dose of gabapentin varies greatly. Some persons need only 200-300 mg a day whereas others may need 3000 mg or more a day. It may take several weeks to become effective, so it is important to stay on it for an adequate length of time.

The Efficacy of gabapentin in migraine prophylaxis experiment shows  gabapentin is an effective prophylactic agent for patients with migraine.

In the Clinical trials143 patients evaluated gabapentin for migraine prophylaxis.  After 3 months the patients taking gabapentin had a reduction of the migraine frequency by 1.5 migraines per month (or by 35.7%) compared with a reduction of 0.6 migraines per month for the placebo group. Also, gabapentin reduced the headache frequency by 50% or greater in 45% patients compared with only 16% patients on placebo. The most frequently reported adverse events  were asthenia, dizziness, somnolence, and infection.

In Famous medical websites, migraine patients also review the gabapentin as the migraine prevention medicine. They rate Gabapentin 8.1 stars out of ten stars. It is a high mark and means Gabapentin is a very effective medicine for migraine prevention.

I haven’t been taking this medication for long but it’s helped so much. Neuro started me off on 300mg at night and now I’m at 600mg at night. It doesn’t make me sleepy or drowsy. Before starting gabapentin, I was having migraines just about every day. I started having aphasia and vision changes with my migraines, so I decided to take action. I’ve only been on it for almost 2 weeks but I’ve been migraine free and my triggers are no longer triggers at this point, which is fantastic. I should note it has reduced my appetite but this is not a negative thing.” –  Crystaldreams July 25, 2017

This medication is..interesting. I am 20 with what a few doctors think is Fibro and a chronic pain condition but was Rx’d this med by a psych doctor for tension migraines. While it does NOT really help with migraines, it has been making me awfully sleepy and drowsy, and helping with weird aches and pains throughout my body. It can be used as a mood stabilizer and I can see why- because it makes you so drowsy you can’t do or say anything, especially after taking the evening dose! I’ve been afraid to drive any car since starting this. It makes me more drowsy than my anxiety meds which don’t make me drowsy at all! Doctor is raising the dose because since writing that first part- I have become quite used to the med, where my dose does NOT work  – Chelseabergstresser (taken for 1 to 6 months) May 11, 2017

“I have chronic Migraine called Glutamate Storm. First dose of 100mgs made me sleep 36 hours. Before I got the prescription I never slept more than 5 hours per night and often only got 2 hours of sleep per night. But I did not want to take a prescription every day, so I only took it when my ears were ringing really loud and I was sleep deprived. But then I noticed that my chronic cough was always gone the day after taking Gabapentin. So I started taking it every day for that. When I did, my headache and ear ringing got a lot better. I am now taking 400 mgs per day. I had bad breath at first, but it’s gone. Dr. says it might have detoxed something. I am all for that. Better out than in. This drug has helped me a lot. And I am not pro-pharma.” – Gylm April 26, 2017

Gabapentin is Used to Treat Nerve Pain

Gabapentin is used to help control partial seizures (convulsions) in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

Gabapentin is also used to manage a condition called postherpetic neuralgia, which is pain that occurs after shingles.

Gabapentin works in the brain to prevent seizures and relieve pain for certain conditions in the nervous system. It is not used for routine pain caused by minor injuries or arthritis. Gabapentin is an anticonvulsant.

This medicine is available only with your doctor’s prescription.

This product is available in the following dosage forms:

      • Capsule
      • Tablet
      • Solution
      • Suspension

Nerve pain can be a symptom of many different conditions, includingcancer, HIV, diabetes, and shingles.

For some, nerve pain is frustrating; for others, nerve pain is devastating and life-changing.

Whether it feels like burning, pinpricks, or sudden shocks of electricity, nerve pain can disrupt your life at home and at work. It can limit your ability to get around. Over time, it can grind you down. Studies show that people with nerve pain have higher rates of sleep problems,anxiety, and depression.Your nervous system is involved in everything your body does, from regulating your breathing to controlling your muscles and sensing heat and cold.

There are three types of nerves in the body:

  1. Autonomic nerves. These nerves control the involuntary or partially voluntary activities of your body, including heart rate, blood pressure, digestion, and temperature regulation.
  2. Motor nerves. These nerves control your movements and actions by passing information from your brain and spinal cord to your muscles.
  3. Sensory nerves. These nerves relay information from your skin and muscles back to your spinal cord and brain. The information is then processed to let you feel pain and other sensations.

Because nerves are essential to all you do, nerve pain and damage can seriously affect your quality of life.

When you have a serious medical condition such as cancer or HIV, dealing with the additional misery of nerve pain can be especially hard. But there is good news. While nerve pain can’t always be cured, it can be treated — and there are a lot of good options available.

Experts believe that 40 million Americans are living with nerve pain. The impact of nerve pain is tremendous. Both the costs to the healthcare system as well as loss of wages and productivity are staggering.

How Are Nerve Pain and Nerve Damage Treated?

In many instances, nerve damage cannot be cured entirely. But there are various treatments that can reduce your symptoms. Because nerve damage is often progressive, it is important to consult with a doctor when you first notice symptoms. That way you can reduce the likelihood of permanent damage.

Often, the first goal of treatment is to address the underlying condition that’s causing your nerve pain or nerve damage. This may mean:

  • Regulating blood sugar levels for people with diabetes
  • Correcting nutritional deficiencies
  • Changing medications when drugs are causing nerve damage
  • Physical therapy or surgery to address compression or trauma to nerves
  • Medications to treat autoimmune conditions

Additionally, your doctor may prescribe medications aimed at minimizing the nerve pain you are feeling. These may include:

  • Pain relievers
  • Tricyclic antidepressants
  • Certain anti-seizure drugs – Gabapentin

Complementary and alternative approaches may also help alleviate your nerve pain and discomfort. These include:

  • Acupuncture
  • Biofeedback
  • Hypnosis
  • Meditation