Can a Low-Fat Diet Reverse Neuropathic Pain?

By Pat Anson, PNN Editor

Low fat diets are often recommended for people suffering from obesity and cardiovascular disease, but changes in eating habits are rarely recommended for people who live with chronic pain.

That could be changing thanks to a new study by researchers at the University of Texas Health Science Center, who found that diets high in omega-6 fats are strongly associated with inflammation and neuropathic pain. Omega-6 fats are widely found in typical Western diets of fast food, processed snacks, cakes, and fatty or cured meats.

Conversely, researchers say foods containing healthy omega-3 fatty acids – such as fish, flaxseed and walnuts – could reduce or even reverse neuropathic pain associated with diabetes. Their findings were recently published in the journal Nature Metabolism.

Diabetic neuropathy is a progressive and painful disease that causes burning or stinging sensations in the hands and feet. Many drugs used to treat neuropathic pain, such as gabapentin and pregabalin, often don’t work or have unpleasant side effects.

“This paper is a high-profile contribution for a huge unmet translational need as there are no treatments altering the nature of this neurological disease,” said José Cavazos, MD, director of the South Texas Medical Scientist Training Program at UT Health San Antonio.

In experiments on humans and laboratory animals, UT researchers found that mice fed a diet high in omega-6 polyunsaturated fats became hypersensitive to pain, cold and heat stimulation – signs of peripheral nerve damage. Lowering the amount of omega-6 fats and increasing omega-3 fatty acids reduced pain sensitivity in the mice.

The researchers also found that high levels of omega-6 lipids in the skin of patients with Type 2 diabetes were strongly associated with neuropathic pain and the need for analgesic drugs.

“We believe that these data warrant continued investigation of peripheral fatty acid and metabolite levels as potential pain biomarkers. Such biomarkers could provide clinicians with reliable objective endpoints to guide diagnoses as well as decision making on treatment regimens, including therapeutic diets,” wrote lead author Jacob Boyd, MD, UT Health San Antonio.

About 34 million people in the U.S. have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.

A 2015 study found that a vegetarian diet coupled with vitamin B12 supplements significantly reduced pain and improved the quality of life of people with diabetic neuropathy. Participants also had lower blood pressure and cholesterol levels, and lost an average of 14 pounds.

My Cancer Is Back: Facing Surgery With CRPS

By Cynthia Toussaint, PNN Columnist

After hearing the worst words of my life, “Your cancer has grown back,” I felt hopeless and hated the world. Worse, I had to tell my longtime partner and caregiver, John, the grim news. How could we pull up our frayed boot straps again and survive yet another impossible health crisis?

Since getting Complex Regional Pain Syndrome (CRPS) four decades ago, people often use words like “fighter,” “pain warrior” and “super human” to describe me. The most recent catch phrase is, “Cynth, you got this!”

I’ve come to detest this perceived awesomeness. I don’t want to be an uber-person. I never did. I’m tired. I’m so, so tired. And I long for a slice of vanilla-flavored normal.

As the owner of CRPS and 19 comorbidities, I could not afford the diagnosis of triple negative breast cancer, the most aggressive form. But that’s what was delivered, since luck has never been this lady’s lot.

Without consulting me, the universe long ago decided that I’m supposed to slay every dragon while surviving never ending illness and trauma. This latest hell-news has filled me with anger, rage and major depression.

So much so, that for the first time ever, I’m isolating. This social butterfly has returned to her cocoon, unable to feel joy.

I can’t sleep as I’m plagued by night terrors. Each afternoon, my body trembles uncontrollably. Once heavenly activities, like meditation, exercising and eating, are now chores.

John massages my taut muscle tension through the days and nights – and my IBS has gone haywire. My bubbly spirit is absent and what’s left is demoralized.

And not so long ago, I thought I had this thing licked.

Early last year, after six months of weighing my impossible-with-CRPS treatment options, I started aggressive chemotherapy knowing that this regimen could leave me with a life not worth living. The dream was that my pain would stay in check and I’d achieve a Clinical Complete Response (cancer that cannot be seen with imaging). I’m certain chemotherapy almost ended me, as I was left with virtually no immune system. As a bonus, this was during COVID. 

I was coined a “super responder” when I miraculously accomplished a complete response. At that point, the odds were strongly in my favor that the cancer was gone. But the only way to be sure was to do the follow-up standard of care surgery, which I chose to forego because, with CRPS, surgery is, well, not an option.

The doctors were floored by how well I did, and every indicator leaned toward a clean pathology report. I was ready to move on with my life, one that I felt I’d earned by doing everything right (diet, exercise, stress management, good sleep – the whole kit and caboodle!) One doctor commented, “Don’t even look at the survival numbers. They don’t apply to you anymore.”   

True to form, things went as far south as possible. Because I’m one of the unlucky ones who’s cancer stem cells never went away, my malignancy is growing back. This is not a “recurrence,” but a “persistence” because the chemo didn’t hold.

And now that my complete response is gone, I’ll never have my prior odds. John has lamented for years, “You NEVER get a break!” and I’m finally seeing it his way.

For a chance of survival, I must now have – ta daaa!! – surgery. The doctors tell me my best shot is to do a lumpectomy with follow-up radiation or a stand-alone mastectomy.

Tragically, radiation is off the table as it often causes neuropathic pain. In fact, a radiologist who I respect told me flat out, “I can’t ethically do it to you.” And during a recent visit with my surgeon, she strongly advised that, due to CRPS, I’m not a candidate for a mastectomy, let alone reconstructive surgery. Wow.

Finding a New Care Team

Adding insult to injury, out of nowhere, my lead oncologist dropped me! She did so due to questionable guidance (something I can’t detail here) and is fearful of litigation, which doesn’t make it hurt less. This woman had become my hero and I trusted her with my heart and life. Her betrayal has been soul-crushing and created a crisis of faith. I don’t know who or what to believe in anymore.

But through the shadows, I’m quietly planning my next move – and will take on Round Two one slow... step… at… a... time. I’m assembling a new-and-improved care team to up my odds, including an oncologist, acupuncturist, physical therapist, pain specialist and psychologist. I’ve sweetened the pot with an EMDR (an effective technique for trauma release) practitioner who specializes in people with CRPS. Heck, I’ve even lined up the use of a heated pool in these COVID shutdown days.    

I’m going to have a lumpectomy, a word I can still barely say, let alone write. The scariest part is that my surgeon will also remove a possibly involved lymph node in a nerve rich area, ripe for ample, new pain. My new oncologist is concerned that due to a surgery-induced CRPS flare, my arm may freeze up and become a non-functional torture machine.

Even if the surgery mercifully works without condemning me back to bed, this wouldn’t flip me a “get-out-of-jail-free” card. Because I can only do the “minor” surgery without radiation, my odds of a quick recurrence remain high. This means I’ll be on the prowl for some off-the-grid insurance, perhaps low-dose chemo or an immunotherapy clinical trial. But neither can measure up to the standard of care radiation.

God, to be well enough to be sick!         

So, here I am again, looking down the barrel of a gun, knowing it likely has a bullet with my name on it. Like I said, I’m tired and angry. I’m up to my ass with picking the lesser of two evils, and having to crack the code of the near impossible.

Give me a break, already! And I don’t mean this in a small way. I’m shouting out to the big, bad, ice cold universe that I hope, somewhere, somehow, has a heart.

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome (CRPS) and 19 co-morbidities for nearly four decades, and became a cancer survivor in 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.” 

New European Guideline Says Opioids ‘Do Not Work’ for Many Types of Chronic Pain

By Pat Anson, PNN Editor

Calling opioid medication a “two edged sword,” the European Pain Federation (EFIC) has released new guidelines that strongly recommend against using opioids to treat fibromyalgia, low back pain, migraine, irritable bowel syndrome and other types of chronic non-cancer pain.

“The new recommendations advise that opioids should not be prescribed for people with chronic primary pain as they do not work for these patients,” the EFIC said in a statement.

However, the guideline states that low doses of opioids may be suitable for treating “secondary pain syndromes” caused by surgery, trauma, disease or nerve damage, but only after exercise, meditation and other non-pharmacological therapies are tried first.

“Opioids should neither be embraced as a cure‐all nor shunned as universally dangerous and inappropriate for chronic noncancer pain. They should only be used for some selected chronic noncancer pain syndromes if established non‐pharmacological and pharmacological treatment options have failed,” the guideline states. “In this context alone, opioid therapy can be a useful tool in achieving and maintaining an optimal level of pain control in some patients.”

Opioid pain relievers are not as widely used in Europe as they are in the United States or Canada. The EFIC said it was trying to “allay concerns over an opioid crisis” developing in Europe, as it has in North America.       

“As the leading pain science organisation in Europe, it is crucial that EFIC sets the agenda on issues such as opioids, where there are growing societal concerns. These recommendations clarify what role opioids should play in chronic pain management,” EFIC President Brona Fullen said in a statement.

The guideline’s lead author, Professor Winfried Häuser, said he and his colleagues tried to strike a middle ground on the use of opioids.

“The debate on opioid-prescribing for chronic non-cancer pain has become polarized: opioids are either seen as a dangerous risk for all patients, leading to addiction and deaths, or they are promoted as most potent pain killers for any type of pain,” said Häuser, who is an internal medicine specialist in Germany.

“Opioids are still important in the management of chronic non-cancer pain – but only in some selected chronic pain syndromes and only if established non-pharmacological and non-opioids analgesics have failed or are not tolerated.”

PROP Consulted for European Guideline

The guideline was developed by a 17-member task force composed of European experts in pain management, including 9 delegates selected by EFIC’s board “who advocate and who are critical with the use of opioids.” Only one delegate from Pain Alliance Europe represented patients.

The recommendations developed by the task force were reviewed by five outside experts, including Drs. Jane Ballantyne and Mark Sullivan, who belong to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group in the U.S.  Ballantyne is PROP’s President, while Sullivan is a PROP board member. Several changes suggested by the outside experts were adopted.

Coincidentally, Ballantyne, Sullivan and three other PROP board members were involved in the drafting of the opioid guideline released in 2016 by the U.S. Centers for Disease Control and Prevention. That controversial guideline is now being rewritten by the CDC after voluminous complaints from patients and doctors that the recommendations led to forced tapering, withdrawal, uncontrolled pain and suicides.

Sullivan and two other PROP board members were also involved in drafting Canada’s 2017 opioid guideline, which was modeled after the CDC’s and provoked similar complaints from Canadian pain patients.

90 MME Recommended Limit

The CDC and Canadian opioid guidelines appear to have been used as resources by the EFIC task force, which adopted many of the same recommendations, even while acknowledging the low quality of evidence used to support them.   

One recommendation is straight out of the CDC guideline, advising European doctors to “start low and go slow.” Prescribers are urged to start patients on low doses of 50 morphine milligram equivalents (MME) or less a day and to avoid increasing the dosage above 90 MME/day.

One significant difference with the North American guidelines is that the EFIC recommends that opioids not be prescribed for fibromyalgia, migraines and other chronic “primary pain” conditions for which there is no known cause – suggesting those disorders have an emotional or psychological element that will lead to opioid abuse.

“Prescription of high doses of opioids to patients with primary pain syndromes might have been a factor driving the opioid crisis in North America,” the EFIC guideline warns.

“This was further compounded by patient characteristics that included physical and psychological trauma, social disadvantage and hopelessness that served as a trigger for reports of pain intensity prompting prescriptions of more opioids.”

Secondary pain conditions for which opioids “can be considered“ include multiple sclerosis, stroke, restless leg syndrome, Parkinson’s disease, rheumatoid arthritis, phantom limb pain, non-diabetic neuropathy, spinal cord injuries and Complex Regional Pain Syndrome (CRPS). 

Unlike the North American guidelines, the EFIC acknowledges that there are physical and genetic differences between patients. Some patients who are rapid metabolizers “might require higher dosages of opioids than the ones recommended by the guidelines.“

EFIC GRAPHIC

The EFIC also warns that its guideline should not be used to justify abruptly tapering or discontinuing opioids for anyone already prescribed at higher dosages. The recommendations are also not intended for the management of short-term acute pain, sickle cell disease or end-of-life care.

Insurance Claims Show Lyme Disease More Widespread

By Pat Anson, PNN Editor

A new analysis of insurance claims by the Centers for Disease Control and Prevention suggests that Lyme disease may be far more widespread in the United States than current estimates.

CDC researchers looked at data from MarketScan, a large commercial insurance claims database, and found that Lyme disease diagnoses from 2010 to 2018 were six to eight times higher than the number of cases reported to a federal disease surveillance program.

Lyme disease is a bacterial illness spread by ticks. When left untreated, it can lead to chronic disorders such as fatigue, muscle and joint pain, cognitive issues and other symptoms that are often diagnosed as fibromyalgia, neuropathy and autoimmune disorders.

Most reported cases of Lyme disease occur in 14 states in the Northeast, mid-Atlantic and upper Midwest, especially during the summer months when more people spend time outdoors. Recent studies show Lyme is spreading to neighboring states and is no longer just a seasonal disease, possibly do to the effects of climate change.

The CDC analysis of insurance claims filed by nearly 23 million Americans identified over 140,000 people who were diagnosed with Lyme disease during the study period. That works out to a nationwide rate of 73 cases for every 100,000 people, a rate substantially higher than the 9 cases per 100,000 reported by the surveillance program.

“Age and sex distributions among Lyme disease diagnoses in MarketScan were similar to those of cases reported through surveillance, but proportionally more diagnoses occurred outside of peak summer months, among female enrollees, and outside high-incidence states,” wrote lead author Amy Schwartz, an epidemiologist in the CDC’s Bacterial Diseases Branch.

Schwartz and her colleagues say the larger number of Lyme cases reported by MarketScan may be the result of misdiagnoses, but the volume of claims warrant further investigation.

“Although Lyme disease diagnoses identified from claims data are not supported by the robust evidence of infection required for surveillance reporting, they are a consistent indicator of trends in the healthcare system. In addition, the sheer volume of data available through MarketScan provides potential for new insights into the epidemiology of Lyme disease diagnoses in the United States,” they said.

The CDC findings are similar to a 2017 analysis of insurance claims by the non-profit FAIR Health, which found an unexpected surge in Lyme disease cases during the winter and early spring.

Early symptoms of Lyme disease include fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes. A delayed rash often appears at the site of the tick bite. The rash grows in size and sometimes resembles a bulls-eye. Lyme disease is usually treated with antibiotics.

About 30,000 cases of Lyme disease are reported annually by state and local health departments to the surveillance program. The CDC acknowledges, however, that the actual number of cases is probably much higher and that about 300,000 Americans may become infected every year.

Topical Gel Shows Promise as Treatment for Neuropathic Pain

By Pat Anson, PNN Editor

An experimental gel developed to prevent skin damage caused by aging and ultraviolet light is showing promise as a treatment for chronic neuropathic pain, according to research underway in Australia.

The topical gel – known as RM191A – contains a copper-based compound that is absorbed by the skin and prevents the buildup of free radicals that cause skin damage associated with aging and skin cancer.

In a study recently published in the journal Redox Biology, RM191A was found to have potent antioxidant, anti-inflammatory and wound-healing properties in laboratory mice.

The gel is currently being evaluated in 24 patients at a Sydney hospital as a treatment for chronic nerve pain caused by surgery, chemotherapy, trauma and diabetes.  Results are expected later this month.

“Early sample uses of this topical formulation indicated it could be a significant in the management of certain types of chronic nerve pain,” says Llewellyn Casbolt, chief scientist and co-founder of Sydney-based RR MedSciences, which is developing the gel.

“In many ways, scientists see our discovery as a new class of anti-inflammatory that acts by the modulation of free radicals as well as reducing several inflammatory cytokines, providing a drug that can be therapeutically useful where the reduction of inflammation, as well as cellular and tissue healing - indeed pain relief - is also advantageous for a patient.”

The company plans to release an over-the-counter version of its gel in the next 12-18 months as a treatment for skin damage. It will take longer to get regulatory approval for the gel as a treatment for nerve pain and may require a prescription.

RR MedSciences (RRMS) plans to conduct further trials and is seeking additional partners and funding to accelerate the gel’s development.

“The management of pain, often related to conditions of inflammation or trauma that results in nerve or chronic pain is an area of great need.  Advancing the ability for people to modulate their pain, in a safe and effective manner that improves quality of life, is a core objective,” said Helena Libershal Casbolt, CEO and co-founder of RRMS.

A subsidiary of RRMS is currently selling a copper-based body cream called Blue Healer Care as a treatment for damaged skin and for relief from skin irritation and muscle soreness.

Survey Finds Over Half of MS Patients Abused by Caregivers

By Pat Anson, PNN Editor

People with multiple sclerosis already have enough problems living with a progressive disease and sky-high medical bills. But now there’s word that many of them are being abused by their own caregivers.   

Researchers at the University of California, Riverside surveyed 206 patients with advanced MS and found that over half of them were being abused in some way by an unpaid caregiver who was often a member of their own family. The mistreatment ranged from psychological (44%) and financial abuse (25%) to neglect (16.5%) and physical abuse (11%). Over 8 percent of patients said they were abused sexually.   

"We knew we would find some level of abuse and neglect, but we were surprised by how prevalent it is," said Elizabeth Morrison-Banks, MD, a health sciences clinical professor at the UC Riverside School of Medicine, who led the study. "The findings of this study represent a collective cry for help from so many families affected by multiple sclerosis across the United States."

MS is a chronic and disabling autoimmune disease that attacks the body’s central nervous system, causing pain, numbness, difficulty walking, paralysis, loss of vision and fatigue.

"Some people live with MS for many years but with milder symptoms, and they may remain completely self-sufficient and never require a caregiver,” Morrison-Banks explained. “Others are less fortunate and develop neurological disability that can make them vulnerable to abuse and neglect if they are unable to move around independently, take care of their own finances, or get away from the situation when family conflict escalates. These problems are compounded if the person with MS and family lack financial resources."

A recent study found over 75% of American adults with MS face financial hardship that has forced them to cut spending on food, clothing and housing. Many have gone into debt or filed for bankruptcy, and over a third have delayed or stopped filling prescriptions because they can’t afford them. The average cost of disease-modifying MS drugs is about $76,000 a year.

For MS patients who are struggling financially, hiring a professional caregiver is not an option, so many have to rely on family caregivers.

"Some family caregivers are also working full time, caring for children or other family members, and sometimes dealing with health issues of their own," explained Morrison-Banks. "I want to emphasize that the majority of family caregivers do not mistreat those they care for, even in situations that can be very challenging. Nonetheless, it is important to recognize the risk factors for mistreatment of people with disabilities, and do what we can to identify, mitigate, and prevent abuse and neglect."

Other risk factors for mistreatment include MS patients with higher levels of cognitive impairment, caregivers having a mental health problem, alcohol use by the caregiver or patient, and low levels of social support within the family.

"Being a full-time family caregiver for someone with substantial neurological disability often presents significant challenges," Morrison-Banks said. "Many families take these challenges in stride, but others end up in situations of abuse and/or neglect."

The survey findings have been published in the journal Multiple Sclerosis and Related Disorders. The research paper is believed to be the first to document the nature and extent of caregiver mistreatment of MS patients in the United States.

The survey did not include patients who had paid caregivers or trained clinicians. A study of paid caregivers is an important next step for the research team. The National Multiple Sclerosis Society funded the UC Riverside study.

Study Finds Most Drugs Ineffective for Neuropathic Pain

By Pat Anson, PNN Editor

A first of its kind study that compared four medications widely used to treat neuropathy found that all four were usually ineffective in treating pain and many patients stopped taking them due to side effects.    

Over 20 million people in the U.S. suffer from neuropathic pain, a tingling, burning or stinging sensation in the hands and feet caused by nerve damage. Neuropathy is often caused by diabetes, chemotherapy or trauma, but in about 25% of cases the cause is unknown and classified as cryptogenic sensory polyneuropathy (CSPN).

There is little guidance for physicians and patients on what drugs to take for CSPN, so researchers at the University of Missouri School of Medicine conducted a “real world” study in which 402 patients with CSPN took one of the four neuropathy medications.

The four drugs studied were nortriptyline (Aventyl), a tricyclic antidepressant; duloxetine (Cymbalta), a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant; pregabalin (Lyrica), an anti-seizure drug; and mexiletine (Mexitil), an anti-arrhythmic medication used to treat irregular heartbeats.

Nortriptyline, duloxetine and pregabalin are approved by the FDA for treating neuropathy, while mexiletine is used off-label. None of the drugs were originally developed to treat neuropathic pain.

"As the first study of its kind, we compared these four drugs in a real-life setting to provide physicians with a body of evidence to support the effective management of peripheral neuropathy and to support the need for newer and more effective drugs for neuropathic pain," said lead researcher Richard Barohn, MD, executive vice chancellor for health affairs at the University of Missouri.

After 12 weeks of use, any drug that reduced pain for a patient by at least a 50% was considered effective, a recognized industry standard to define therapy success.. Researchers also kept track of patients who stopped taking a drug and dropped out of the study due to adverse effects.

The study findings, published in JAMA Neurology, can best be described as underwhelming. Patients were far more likely to stop taking a drug than they were to stay on a medication that was helping them.    

Of the four drugs, only nortriptyline was an effective pain reliever for at least 25% of patients. It also had the second-lowest drop-out rate (38%), giving it the highest level of overall utility. Duloxetine had the second-highest efficacy rate (23%) and the lowest drop-out rate (37%).

Pregbalin had the lowest efficacy rate (15%) and the second highest drop-out rate (42%), while mexiletine had the highest drop-out rate (58%) and an efficacy rate of 20 percent.

EFFICACY RATE OF NEUROPATHY DRUGS

SOURCE: JAMA NEUROLOGY

"There was no clearly superior performing drug in the study," Barohn said. "However, of the four medications, nortriptyline and duloxetine performed better when efficacy and dropouts were both considered. Therefore, we recommend that either nortriptyline or duloxetine be considered before the other medications we tested."

While nortriptyline had the highest efficacy rate, it also had the highest rate of adverse events, with over half of patients (56%) reporting side effects such as dry mouth, drowsiness, fatigue and bloating.  

Previous studies have found that duloxetine and pregabalin had higher efficacy rates for neuropathic pain, but Barohn and his colleagues say their research more accurately reflects what patients experience in real life and what physicians encounter in their practice.

“Our findings could affect how these 4 drugs are used by all physicians who treat patients with neuropathy. Findings support duloxetine and nortriptyline as better-performing drug choices in this population with neuropathic pain, suggesting that they should be prescribed before pregabalin or mexiletine are considered. However, this study also supports a finding that all 4 drugs helped improve pain in at least some patients, so each could be tried if others failed,” they concluded.     

There are several other drugs used to treat neuropathy, including gabapentin, venlafaxine and sodium channel inhibitors. Barohn says additional comparative studies should be performed on those drugs. His goal is to build effectiveness data on nearly a dozen drugs for CSPN.

Over 75% of MS Patients Face Financial Hardship

By Pat Anson, PNN Editor

Over 75% of American adults with multiple sclerosis face financial toxicity or hardship that has forced them to cut spending on food, clothing and housing. Many have gone into debt or filed for bankruptcy, and over a third have delayed or stopped filling prescriptions because they can’t afford them.

The findings come from a survey of 243 multiple sclerosis (MS) patients conducted by the Harvey L. Neiman Health Policy Institute. The study is the first of its kind to evaluate how financial hardship is forcing MS patients to forego treatment and make drastic changes in their lifestyles and spending.

In recent years, the cost of prescriptions for many disease-modifying MS drugs has nearly tripled to about $76,000 a year. While insurance pays for most of it, many patients are overwhelmed by deductibles and other out-of-pocket expenses. The lifetime cost of treating MS in the United States is estimated at over $4 million per patient.

“Over the last 20 years, higher out-of-pocket costs for advanced imaging tests and increased cost sharing have caused the financial burdens on MS patients to escalate. Among medically bankrupt families, MS is associated with the highest total out of-pocket expenditures exceeding those of cancer patients,” said lead author Gelareh Sadigh, MD, an assistant radiology professor at Emory University School of Medicine.

“Our study results demonstrate the high prevalence of financial toxicity for MS patients and the resulting decisions patients make that impact their health care and lifestyle.”

More Debt, Less Spending

The findings, published in the Multiple Sclerosis Journal, show that over half of MS patients (56%) reported decreases in their income due to disability, unemployment or retirement. To make ends meet, many cut spending on food and clothing (35%) and leisure activities (50%) or withdrew money from their savings (40%) and retirement accounts (15%). Others went into debt by borrowing money (19%) or charging their credit cards (30%).

Over a third of MS patients decided to forego some type of medical care or treatment, such as not filling a prescription (16%), skipping doses (13.5%) or stopped taking medication (13%).

“These data underscore the need for shared decision-making and an awareness of patient financial strain when planning treatment strategies,” said co-author and Neiman Institute researcher Richard Duszak, MD, a professor and vice chair for health policy at Emory University. “In addition to the impact on adherence, financial toxicity was associated with significantly lower physical health-related quality of life, demonstrating the broad consequences of treatment costs for many MS patients.”

MS is a chronic and progressive disease that attacks the body’s central nervous system, causing pain, numbness, difficulty walking, paralysis, loss of vision and fatigue. Disease modifying therapy (DMT) reduces the frequency and severity of MS flare-ups, but many patients can’t afford the drugs.

A 2019 survey by the National Multiple Sclerosis Society found that 40% of MS patients who take a DMT drug altered or stopped taking their medication due to the high cost. According to Healthcare Bluebook, a 30-day supply of a brand name DMT like Gilenya costs about $8,845, or over $106,000 a year.

Criticism of the high cost of MS drugs is growing. Last year when the FDA approved a new MS medication called Vumerity, drug maker Biogen set its wholesale price at $88,000 a year. That brought a rebuke from the National MS Society, which released a statement that accused Biogen of price gouging.

UK Guideline Warns Against Using Opioids and Most Other Drugs for Chronic Pain

By Pat Anson, PNN Editor

The United Kingdom may be on the verge of adopting even more stringent opioid guidelines than the United States and Canada.  

The UK’s National Institute for Health and Care Excellence (NICE) has released a sweeping guideline drafted by an expert committee that recommends opioid medication not be prescribed for chronic primary pain at any dose due to lack of evidence and risk of addiction.

“Based on their experience, the committee agreed that even short-term use of opioids could be harmful for a chronic condition. The lack of evidence for effectiveness of opioids, along with evidence of long-term harm, persuaded the committee to recommend against opioid use for people with chronic primary pain,” the guideline states.

The NICE guideline doesn’t stop there. It recommends against the use of virtually every other medication commonly used to treat chronic pain, including gabapentinoids, benzodiazepines, acetaminophen (paracetamol), non-steroidal anti-inflammatory drugs (NSAIDS), ketamine, corticosteroids, and antipsychotics. According to NICE, these non-opioid pain relievers may be addictive, have risky side effects and do more harm than good.

“The committee agreed that not commenting on these medicines could result in their continued use in practice, which would be inappropriate given the lack of evidence and possible harms, so they recommended against the use of these treatments,” the guideline says.

The guideline is the first by NICE to address “chronic primary pain” — a vague term used to describe pain conditions that last longer than 3 months, and cause significant emotional distress and disability, such as fibromyalgia, Complex Regional Pain Syndrome, chronic musculoskeletal pain and symptoms that “can’t be accounted for by another diagnosis.”

NICE said the new guideline “should be used alongside” existing recommendations it has already issued for headache, low back pain and sciatica, rheumatoid arthritis, osteoarthritis, spondyloarthritis, endometriosis and irritable bowel syndrome.

The draft guideline recommends that people with chronic primary pain get physical therapy, acupuncture, psychological therapy and regular exercise. Several other alternative therapies, including transcutaneous electrical nerve stimulation (TENS) and manual therapies such as chiropractic care, are not recommended due to lack of evidence.

Surprisingly, the only class of medication that was recommended for chronic primary pain is anti-depressants such as duloxetine (Cymbalta) and fluoxetine (Prozac), even though their use would be off-label.

Most Treatments Don’t Work

In short, the NICE guideline states that few treatments work for chronic primary pain and most should be avoided.

“There is no medical intervention, pharmacological or non-pharmacological, that is helpful for more than a minority of people with chronic pain, and benefits of treatments are modest in terms of effect size and duration. Additional morbidity resulting from treatment for chronic pain is not unusual, so it is important to evaluate the treatments we offer for chronic pain, to focus resources appropriately and to minimise harm,” the guideline warns.

The draft guidance is open for public comment until September 14.

The head of a large association of UK primary care physicians said the NICE recommendations are welcome, as long as the alternative therapies are made widely available.

“Most patients in pain do not want to take medication long-term, and GPs do not want this either, but sometimes medication has been the only thing that brings relief. As such these new guidelines, which focus on alternative therapies, have the potential to be beneficial for patients - but they will need to be guaranteed appropriate access to them,” Professor Martin Marshall, Chair of the Royal College of General Practitioners said in a statement.

“We should also be mindful not to disregard some medications completely as a lack of evidence may be due to a lack of high-quality research, particularly for older drugs, such as paracetamol.”

NICE estimates that chronic pain may affect between one-third and one-half of the UK population. Almost half of people with chronic pain have a diagnosis of depression and two-thirds are unable to work because of it.

The guideline emphasizes that physicians communicate and work collaboratively with patients to understand the symptoms and causes of their pain.  

“Understandably, people with chronic pain expect a clear diagnosis and effective treatment. But its complexity and the fact GPs and specialists alike find chronic pain very challenging to manage, means this is often not possible. This mismatch between patient expectations and treatment outcomes can affect the relationship between healthcare professionals and patients, a possible consequence of which is the prescribing of ineffective but harmful drugs,” Nick Kosky, a psychiatrist and chair of the NICE guideline committee said in a statement.

“This guideline, by fostering a clearer understanding of the evidence for the effectiveness of chronic pain treatments, will help to improve the confidence of healthcare professionals in their conversations with patients. In doing so it will help them better manage both their own and their patient’s expectations.” 

The Wisdom of CRPS: Making My Final Cancer Treatment Decision

By Cynthia Toussaint, PNN Columnist

A year ago when I got my triple-negative breast cancer diagnosis, the second dreadful thought that ran through my head – perhaps worse than the Big C – was that for any chance at survival I had to once again enter the horrific world of western medicine, a system that for decades had brought me only misery when it came to Complex Regional Pain Syndrome (CRPS).

After five months of researching and contemplating what might be my most hopeful and least harmful treatment strategy, I began chemotherapy with a healthy level of trepidation. While chemo torture can only be described as indescribable, I was stunned and pleased to do well out of the gates. In fact, my tumor disappeared during week one.

In all, I miraculously completed 17 chemo infusions while escaping lethal complications, only because my integrative doctor, Dr. Malcolm Taw, kept a check on my oncologist’s over-treatment. Let it be known that when some people die from “complications of cancer,” they’re really dying from doctors taking that lethal risk due to money and/or hubris. A personal example is the week my infusion nurse refused to administer chemo because my blood count was so low she was afraid I’d get an infection and die.

My oncologist’s goal for me was 18 infusions, a ridiculously high number that I began questioning when I hit twelve. My hair was already growing back, while my body was rabidly flushing the drugs out of my system (don’t ask).

I couldn’t find anyone, in person or on the internet, who’d done more than 12 infusions. Scarier, an oncologist who filled in one morning shared with me that at no time in his career had he seen someone order so many.

My guess is that because my oncologist and the massive health system she works for are aggressively working to prove this chemo regimen is a keeper, 18 would seal the deal for their final report.   

CYNTHIA TOUSSAINT

I reluctantly marched on with this needless torture for one reason. My oncologist fed me a steady diet of fear, western medicine at its best.

To keep me in line, I dealt with verbal assaults like, “Your cancer’s going to grow right back if you take a week off.” Another was the golden oldie, “I don’t like your questions!” And after the last infusion went south, I was speared with, “All of my other patients want to live.”

The reason I didn’t graduate at the top of my chemo class of one was that, while driving home from number 17, my hands and feet felt like they were bursting into flames while fireworks popped. When John got me upstairs to our condo, he took a picture of the beet-red appendages, my expression frighteningly pale.

After being hideously ill for four days, which is typical as side-effects are cumulative, one afternoon I played the piano for a few minutes and out of nowhere my CRPS, mixed with chemo and my new friend, neuropathy, appeared without mercy in my wrists and hands. As of this writing, five weeks later, I’ve had little let up. While my idiot oncologist never took my CRPS seriously, I’m suffering at a level 9-10 pain and laboring to navigate a world built for people with hands.

So much for number 18, which broke my heart. I’m a goal-oriented gal, and desperately wanted closure for trauma release. At infusion centers, people get to know each other, who lives and who doesn’t, and it’s a big deal when a patient completes their chemo course. The nurses do a hip-hip-hurrah, ring a bell and everyone gets to say goodbye and good luck. I gave it my crazy-strong best, but as usual, CRPS made my decision.

And it would make my next.

Despite not getting the last infusion in, I hit a home run. No, a grand slam. Confirmed with follow-up imaging, I’d achieved a clinical “Complete Response” – the best I could do and hope for. Turns out I’m what they call a “super responder.”

Standard of care dictates that with triple-negative cancer, complete response or not, surgery is mandated (lumpectomy and lymph node removal) to confirm all microscopic malignancies are gone.

This knowing had been looming like a dark cloud since my diagnosis. CRPS and surgery don’t make good bedfellows, as the cutting and tissue extracting tends to fire up nerves that can spark a full-blown CRPS flare. My past has taught me my flares can last a month. Or a lifetime.  

Still deeply influenced by my doctor’s fear-mongering, I kept coming back to surgery despite its risks and my gut telling me to go another way. For once in my life, I wished I’d been well enough to do all the goddamn treatments without having to work around my never-ending pain. Bottom line, I wanted my best shot at living.

But live how? After surgery, would I be left with a life worth living?

The pulsating, burning pain in my hands and wrists provided this answer too. My body told me, unequivocally, that surgery would leave me with the mother-of-all pulsating burning pain. Body-wide and never ending. 

Traumatized that I couldn’t make this big decision, my life-partner, John, reminded me that CRPS has made all of my decisions for me. It didn’t allow me to have a child. I still can’t marry John after 40 years. And it eviscerated my career, one I still yearn for every day. I’m angry that my disease boxes me into corners and knee-caps me at every turn.

Even so, I left fear behind and went toward the light. John and I found three studies, including a meta-analysis, that support de-escalating treatment for triple-negative complete responders. While still early and controversial, these studies show that women who choose active surveillance in lieu of surgery post-chemo live just as long and well -- dare I say even better -- than those who go under the knife.

My integrative doctor, and even my surgeon, are strongly backing my decision – as does my pain doctor who wryly commented, “I don’t see any reason to poke the bear.” 

I’m damn certain that the decision I’ve made to forego surgery will be the standard of care in 15 to 20 years – and that I’m the future. I know deep inside that my CRPS, for all of its hell and fury, is pointing me into a smarter, wiser decision than the one fear would have driven me to. 

This “super responder” is in remission, and moving on…              

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome (CRPS) and 15 co-morbidities for nearly four decades. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.” 

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FDA Approves Capsaicin Patch as Treatment for Diabetic Neuropathy

By Pat Anson, PNN Editor

Millions of patients with diabetic peripheral neuropathy live with burning or stinging pain in their hands and feet. In what could be called a case of fighting fire with fire, the U.S. Food and Drug Administration has approved the first use of a medicated patch made with capsaicin – the spicy substance that makes chili peppers hot – as a treatment for diabetic neuropathy.

The Qutenza skin patch is made by Grünenthal and contains 8% capsaicin, which acts on pain receptors in the skin by desensitizing and numbing nerve endings.

“Pain associated with diabetic neuropathy is an extremely challenging condition to diagnose, treat and manage effectively, which has a significant quality of life impact for many patients,” said David Simpson, MD, a Professor of Neurology at the Icahn School of Medicine. “In addition, patients are dissatisfied with unresolved pain and the side effects associated with current systemic treatments.”

A 2015 study found that Qutenza worked faster than pregabalin (Lyrica) in treating neuropathic pain, providing relief in 7.5 days, compared to an average of 36 days in patients taking pregabalin. Patients who used Qutenza were also more satisfied with their treatment and had fewer side effects.

That same year the European Commission approved Qutenza as a treatment for diabetic neuropathy, but it took another five years for the FDA to give its approval for the same condition. The patch was initially approved by the FDA in 2009 for treating post-herpetic neuralgia, a complication from shingles.

“Painful diabetic peripheral neuropathy has a significant impact on the day-to-day lives of millions of individuals, and we believe Qutenza can be a much-needed non-opioid treatment option for these patients,” Jan Adams, Grünenthal’s Chief Scientific Officer, said in a statement. “This expanded indication of Qutenza in the U.S. is an exciting milestone in our efforts to make Qutenza available to even more patients in need worldwide.”  

A big catch is that the patch shouldn’t be applied at home and should only be used sparingly. According to its warning label, Qutenza should be applied by a doctor or healthcare professional, who should be wearing a face mask and gloves to protect themselves in a well-ventilated area. Up to four patches can be applied on the feet for up to 30 minutes, a procedure that can be repeated every three months. The most common side effects are redness, itching and irritation of the skin where the patch is applied.

Qutenza has gotten mixed reviews from patients, who warned that capsaicin can cause painful burning sensations.

“Qutenza really does work. I did have very intense burning,” a patient posted in a review on Drugs.com. “The pain can be mind blowing but it does subside and a cool fan helps. Don't let your pets near the area as it will burn them. I have had multiple Qutenza and… it lasts up to 3 months plus. Don't apply yourselves. Use a health professional as it does burn.”

“Although I was informed about this treatment and how your body might react to it, my case spiraled out of hands,” another patient wrote. “The medics had to call a team to manage my situation. The pain was so much that without a shred of doubt words simply can not explain.”

Diabetic neuropathy is a progressive and debilitating complication of diabetes that affects more than 5 million Americans. Patients typically experience numbness, tingling or stabbing sensations in their hands and feet. More severe cases can result in foot ulcers, amputations and other complications.

Study Finds Microdosing THC Reduces Pain Levels

By Pat Anson, PNN Editor

Very low doses of inhaled THC – the psychoactive ingredient in cannabis – can significantly reduce pain levels in chronic pain patients, according to a small study conducted in Israel.

The concept of “microdosing” cannabis isn’t new, but this was the first clinical study to demonstrate its effectiveness in temporarily relieving pain. The study was sponsored by Syqe Medical, an Israeli medical technology company that makes an inhaler designed to deliver microdoses of cannabis and other drugs.

The study involved 27 patients living with neuropathy, radiculopathy, phantom limb pain or Complex Regional Pain Syndrome (CRPS), who self-reported pain levels of at least 6 on a zero to 10 pain scale. Participants were randomly assigned to three groups that inhaled either a placebo or two different microdoses of THC.  

The most effective dose to relieve pain was just 500 micrograms of THC, inhaled 3-4 times per day. Participants reported a 2 to 3 point reduction in their pain levels for 150 minutes.  

A typical cannabis patient might consume 150,000 micrograms of THC per day – about 75 times more than the highest dose used in the study. Researchers say their findings, published in the European Journal of Pain, suggest that pain patients can benefit from dramatically lower doses.

"We can conclude from the study results that low doses of cannabis may provide desirable effects while avoiding cognitive debilitations, significantly contributing to daily functioning, quality of life, and safety of the patient,” said lead researcher Elon Eisenberg, PhD, Director of the Multidisciplinary Pain Relief Unit at Rambam Health Care Campus in northern Israel.

“The doses given in this study, being so low, mandate very high precision in the treatment modality. This precision is unique to the Syqe drug delivery technology, enabling cannabis dosing at pharmaceutical standards."

There were side effects from inhaling microdoses of THC. About 20% of patients reported feeling “high” or experienced dizziness, sleepiness, nausea, cough or dry mouth. But researchers said there was “no evidence of consistent impairment” in any of the participants.

The risk of impairment from THC is one reason researchers and cannabis companies have largely focused on the medical benefits of cannabidiol (CBD), a compound also found in marijuana. CBD is not psychoactive, while THC can make people impaired – at least in high doses.

"This study is the first to show that human sensitivity to THC is significantly greater than previously assumed, indicating that if we can treat patients with much higher precision, lower quantities of drug will be needed, resulting in fewer side effects and an overall more effective treatment,” said Perry Davidson, CEO of Syqe Medical.

“The Syqe drug delivery technology is also applicable to opioids and other compounds that, while potentially effective, are notoriously associated with dangerous side effects. The introduction of a tool to prescribe medications at such low doses with such high resolution may allow us to achieve treatment outcomes that previously were not possible."

In addition to cannabis, the company is also exploring the use of its inhaler to deliver other drugs for treating pain, sleep, anxiety and cancer. The Syqe inhaler is sold in Israel by Teva Pharmaceuticals. Approval is also being sought to begin sales in Europe, Canada and Australia. Syqe is planning to submit a medical device application to the Food and Drug Administration in the United States.

Cost of MS Drugs Nearly Tripled

By Pat Anson, PNN Editor

The cost of prescriptions for disease-modifying multiple sclerosis (MS) drugs nearly tripled in the last decade, even with the introduction of cheaper generic versions, according to a new study funded by the National Multiple Sclerosis Society.

Researchers found spending on 15 MS drugs in the Medicaid program increased from $453 million in 2011 to $1.32 billion in 2017.

“Most of these drugs cost more than $70,000 per year on average and costs for these drugs are among the highest drug cost areas for private insurers as well as Medicare and Medicaid,” said Daniel Hartung, PharmD, of Oregon State University in Portland. “Unfortunately for people with MS, the introduction of a generic drug had a minimal effect on prices overall.”

Hartung and his colleagues found that when a generic version of the drug glatiramer acetate (Copaxone) was introduced in 2015, it was only 15 percent cheaper than the brand name drug made by Teva Pharmaceuticals.

Teva also worked to maintain its market share by encouraging doctors and patients to switch from a 20 mg dose of Copaxone to a 40 mg dose, which was not interchangeable with the new generic.

A second company introduced a generic version of glatiramer acetate in October 2017. Only then did the cost start to come down and generic versions started to get a greater share of the MS market.  

“After our study was complete, the company that introduced the second generic drug dropped its costs significantly, making it the lowest cost disease-modifying drug for MS on the market,” Hartung said. “Despite this, there is an urgent need for more robust competition from generics within these MS drugs.”

A similar study published last year found that Medicare paid nearly $76,000 annually per patient for disease modifying therapy (DMT), which reduces the frequency and severity of MS flare-ups. MS is a chronic and progressive disease that attacks the body’s central nervous system, causing pain, numbness, difficulty walking, paralysis, loss of vision, and fatigue.

Many Patients Can’t Afford DMT Meds

A recent survey by the National Multiple Sclerosis Society found that 40% of MS patients who take a DMT drug altered or stopped taking their medication due to the high cost. Only 11% said they could afford the medication without financial assistance.

“People with MS are paying the price, not only financially, but also physically and emotionally,” Bari Talente, executive vice president of advocacy for the National MS Society said in a statement.

“When someone alters or stops the use of their DMT, it can lead to increased symptoms, relapses, stress and anxiety. We need to make these medications affordable and accessible so people already facing a chronic illness don’t have to deal with deciding between buying groceries for their families or paying for their medication.”

The FDA recently approved the first generic versions of Gilenya (fingolimod) for the treatment of relapsing forms of multiple sclerosis (MS). A 30-day supply of brand name Gilenya 0.5mg capsules currently costs about $8,482, according to Healthcare Bluebook, or nearly $102,000 a year.

Few people actually pay the full amount for a DMT drug. About 45% of MS patients do not pay anything out-of-pocket for their DMT. The average annual cost among those who do pay is about $2,300.

Research Explores Cannabis as Treatment for MS, Alzheimer’s and Huntington’s Disease

By Pat Anson, PNN Editor

The University of Alberta is partnering with a Canadian cannabis company in three research projects exploring the use of medical cannabis for the treatment of multiple sclerosis, Alzheimer’s and Huntington’s diseases. 

Atlas Biotechnologies is investing nearly $300,000 over the next two years to fund the studies. Atlas operates a 38,000 square foot cannabis production facility near Edmonton and will supply customized blends of cannabis products to U of A researchers.

“People are touting (cannabis) for all kinds of things, but without solid scientific evidence,” said Ross Tsuyuki, PharmD, chair of the Department of Pharmacology at U of A. “But there likely are benefits for some conditions.”

The most well-known chemical compounds in cannabis are tetrahydrocannabinol (THC) and cannabidiol (CBD), but the plant has hundreds of other active biological chemicals, each with the potential of having therapeutic benefits. The goal of the research is to identify what specific compounds or combinations of compounds are effective.

“We've got to figure out the best combination of those compounds and how they're actually working in people,” Jeffrey Gossain, Atlas’ chief operating officer, told Folio, the University of Alberta's news site.  “A lot of people will tell you, 'My mom had cancer’ or, ‘My friend had an illness, and they took cannabis and it helped.’ But then for other people they don't have as effective results. 

“Part of the problem is that you don't really know what product they took, how they dosed it or the combinations of chemicals in the product that helped. It's not as simple as just saying, ‘The plant's got THC and CBD.’ You've got to get a lot more detailed than that.”

The research will examine whether CBD and other cannabinoids can relieve pain in patients with multiple sclerosis; if cannabis can reduce neuroinflammation and degeneration of the brain caused by Huntington's disease; and if cannabinoids have neuroprotective activity in models of Alzheimer’s disease.

“Alzheimer's disease, chronic pain, multiple sclerosis and Huntington's disease are all devastating conditions that don't have a lot of effective treatments,” said Tsuyuki. “If we find something, even if it works just a little, that could be an enormous advance for patients. But we have to do our homework first, and that is where we're starting.”

In addition to its partnership with the U of A, Atlas is collaborating with Harvard Medical School in developing cannabis products for pain and other neurological conditions.

A recent study found that medical cannabis is mildly effective in relieving pain and other symptoms in patients with multiple sclerosis (MS). Spanish researchers analyzed 17 clinical trials involving different combinations of THC and CBD, and found cannabis had limited effectiveness in relieving pain, muscle spasticity and bladder dysfunction.

MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain.

FDA Warns of Serious Breathing Problems Caused by Gabapentinoids

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning that serious breathing problems can occur in patients who use gabapentin or pregabalin with opioids or other drugs that depress the central nervous system. The elderly and patients with lung problems are at higher risk when they use the drugs, according to an FDA drug safety communication.

The advisory is the latest in a series of warnings about gabapentinoids, a class of nerve medication increasingly prescribed as an alternative to opioid painkillers. There are growing reports of gabapentinoids being abused or raising the risk of overdose and suicide.

“Reports of gabapentinoid abuse alone, and with opioids, have emerged and there are serious consequences of this co-use, including respiratory depression and increased risk of opioid overdose death,” Douglas Throckmorton, MD, deputy director for Regulatory Programs in the FDA’s Center for Drug Evaluation and Research, said in a statement.

“In response to these concerns, we are requiring updates to labeling of gabapentinoids to include new warnings of potential respiratory depressant effects. We are also requiring the drug manufacturers to conduct clinical trials to further evaluate the abuse potential of gabapentinoids, particularly in combination with opioids, with special attention being given to assessing the respiratory depressant effects.”

Gabapentinoid products include gabapentin, which is marketed under the brand name Neurontin, and pregabalin, which is marketed as Lyrica. Generic versions of the drugs are also available.

Gabapentinoids were originally developed to prevent seizures, but their use has tripled over the past 15 years. The drugs are approved to treat a variety of chronic pain conditions, such as fibromyalgia, neuropathy and shingles. They are also widely prescribed off-label.

According to the FDA, over 13 million people filled a prescription for gabapentin in 2016, while over 2 million patients were prescribed pregabalin. Nearly one in five of those patients were also taking opioids.

“Pairing an opioid with any CNS depressant – a gabapentinoid, benzodiazepine, sedating antidepressant, sedating antipsychotic, antihistamine, or other product – will increase the risk of respiratory depression. Shifting treatment from one CNS depressant to another may pose similar risks,” the FDA said.

A Dozen Deaths

The agency said it received 49 case reports of serious breathing problems in patients taking gabapentinoids, including 12 people who died from respiratory depression. It’s advising doctors, caregivers and patients taking gabapentinoids to be alert for signs of confusion, disorientation, dizziness, sleepiness, slow or shallow breathing, unresponsiveness, or bluish-colored lips, fingers and toes.

A 2018 study by Australian researchers found that gabapentinoids often had side effects such as drowsiness, dizziness and nausea. Another study found that combining gabapentin with opioids significantly raises the risk of dying from an overdose. And a recent analysis of calls to U.S. poison control centers found a significant increase in suicide attempts involving gabapentin.

There have also been increasing reports of gabapentin and pregabalin being abused by illicit drug users, who have learned they can use the medications to heighten the high from heroin, marijuana, cocaine and other substances.

A recent study published in JAMA Internal Medicine found little evidence that gabapentinoids should be used off-label to treat pain and said their effectiveness was often exaggerated by prescribing guidelines. The CDC’s 2016 opioid guideline recommends gabapentin and pregabalin dozens of times as alternatives to opioids, without saying a word about their abuse or side effects.

“Our goal in issuing today’s new safety labeling change requirements is to ensure health care professionals and the public understand the risks associated with gabapentinoids when taken with central nervous system depressants like opioids or by patients with underlying respiratory impairment. However, we do not want to unintentionally increase opioid use by turning prescribers away from this class of pain medications,” Throckmorton said.