Thursday, 27 November 2014

Cut The Costs Of Neuropathy Medications

Today's post from (see link below) puts forward the premise that if all drugs used to treat neuropathy symptoms work much the same, doctors should prescribe the cheapest first to help save money. It's claimed that all neuropathy drugs will bring relief, which this blog seriously doubts and the article's aim seems more about bringing down costs than effectively treating the patient. It may be true that most neuropathy drugs work equally well but that often means, they don't work well at all - just equally! Apart from the issue of side effects with older drugs, everybody reacts differently and individually to particular treatments. It's not for nothing that there is a treatment cascade of drugs for nerve damage symptoms and that most people work their way through 5 or 6 of them before getting any relief and the reason for that is that they are just not that effective in suppressing nerve pain. If doctors are encouraged to always go for the cheaper option, patients could well have problems for longer and face rejection for better-directed but more expensive options. Cutting costs is a world wide trend at the moment and that may be necessary but then governments need to exert pressure on drug companies to lower their prices, reduce their profits and put the patient first. Cost should never be an issue when treating a serious medical condition.

Cost and effect: Cheaper remedies should rule for diabetes nerve pain, U-M experts say
Brian Callaghan, M.D. Eva Feldman, M.D., Ph.D ANN ARBOR, Mich. 

 Since new analysis of current evidence finds expensive and cheaper drugs both work well, doctors should consider costs until more studies are done

— Millions of people with diabetes take medicine to ease the shooting, burning nerve pain that their disease can cause. And new research suggests that no matter which medicine their doctor prescribes, they’ll get relief.

If all treatments for the condition provide roughly the same relief, doctors should start by prescribing lower-cost ones, the U-M experts say.

But some of those medicines cost nearly 10 times as much as others, apparently with no major differences in how well they ease pain, say a pair of University of Michigan Medical School experts in a new commentary in the Annals of Internal Medicine.

That makes cost -- not effect -- a crucial factor in deciding which medicine to choose for diabetic neuropathy, or diabetes nerve pain, the U-M researchers say.

Their commentary accompanies a paper from Mayo Clinic researchers and their colleagues, who analyzed a wide range of data from clinical trials of different treatments for painful diabetic neuropathy. The Mayo-led team concluded that several options appear to work well, though they need to be compared head-to-head to tell for sure which is best.

Until new studies can make those head-to-head comparisons, say the U-M experts, doctors should consider the cost of the drug, and any other conditions a patient has, when deciding what to prescribe.

Brian Callaghan, M.D., the article’s first author, says the new Mayo study, national guidelines and other efforts have focused on how well different treatments work against diabetic nerve pain. Half of all people with diabetes develop neuropathy sometime during their experience with the disease, and it can keep patients from exercising or walking. Neuropathy plays a role in many diabetes complications.

But cost hasn’t figured into these studies, he says. That’s why he and fellow U-M neurologist Eva Feldman, M.D., Ph.D., decided to look at the dollars side of diabetic neuropathy for their article.

“These treatments all work about the same, but what’s different is their side effects and cost. The older medications are an order of magnitude cheaper, about $15 to $20 a month, compared with the newer ones at nearly $200 per month,” he says. “Patients are on these medications for many years, and it really starts to add up. Given that the effects of the medications are similar, why should we start patients on the expensive drugs until we’ve determined whether or not they respond to the less-expensive ones?”

The newer drugs, of course, have marketing campaigns behind them – and in the case of diabetic neuropathy, their manufacturers may have sought and received specific approval for diabetic neuropathy from the Food and Drug Administration.

The newer drugs have earned the highest level of recommendation in national treatment guidelines, which requires that at least 80 percent of people taking part in a clinical trial complete it in order for the study to be considered for high-level guideline approval. This helps create an artificial appearance that the newer drug is the better choice, says Callaghan.

But in fact, the trials of other medications for diabetic neuropathy had 70 percent or more completion rates, he says – not an appreciable difference.

And even though older generic drugs without a specific indication for diabetes pain must be prescribed “off label” by doctors, the evidence that they work is powerful – including the evidence from the new meta-analysis by the Mayo-led team.

Callaghan, who sees diabetic neuropathy patients at the U-M Health System, says he prescribes generic drugs, gabapentin or one of the tricyclic antidepressants, routinely as the first option for new pain.

The authors looked at the cost of one month of the typical starting dose for each of these medications. According to, pregabalin is the most expensive at $189.98 per month, followed by duloxetine at $170.99 per month. Although venlafaxine is generic, its cost remains high at $119.98 per month. In contrast, gabapentin comes in at $18.99 per month, amitriptyline at $12.99 per month, and nortriptyline at $19.99 per month. A topical cream of capsaicin, available over the counter without a prescription, costs the least: $13.99 per month.

“The Mayo study supports other systematic reviews on this issue,” he says. “We hope that adding in the cost consideration will be useful to neurologists and primary care physicians alike, since we all treat patients with painful diabetic neuropathy.”

Callaghan, an assistant professor in the Department of Neurology, is also a member of the U-M Institute for Healthcare Policy and Innovation. Feldman is the Russell DeJong Professor of neurology and director of the A. Alfred Taubman Medical Research Institute.

Reference: Annals of Internal Medicine: Mayo study: doi:10.7326/M14-0511 U-M commentary: doi:10.7326/M14-2157

Wednesday, 26 November 2014

Hysingla: A New Extended Release, Abuse-Deterrent Opioid For Chronic Pain

Today's post from (see link below) is actually an advertisement from a drug company for one of their latest products. However, in this case, it may be a very helpful one for people suffering acute neuropathic pain. It's called Hysingla ER and is an extended-release opioid designed for exactly the sort of chronic pain that many neuropathy patients suffer. With all the hiatus at the moment (especially in the States) about opioid abuse, it makes a change to hear good news for once. This whole article won't be too much different to the instruction pamphlet you will get in every box and as usual, potential side effects are pretty terrifying but we all know by now, that companies have to cover everything to cover themselves in courts of law. Hysingla should be available on your doctors' prescription pads in 2015 and may be a suitable alternative to what you already take, or a good product if your pain has become so severe that you need opioid help to suppress it. It is FDA approved, which is always a good sign but remember, this applies to the USA; it may take some time before it's available in your country. As always, discuss it with your doctor.

Purdue Pharma L.P. Receives FDA Approval for HysinglaTM ER (hydrocodone bitartrate) Extended-Release Tablets CII, A Once-Daily Opioid Analgesic Formulated with Abuse-Deterrent Properties 
Stamford, Conn. – November 20, 2014

 – Purdue Pharma L.P. announced that the U.S. Food and Drug Administration (FDA) approved Hysingla ER (hydrocodone bitartrate) extended-release tablets CII, a once-daily, single-entity medication formulated using Purdue’s proprietary extended-release solid oral platform, RESISTEC™. It is the first and only hydrocodone product to be recognized by the FDA as having abuse-deterrent properties that are expected to deter misuse and abuse via chewing, snorting and injection. However, abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible.

Hysingla ER does not contain acetaminophen, the overuse of which has been reported to be a leading cause of acute liver failure in the United States.2,3 Prescription products containing hydrocodone and acetaminophen are both the most prescribed and among the most widely abused (nonmedical use) medications in the United States.4,5

“The burden of chronic pain and the abuse of prescription medications are both pressing societal problems,” said Charles E. Argoff, MD, Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Center at Albany Medical Center in New York. “Opioids are an essential tool in our arsenal of medical treatments options, so greater availability and use of opioid analgesics with abuse-deterrent properties has the potential to help alleviate suffering among people with chronic pain while reducing the abuse of these medications. Furthermore, this product gives treatment providers the option to use hydrocodone without acetaminophen if they are concerned that their patients may be taking too much acetaminophen on a daily basis.”

“We are proud to offer healthcare professionals and chronic pain patients another treatment option,” said Mark Timney, CEO of Purdue Pharma L.P. “Hysingla ER is the third product in our pain management portfolio to receive an FDA label describing its abuse-deterrent characteristics. These innovations are an important step forward in helping meet patients’ needs while also working to deter misuse and abuse.”

Purdue expects to launch Hysingla ER in the United States in early 2015 in dosage strengths of 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg to be taken once every 24 hours.

Hysingla ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has the following Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, Hysingla ER should be reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hysingla ER is not indicated as an as-needed analgesic. Hysingla ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, known or suspected paralytic ileus and gastrointestinal obstruction, and hypersensitivity to any component of Hysingla ER or the active ingredient, hydrocodone bitartrate.

Please see the Boxed Warning, Warnings and Precautions, and Adverse Reactions information below.

Abuse-Deterrence Testing and Labeling

Purdue conducted laboratory manipulation and extraction studies, and clinical abuse potential studies with Hysingla ER, in accordance with the FDA’s 2013 Draft Guidance on Abuse‐Deterrent Opioids: Evaluation and Labeling. Based on the results of these studies, Hysingla ER is recognized by the FDA as having abuse-deterrent properties that are expected to deter misuse and abuse via chewing, snorting and injection, resulting in Tier 1 and 3 abuse-deterrence labeling. However, abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible. The methodology and results of these studies are summarized in section 9.2 of the product’s label.1 Additional data, including epidemiological data, when available, may provide further information on the impact of Hysingla ER on the abuse liability of the drug. Accordingly, section 9.2 may be updated in the future as appropriate.

Tier 1 labeling means that a product is formulated with physico-chemical barriers to abuse. To gain Tier 1 labeling, data from laboratory manipulation and extraction studies that assess how the abuse-deterrent properties of a formulation can be defeated or compromised are provided to the FDA. Tier 3 labeling means that the product is expected to result in a meaningful reduction in abuse. To gain Tier 3 labeling, data from clinical abuse potential studies are provided that assess the impact of a formulation’s abuse-deterrent properties on measures that predict how probable it is that the formulation will be attractive to, or “liked” by, abusers. For Tier 4 labeling, the product must demonstrate reduced abuse in the community.6 Purdue will conduct post-marketing surveillance studies to assess this impact of the drug on reducing abuse and diversion in a real-world setting.


RESISTEC™ is Purdue Pharma’s proprietary extended-release solid oral dosage formulation platform. RESISTEC uses a unique combination of polymer and processing that confers tablet hardness and imparts viscosity when dissolved in aqueous solutions.7

About Acetaminophen Toxicity
The use of products containing acetaminophen in high doses over a long period of time can cause severe liver injury, with reports of up to 63 percent of unintentional acetaminophen overdoses associated with the use of opioid-acetaminophen combination products.2,3 In January 2014, the FDA issued a statement that combination prescription pain relievers that contain more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit should no longer be prescribed or dispensed because of a risk of liver damage if taken in doses exceeding the maximum recommended dose.8 According to the FDA statement, cases of severe liver injury have been reported in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took two or more acetaminophen-containing products simultaneously, or combined alcohol with acetaminophen.8

The Full Prescribing Information for Hysingla ER contains the following Boxed Warning:


Addiction, Abuse, and Misuse
HYSINGLA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing HYSINGLA ER, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)].

Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of HYSINGLA ER. Monitor for respiratory depression, especially during initiation of HYSINGLA ER or following a dose increase. Instruct patients to swallow HYSINGLA ER tablets whole; crushing, chewing, or dissolving HYSINGLA ER tablets can cause rapid release and absorption of a potentially fatal dose of [see Warnings and Precautions (5.2)].

Accidental Ingestion
Accidental ingestion of even one dose of HYSINGLA ER, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome
Prolonged use of HYSINGLA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].

Cytochrome P450 3A4 Interaction
The concomitant use of HYSINGLA ER with all cytochrome P450 CYP3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients receiving HYSINGLA ER and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.11) and Clinical Pharmacology (12.3)].


Addiction, Abuse, and Misuse

Hysingla ER contains hydrocodone, a Schedule II controlled substance. Hysingla ER exposes users to the risks of opioid addiction, abuse, and misuse. As extended-release products such as Hysingla ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present. Addiction can occur at recommended doses and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Hysingla ER, and monitor all patients during therapy for the development of these behaviors or conditions. Abuse or misuse of Hysingla ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the hydrocodone and can result in overdose and death.

Life‐Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression has been reported with modified-release opioids, even when used as recommended, and if not immediately recognized and treated, may lead to respiratory arrest and death. The risk of respiratory depression is greatest during the initiation of therapy or following a dose increase; therefore, closely monitor patients for respiratory depression. Proper dosing and titration of Hysingla ER are essential. Overestimating the Hysingla ER dose when converting patients from another opioid product can result in fatal overdose with the first dose. Accidental ingestion of even one dose of Hysingla ER, especially by children, can result in respiratory depression and death due to an overdose of hydrocodone.

Neonatal Opioid Withdrawal Syndrome
Prolonged use of Hysingla ER during pregnancy can result in neonatal opioid withdrawal syndrome which may be life-threatening to the neonate if not recognized and treated, and requires management according to protocols developed by neonatology experts.

Interactions with Central Nervous System Depressants

Hypotension, profound sedation, coma, respiratory depression, or death may result if Hysingla ER is used concomitantly with other CNS depressants, including alcohol or illicit drugs that can cause CNS depression. Start with a lower Hysingla ER dose than usual (i.e., 20-30% less), monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant.

Use in Elderly, Cachectic, and Debilitated Patients and Patients with Chronic Pulmonary Disease
Closely monitor elderly, cachectic, and debilitated patients, and patients with chronic obstructive pulmonary disease because of the increased risk of life-threatening respiratory depression. Consider the use of alternative non-opioid analgesics in patients with chronic obstructive pulmonary disease if possible.

Use in Patients with Head Injury and Increased Intracranial Pressure
Monitor patients closely who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or impaired consciousness). Opioids may obscure the clinical course in a patient with a head injury. Avoid the use of Hysingla ER in patients with impaired consciousness or coma.

Hypotensive Effect
Hysingla ER may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. Monitor patients during dose initiation or titration. In patients with circulatory shock, Hysingla ER may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of Hysingla ER in patients with circulatory shock.

Gastrointestinal Obstruction, Dysphagia, and Choking

Use caution when prescribing Hysingla ER for patients who have difficulty swallowing, or have underlying gastrointestinal disorders that may predispose them to obstruction, dysphagia, or choking. Consider use of an alternative analgesic in these patients.

Decreased Bowel Motility
Hysingla ER is contraindicated in patients with gastrointestinal obstruction, including paralytic ileus. Monitor for decreased bowel motility in post-operative patients receiving opioids. The administration of Hysingla ER may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Hydrocodone may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis.

Cytochrome P450 CYP3A4 Inhibitors and Inducers
Concomitant use of CYP3A4 inhibitors may prolong opioid effects. Use with CYP3A4 inducers may cause lack of efficacy or development of withdrawal symptoms. If co-administration is necessary, evaluate patients frequently and consider dose adjustments until stable drug effects are achieved.

Driving and Operating Machinery

Hysingla ER may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

Interaction with Mixed Agonist/Antagonist Opioid Analgesics
Avoid the use of mixed agonist/antagonist analgesics in patients who have received or are receiving Hysingla ER, as they may reduce the analgesic effect and/or precipitate withdrawal.

QTc Interval Prolongation

QTc prolongation has been observed following daily doses of 160 mg of Hysingla ER. Avoid use in patients with congenital QTc syndrome. This observation should be considered in making clinical decisions regarding patient monitoring when prescribing Hysingla ER in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or who are taking medications that are known to prolong QTc interval. In patients who develop QTc prolongation, consider reducing the dose.


Most common treatment-emergent adverse reactions (≥5%) reported by patients treated with Hysingla ER in the clinical trials were constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence.

The Full Prescribing Information for Hysingla ER, including the Boxed Warning and Medication Guide is available at

About Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on chronic pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at


James Heins
Senior Director, Public Affairs
office: 203-588-8069
mobile: 203-856-2121

Bob Josephson
Associate Director, Media Relations
office: 203-588-7114
mobile: 203-914-7741

1 Full Prescribing Information for HysinglaTM ER (hydrocodone bitartrate) Extended-Release Tablets CII
2 Larson et al. Acetaminophen-Induced Acute Liver Failure: Results of a United States Multicenter, Prospective Study. Hepatology. 2005; 42(6): 1364-1372.
3 Michna, E, Duh, MS, Korves, C, Dahl, JL. Removal of opioid/acetaminophen combination prescription pain medications: assessing the evidence for hepatotoxicity and consequences of removal of these medications. Pain Medicine. 2010; 11: 369-378.
4 IMS Health NPA, based on TRx, August 2014. Accessed Oct. 20, 2014.
5 2013 National Survey on Drug Use and Health, Table 1.89A. Substance Abuse and Mental Health Services Administration. Accessed Oct. 20 2014.
6 Guidance for Industry: Abuse-Deterrent Opioids- Evaluation and Labeling: Draft Guidance. US Food & Drug Administration. Accessed Oct. 20, 2014.
7 Data on File, Purdue Pharma L.P.
8 Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement – Recommendation to Discontinue Prescribing and Dispensing. U.S. Food & Drug Administration. Accessed Oct. 20, 2014.

Tuesday, 25 November 2014

Can Lasers Possibly Help Reduce Neuropathy Problems?

Today's post from (see link below) looks at laser therapy for neuropathic problems. The problem is that this article doesn't explain how laser therapy works, or the science behind it; it just states that many cases of neuropathy can be helped by using directed lasers. If you're interested in the possibilities, it would be advisable to talk it over carefully with your doctor or specialist and find out exactly what's involved. it's true that lasers are being used as surgical tools but how this can help with nerve damage is unclear.

Laser Neuropathy Treatment: How Does It Help?
Posted by Editor on November 17, 2014

Lasers are no longer the giant, destructive beams that were featured in sci-fi movies of the past. Today, laser neuropathy treatment uses low-level focused lasers with healing powers.

Lasers used to be the stuff of science fiction, but today they seem to be everywhere—from the checkout station at your local library to the self-scan at the grocery store. Of course, lasers have also been in use as a surgical tool for many years now.

These days, the use of Low Level Laser Therapy, or LLLT, and Light Emitting Diodes (LED) is commonplace, with much continuing research that shows their effectiveness as healing modalities for neuropathic pain and discomfort.

The fact is, many cases of peripheral neuropathy can be significantly improved with the use of laser neuropathy treatment. Laser treatment can reduce symptoms in chronic pain and even for conditions like disc degeneration and spinal stenosis. What’s more, the use of lasers can also help to stimulate nerves in order to speed up the body’s natural healing process.

You don’t need to understand the actual science behind how lasers work, which can be pretty challenging for the layperson to grasp. But the user experience of laser neuropathy treatment is simple. A laser is a painless and highly focused light beam, which is carefully directed at a specific part of your body for short amounts of time. The time duration and laser power is based on research about the effects of laser treatment on certain body tissues.

Laser neuropathy treatment isn’t an immediate fix for your chronic pain or discomfort. It does take several treatments for an effect to be noticed. However, many patients see a significant positive change within about 12 treatments.

Monday, 24 November 2014

Colo-Rectal Cancer And Neuropathy (Vid)

Today's YouTube video, produced by : Stone Lyons Media,  looks at how chemotherapy drugs can cause neuropathy. In this case, it's produced by the colo-rectal cancer association but can apply to all forms of cancer treatment, depending on the chemo drug used. The neuropathy can be temporary or permanent but either way is a very unpleasant side effect of cancer treatment. Unfortunately, in many cases, it's the lesser of two evils - the cancer has to be treated but neuropathy may result. The advice may seem somewhat simplistic and further medication may be needed to keep the nerve damage symptoms under control but it's certainly worth a view if you are undergoing chemotherapy.

Peripheral Neuropathy & Colorectal Cancer (Chemotherapy)

<a href="/channel/UCeNy8LO21qQ0ANPJHVK_p5Q" class=" yt-uix-sessionlink     spf-link  g-hovercard" data-ytid="UCeNy8LO21qQ0ANPJHVK_p5Q" data-name="" data-sessionlink="ei=dpJwVMPxLYnocL_ZgdAH">FightCRC</a>
Eloxatin® (oxaliplatin) can cause two types of neuropathy: acute and chronic. While acute neuropathy can be managed by avoiding cold and certain foods that trigger it, chronic or peripheral neuropathy gets worse as the cumulative dose of oxaliplatin builds. It tends to fade after treatment with the drug ends, but it may take 18 months to 2 years to go away completely. In a few cases it appears to 

be permanent.

Sunday, 23 November 2014

Is Intravenous Immune Globulin The Answer To Neuropathy Problems?

Today's post from (see link below) is a St Louis Post Despatch, letters-to-the-doctor example, which asks the question whether Intravenous immune globulin is the answer to the neuropathy patient's problem. It's a specific question relating to a specific case but if it's  got you curious as to what IVIG is, then you may want to research further to see if it's a possibility for you.

IVIG is primarily for autoimmune neuropathy 
Dr. K Roach November 06, 2014 12:00 am 
Dr. Keith Roach is a physician at Weill Cornell Medical College and New York Presbyterian Hospital.Readers may email questions to or request an order form of available health newsletters at P.O. Box 536475, Orlando, Fla. 32853-6475

Dear Dr. Roach
• My brother has been treated for peripheral neuropathy for the past 10 years. He turns 60 in October. After an MRI found a left parietal tumor, he was seen by a prominent neurosurgeon who felt that the tumor had been there since birth and is not connected to the symptoms of pain and decreased sensation in his feet and hands. He is not diabetic, has no cardiovascular problems and does not use alcohol. Basically, all tests come back normal. For now, they just monitor the tumor.

My brother resisted taking any narcotics until three years ago and is now on a long-acting narcotic twice a day. The physicians seem to think this is a genetic/autoimmune problem, and my brother is less inclined to keep searching for help.

My question is: Would a trial of IVIG infusion therapy be reasonable? I don’t know if his bloodwork supports checking his immune status, but I am not sure that the results necessarily would reflect the problem. I have read of IVIG use for some neuropathies, but before I try to get my brother to see a neurologist again, I would like to know if this is a possible therapy to try. — M.S.

Answer • Peripheral neuropathy is one of the most frequent topics I get questions about, but it is very difficult to answer the questions, because there are many different kinds of peripheral neuropathies (“peripheral” means the part of the nervous system outside the brain and spinal cord, while “neuropathy” simply means that something is wrong with the nerve).

In general, peripheral neuropathies can be broken down into several categories. Diabetes is the most prevalent one I see, but those caused by prolonged alcohol use and HIV are other common types. Some are indeed autoimmune, such as Guillain-Barre. Other toxins besides alcohol, especially chemotherapy, may cause symptoms in the peripheral nerves. There are genetic or hereditary causes that are relatively rare. Other important causes include infection, especially Lyme disease; hypothyroidism; vitamin deficiencies; and amyloidosis. One cause I see rarely is called paraneoplastic, associated with an existing tumor. That is one way the tumor in the parietal area of the brain could possibly cause the neuropathy.

If the underlying condition can be treated, it should be, but it sounds in your brother’s case that despite looking, his doctors haven’t been able to find a cause. About 1/4 of cases of peripheral neuropathy fall into the idiopathic, or unexplained, category. Intravenous immune globulin is used primarily for the autoimmune types of neuropathy. Only his neurologist can say if it’s right for him.

When the underlying condition can’t be treated, then we rely on medications to ease symptoms. While opiates are sometimes needed, most experts try to avoid them, because the body can get used to them over time. Probably the most effective medications for neuropathies are antidepressants (the older tricyclic antidepressants, such as amitriptyline) and seizure medicines, such as gabapentin (Neurontin) and pregabalin (Lyrica). I always recommend physical therapy, because movement prevents weakness and may improve symptoms.

Saturday, 22 November 2014

Fluoroquinolone Antibiotics Should Carry Psychiatric Warnings

Today's interesting post from (see link below) is another strong article about the problems brought about by certain antibiotics - namely fluoroquinolones. This time, it calls for warnings about psychiatric damage as well as nerve damage from these drugs and provides good background information to the argument. Always discuss the dangers with your doctor if he or she wishes to prescribe these for you.

Psychiatric Warning Should Join Antibiotic Peripheral Neuropathy Warnings, According to FDA Citizen Petition  Written by: Irvin Jackson September 22, 2014

Amid mounting concerns about the risk of peripheral neuropathy from antibiotics like Levaquin, Cipro, Avelox and others, a citizen petition has been filed with the FDA calling for a new black box warning for the entire class of medications to alert users to the risk of psychiatric problems, as well as nerve damage.

Dr. Charles Bennett, of the University of South Carolina, submitted a citizen petition to the FDA last week, calling for the entire class of antibiotics known as fluoroquinolones to receive a new boxed warning, which is the strongest warning the agency can require drugs to carry.

According to the petition, consumers should be provided stronger warnings about the potential pyschiatric side effects of Levaquin, Cipro, Avelox and other members of the same class of drugs, which have been linked to problems like hallucinations, paranoia, amnesia, suicidal thoughts and other mental side effects.

Earlier this summer, Dr. Bennett and the Southern Network on Adverse Reactions (SONAR) filed a similar petition calling for a black box warning on mitochondrial toxicity for the antibiotics, which can lead to severe nerve problems, such as peripheral neuropathy and other health problems.

The petitions have been supported and promoted by the Quinolone Vigilance Foundation, an activist group formed of former antibiotics users who suffered severe side effects after taking the drugs. The group announced the latest citizen petition in a press release on September 15.

Dr. Bennett warns that psychiatric adverse events linked to the use of Cipro, Levaquin and similar antibiotics are a major problem. He calls for a black box warning that advises users that the psychiatric side effects could start during treatment, or may not appear until days, weeks or even months after patients have taken the last dose.

“Although there are numerous psychiatric adverse events on the current fluoroquinolone drug labels, they are essentially hidden under the heading, ‘Central nervous System Effects,'” Rachel Brummert, Executive Director of the Quinolone Vigilance Foundation, said in the press release. “Most people would not look under ‘Central nervous System Effects’ to find information about suicide, hallucinations, paranoia, or panic attacks. A specific heading for ‘Psychiatric Adverse Events’ is badly needed.”

Antibiotic Peripheral Neuropathy Risk

The psychiatric concerns come as concerns have continued to increase about the link between fluoroquinolone antibioitics and perhipheral neuropathy, which can cause long-lasting and permanent nerve damage for some users.

Symptoms of peripheral neuropathy from Levaquin, Cipro, Avelox and other related drugs may include pain, burning, tingling, numbness, weakness, and sensitivity to light touches, temperature and motion in the arms and legs.

In August 2013, the FDA issued a drug safety communication warning about the risk of peripheral neuropathy from the antibiotics, suggesting that the problems may surface at any time after using the drugs and may continue for months or years after the medication is discontinued.

The FDA required the drug makers to add new warnings and information to the antibiotic labels, indicating that individuals should seek medical treatment if they experience symptoms of peripheral neuropathy and encouraging doctors to switch patients to another antibiotic from a different class if nerve damage is suspected.

Researchers Back FDA Findings

The peripheral neuropathy warning came as new research appeared to strengthen the connection between Levaquin and similar drugs and nerve damage that could be permanent in some cases.

About two months after the SONAR petition, filed in June, researchers from the University of British Columbia found that new users of oral fluoroquinolones could have twice the risks of suffering peripheral neuropathy as their peers who do not take the drugs.

The findings, published on August 22 in the medical journal Neurology, appeared to support warnings issued by the FDA last year, indicating that all fluoroquionolones may carry a peripheral neuropathy risk.

Dr. Bennett warns that the cause may be mitochondrial toxicity, which has been linked to a number of neurodegenerative diseases, such as Parkinson’s Disease, and ALS.

Fluoroquinolones are among of the most widely used antibiotics in the United States, including Levaquin, Cipro, Avelox, Noroxin, Floxin and Factive. The class has already been linked to a potential risk of tendon ruptures, retinal detachment, and possible kidney problems.

According to the FDA, there are about 23.1 million patients who received a prescription for an oral fluoroquinolone in 2011. Cipro dominated the market, comprising 70% of those prescriptions, followed by Levaquin or a generic equivalent, which was used by 28%. Another 3.8 million patients received injections in 2011, with Levaquin or a generic equivalent making up 63% of those, followed by Cipro at 28%.

A number of former users who have experienced problems with peripheral neuropathy or psychiatric problems after using the antibiotics are now considering Levaquin lawsuits, Cipro lawsuits and Avelox lawsuits against the manufacturers, alleging that insufficient warnings have been provided for consumers and the medical community for years.

Friday, 21 November 2014

Peripheral Neuropathy And Hepatitis

Today's post from (see link below) is a very useful one for people living with hepatitis C, who also suffer neuropathic problems as a result. You won't find too much information on the net about the two diseases together but this article tries to show why neuropathy can be hepatitis (HCV) -related and once again, it's the treatment of the one disease, that may lead to the other occurring. Unfortunately hepatitis C is a serious problem and the numbers are growing. There are new treatments just coming onto the market but it remains a very difficult viral disease to treat and then with neuropathy on top...well you know the rest. The only light point (if you can call it that) is that the treatment for HCV-related neuropathy is much the same as for most other forms of neuropathy - there are no real deviations just because of the cause and neuropathy patients will recognise the recommendations and suggestions shown here.

HCV – Peripheral 

Neuropathy (PN)

Written by: Alan Franciscus, Editor-in-Chief Hepatitis C Support Project


Neuropathy is a medical term for any disease of the nerves. There are
four major forms of neuropathy – polyneuropathy, autonomic neuropathy,
mononeuropathy and the most common form, peripheral polyneuropathy
– more commonly called peripheral neuropathy (PN). Peripheral neuropa
thy damages the nerves in the legs and arms. Usually the first area that
PN affects is the feet and legs before the hands and arms. This fact sheet
will discuss the HCV-related form of peripheral neuropathy including the
cause, symptoms, and treatments.


The exact cause of HCV-related PN is not completely understood, but
there is some speculation that it could be caused by HCV RNA (viral
load) deposits in blood vessels that supply oxygen to the nerves,
HCV infection of the nerves, an inflammation process in the nerves,
and/or an HCV-related immune disorder. In the past it was believed
that only people with cryoglobulinemia developed HCV-related PN
but it has been proven that HCV-related PN can occur even in the
absence of cryoglobulinemia. Studies have found that up to 15.3% of
the HCV population has PN. If HCV is the cause of PN it would make
sense to treat the cause.

Important note:

Everyone with hepatitis C should be evaluated and receive HCV treatment. Current treatment is very expensive, and some insurance companies and Medicaid/Medicare are restricting HCV treatment to people with the most severe HCV disease. One of the conditions that qualify people for HCV treatment are extrahepatic manifestations. Discuss any symptoms with your medical provider and have them recorded in your medical records. If you are not approved
for the drugs to treat hepatitis C, you may qualify for free drugs or co-pay assistance through a pharmaceutical patient assistance program. More information is available at the end of this fact sheet.

Causes and Risk factors for PN include:
Infections such as hepatitis C, Lyme disease, shingles, Epstein-Barr, and HIV
The most common cause of PN is diabetes – it is estimated that 34% of the diabetic population has PN. This compares to a prevalence of 2.4 - 8% in the general population
Chronic alcohol abuse
Vitamin B deficiencies
Various autoimmune diseases such as lupus
and rheumatoid arthritis
Environmental toxins
Medications, such as HIV medications


The most common symptoms of PN are HCV therapy.
Self-Care Tips:

A healthy lifestyle can help manage PN and the symptoms associated with it. These lifestyle modifications include:
– can help to reduce some of the symptoms, increase overall muscle strength,
increase blood circulation, and prevent muscle wasting or atrophy.
– Eat a healthy diet that will improve overall health and which may help with the gastrointestinal symptoms people with PN experience.
– Cigarette smoking constricts the blood vessels that provide oxygen and nutrients to peripheral nerves. Seek professional services to stop smoking.
– Alcohol abuse is a leading cause of PN. Avoid or greatly reduce alcohol use.
– especially to areas that are affected by PN (hands/feet) will stimulate, relax and may lessen some of the pain
Do not put too much pressure on limbs-legs and elbows such as crossing legs for a long period of time.

Foot Care
As discussed earlier PN usually affects the feet and legs first. Because NP can cause loss of sensation to the lower extremities it is very important that people with PN pay special attention to their feet. The loss of sensation caused by PN can lead to unrecognized cuts, blisters and other damage to the feet. If a condition or injury goes unchecked it could lead to infections and ulcerations that may spread to the bone. Severe bone infection can lead to amputation of the infected bone. There are many ways to take care of and protect your
feet. The American Diabetes Association (ADA) recommendations for foot care can be easily adapted to everyone with PN:
Check all the areas of the feet every single day. Look for red spots, cuts, swelling and blisters. If you can not see the bottom of your feet, use a mirror or ask someone to inspect them for you.
Be more active (exercise and stretching).
Wash your feet everyday. Dry them carefully, especially between the toes.
Moisturize your feet daily (but not between the toes).
Never go barefoot – always wear comfortable shoes and socks. This is because people with PN can cut or damage their feet and may not even notice or feel the pain.
Keep toe nails trimmed so that the nails don’t rub or cut nearby toes.
Be careful not to expose your feet to hot and cold temperatures.
Keep the blood circulating throughout the feet. The ADA recommends wiggling your ankles up and down for 5 minutes – two or three times a day. Don’t cross your legs for long periods of time.
Stop smoking cigarettes.
Check with your medical provider about the need for special shoes (orthotics).