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.” 

Virtual Reality Therapy Can Reduce Chronic Pain at Home

By Pat Anson, PNN Editor

Therapeutic virtual reality (VR) can reduce chronic pain, improve mood and help people sleep, according to a small study of 74 patients living with fibromyalgia or chronic lower back pain.

The research, published online in JMIR-FR, is one of the first to look at the effectiveness of VR therapy when self-administered at home by chronic pain patients. It was funded by AppliedVR , a Los Angeles based company that is developing therapeutic VR content to help treat pain, depression, anxiety and other conditions.

“People with chronic pain often have limited access to comprehensive pain care that includes skills-based behavioral medicine. We tested whether VR that was self-administered at home would be an effective therapy for chronic pain,” said Beth Darnall, PhD, a pain psychologist who is AppliedVR’s chief scientific advisor.

“We found high engagement and satisfaction, combined with clinically significant reductions in pain and low levels of adverse effects, support the feasibility and acceptability for at-home, skills-based VR for chronic pain.”

Participants in the study were given VR headsets and instructed to have at least one session daily for 21 days. Half of the patients listened to audio-only programming, while the other half watched “virtual” programs in which they could swim with dolphins, play games or immerse themselves in beautiful scenery.

The programs are designed to help patients learn how to manage their pain and other symptoms by using cognitive behavioral therapy (CBT) to distract them and make their pain seem less important.

A sample of what they saw can be seen in this video:  

At the end of the study, 84 percent of the patients reported they were satisfied with VR therapy, which worked significantly better than the audio-only format in reducing five key pain indicators:

• Pain intensity reduced an average of 30%

• Physical activity improved 37%

• Mood improved 50%

• Sleep improved 40%

• Stress reduced 49%

Previous VR studies have had similar findings, but have largely focused on patients in hospitals and clinical settings. 

“This study is a fundamental step for advancing a clinically proven, noninvasive and safe digital therapeutic like VR for chronic pain, and demonstrates our platform is both viable and efficacious,” said Josh Sackman, co-founder and president of AppliedVR.

“Living with and managing chronic pain daily can be a debilitating and costly challenge, and many patients suffering from it can feel hopeless and desperate for any relief. So, as we engage in and accelerate more in-depth clinical research, we want them to know that we’re committed to making VR a reimbursable standard of care for pain.”

AppliedVR products are being used in hundreds of hospitals, but are currently only available to healthcare providers. The company recently partnered with University of California at San Francisco to study how VR therapy can improve patient care for underserved populations.

AppliedVR is also conducting two clinical trials to see if VR therapy can reduce the use of opioid medication for acute and chronic pain. The National Institute on Drug Abuse recently awarded nearly $3 million in grants to fund the trials.

The company is currently recruiting patients with chronic lower back pain for an 8-week trial of VR therapy. Headsets and other material will be mailed at no cost to participants at their homes. No in-person visits are required.  

Most Patients Say Cannabis Effective for Musculoskeletal Pain

By Pat Anson, PNN Editor

The vast majority of people with musculoskeletal pain who have tried medical cannabis say it is an effective pain reliever and over half believe it works better than other pain medications, according to a new study released by the American Academy of Orthopaedic Surgeons.  

Researchers surveyed 629 patients being treated at orthopaedic clinics to see how widely cannabis is being used for chronic muscle and joint pain that can be caused by arthritis, fibromyalgia, osteoporosis and many other conditions.

“Over time, we’ve certainly seen an increase in the use of cannabis to manage musculoskeletal (MSK) pain,” said lead author Timothy Leroux, MD, an orthopaedic surgeon and assistant professor at the University of Toronto.

“There is definite interest to see if cannabis can be used to manage chronic MSK pain, as opposed to other conventional treatments such as anti-inflammatories and opioids. With this study, we wanted to get a lay of the land as to who is using it, what proportion are using and what they perceive the efficacy to be.”

One in five of the patients surveyed said they are currently using or have tried cannabis to manage their MSK pain. Of those, 90% said cannabis was effective, 57% believe it works better than other pain medications, and 40% said it decreased their use of other drugs.

Patients who used cannabis for MSK pain were more likely to have multiple conditions, including depression, back pain, chronic pelvic pain and chronic neck pain. They were also more likely to use muscle relaxants and opioids for pain relief.

The most common form of cannabis used was cannabidiol (39%) and the most common route of ingestion was CBD oil (60%). Over a third of patients said they spent at least $200 per month on cannabis products.

Among the cannabis users, only 26% received a recommendation from a physician. Most said they tried cannabis at the urging of a friend or family member.

“Most doctors, especially orthopaedic surgeons, don’t have prescribing power for cannabis, so there is minimal physician oversight when it comes to cannabis use to manage chronic MSK pain,” said Leroux. “To complicate things, it’s a little bit of a Wild West in the cannabis industry in terms of what you get in a product, namely actual vs. labelled composition, and consistency.

“Another challenge is that we don’t fully know what products, formulations, dosages, and routes of administration are best to manage chronic MSK pain. Given the high rate of use observed in this study and little physician oversight, there’s an impetus for us as a medical community to try to understand what role, if any, cannabis may serve in the management of chronic MSK pain.”

Even among non-users, there was a fair amount of interest in cannabis. Sixty-five percent reported an interest in trying cannabis for MSK pain. Common barriers to using cannabis were stigma and lack of knowledge about its efficacy, doses and routes of administration.

“We tend to associate cannabis with a younger age due to recreational use, but in our study, age was not a significant factor influencing use for the management of chronic MSK pain,” said Leroux. “Patients reported use well into their 80’s, many whom we assumed would want to use more conventional products.

“We’d like to repeat this study in the next few years to see how use and demographics change as people become more comfortable with the idea of cannabis as the norm as well as what role state legalization plays in patients’ attitudes towards its use.”

Should Children Be Prescribed Cymbalta?

By Pat Anson, PNN Editor

The Food and Drug Administration has quietly expanded the use of an antidepressant to treat fibromyalgia in pediatric patients between 13 to 17 years of age – despite the known risk of suicidal behavior by children on antidepressant drugs.  

Cymbalta (also known by its generic name, duloxetine) is a serotonin and norepinephrine reuptake inhibitor (SNRI) made by Eli Lilly that was first approved by the FDA as a treatment for depression in 2004.

In the years that followed, Cymbalta’s use greatly expanded as it was also approved as a treatment for anxiety, diabetic neuropathy, chronic musculoskeletal pain and fibromyalgia in adults.

The approvals came with a major caveat: a black box warning label that specifically cautioned patients and providers that “Cymbalta is not approved for use in pediatric patients” because it could increase the risk of suicidal thinking and behavior in children.

2007 Cymbalta warning label

So why is the FDA now approving the use of Cymbalta by children?  

The federal agency issued no press release when it sent a letter to Eli Lilly on April 20 notifying the company that it was approving its longstanding request to allow Cymbalta to be prescribed for juvenile fibromyalgia. Lilly itself has made no public announcement about the approval.

Health and Human Services Secretary Alex Azar, who oversees the FDA, was President of the U.S. division of Eli Lilly from 2012 to 2017, a period when the cost of Cymbalta doubled.

‘No New Safety Concerns’

The FDA’s approval of Cymbalta for pediatric cases appears to be based on a single placebo-controlled study -- sponsored by Eli Lilly -- in which 184 children with juvenile fibromyalgia were given duloxetine, placebo or a combination of the two over the course of 39 weeks.

Eli Lilly not only funded the study, but its employees designed it, collected data, conducted the analysis, and wrote the article that reported on its findings, which was published last year in the journal of Pediatric Rheumatology.

While the study did not show that duloxetine was significantly better than placebo, patients taking the drug did show a modest improvement in pain severity. Notably, Eli Lilly researchers also said they found “no new safety concerns” about duloxetine.

Which doesn’t mean there were no safety concerns, it just means they didn’t find any new ones. Duloxetine is well known to have side effects in adults, such as fatigue, nausea, mood swings and weight gain.

“The safety profile of duloxetine observed in this study was similar to that observed in previous pediatric duloxetine trials of other indications, as well as in duloxetine trials in adults with FM (fibromyalgia). Nausea, headache, vomiting, and decreased appetite were the most frequently reported AEs (adverse events) in the present study, which are similar to those reported previously in adult population with FM,” wrote lead author Himanshu Upadhyaya, Global Lead Physician in Psychiatry at Eli Lilly.

But a closer look at the study findings – which anyone can see for themselves at clinicaltrials.gov – shows that 6 children taking duloxetine exhibited alarming signs of self-harm. There were two attempted suicides and one intentional drug overdose. One child intentionally injured himself and two had suicidal thoughts. Three other children on duloxetine experienced depression, hallucinations and a seizure.

Granted, nine children in total isn’t that many – but in a small study with 184 participants, it’s concerning – especially when no one in the placebo group had the same behavior or symptoms, according to study results posted on the government-run website.

However, in their published findings in Pediatric Rheumatology, Eli Lilly researchers downplayed the suicidal thinking and other side effects associated with duloxetine, saying they were “not significantly different” than those of children on placebo. The two attempted suicides aren’t even mentioned.

“In the present study, the suicidal ideation events reported with duloxetine were not significantly different from placebo-treated patients. Similar results were reported previously, including the exposure-adjusted analysis of suicidal ideation events, which have not shown any significant difference between duloxetine and placebo,” researchers said.

“None of the SAEs (serious adverse events) reported were considered to be study drug-related and none have led to study discontinuation. There were no deaths reported during the study. There were no significant differences between groups in suicide-related behaviors or ideation.”

Eli Lilly went to great lengths to conduct the study. Its researchers said it took almost 7 years and significant recruitment efforts to find enough children to participate with parental approval. Most of the participants were in the United States, but some were recruited as far away as India and Argentina.

Suicide has long been associated with duloxetine, going back to its earliest clinical trials. A 19-year college student participating in one study killed herself in 2004, four days after being taken off the drug. Four other patients who took duloxetine during clinical trials also committed suicide, although Eli Lilly said at the time there was no evidence directly linking those deaths to the drug.

Withdrawal ‘Brain Zaps’

A common complaint of patients who take duloxetine is how quickly they become addicted and what happens when they stop taking the drug. Many complain of severe withdrawal symptoms such as mood swings, nausea, fatigue and electric-like sensations called “brain zaps.”

PNN columnist Crystal Lindell went through withdrawal when she started weaning herself off Cymbalta in 2015. Her column on that experience (see “How I took Myself Off Cymbalta”) has become a reference point for hundreds of patients trying to get off the drug.

Crystal thinks expanding the use of Cymbalta to include pediatric patients is not a good idea.

“I would urge extraordinary caution when it comes to giving Cymbalta to teenagers,” Crystal says. “When I was first given Cymbalta about seven years ago, I was 29. At that time, the doctor told me I may be too young to take it because it was known to cause suicidal thoughts in young people. He advised me to be in touch with him if that starts to happen. And I was much older than the age group they just approved to take this drug.  

“I hope doctors will be more cautious about giving Cymbalta to teenagers than they have been about giving it to adults. I always advise readers to listen to their doctor first and foremost, but don't be shy about pressing them on which medications they prescribe you. Ask them about side effects and withdrawal so that you can feel comfortable about what you’re taking.”

The FDA’s new warning label for Cymbalta still cautions about suicidal thinking and behavior in children, but no longer warns that the drug is not approved for use by pediatric patients.

NEW CYMBALTA WARNING LABEL

Duloxetine’s checkered history is well known at the FDA. The agency’s adverse events reporting system has recorded over 33,500 serious cases involving duloxetine since 2007, most of them classified as psychiatric disorders. Over 3,900 of those adverse events resulted in death.

Although Eli Lilly’s patent on duloxetine expired years ago, Cymbalta remains a top money-maker for the company. Cymbalta sales during the first quarter of 2020 were up 28% from a year ago to more than $210 million.

In addition to treating juvenile fibromyalgia, Cymbalta could be repurposed in other ways to boost sales for Eli Lilly. Over 300 clinical studies are underway to explore the use of duloxetine to treat a smorgasbord of other conditions, including shingles pain, cancer pain, surgical pain, post-traumatic stress disorder, attention deficit disorder, and cocaine addiction.

In short, a drug with risky side effects that was originally developed to treat depression is being used for health conditions it was never intended to treat. And more could be added to the list.

Treating Chronic Pain With Lasers

By Madora Pennington, PNN Columnist

Months after surgery for my badly broken foot, the last scab finally fell off, revealing to my horror that the surgical incision had not closed. I have Ehlers-Danlos Syndrome (EDS), a genetic condition that prevents my body from building proper collagen. Poor wound healing is a common complication for people like me. 

A search for a treatment that would help led me to Dr. Harold Kraft, a Southern California anesthesiologist who has built an entire practice around using high-powered lasers. Kraft’s main focus is pain --- from sciatica and back pain to neuropathy, neuralgia and myalgia, as well as post-surgical pain and soft tissue injuries. 

Another thing lasers do is facilitate wound healing. After a few appointments, my wound closed but appeared fragile and Frankenstein-looking. With more treatments, it rapidly filled in, coming to look smooth, strong and, surprisingly, pretty.

I was eager to try laser for my Ehlers-Danlos aches as well. My strange body seems to sustain soft-tissue injuries from the ordinary tasks of life, draining my energy and taxing my nervous system. From the laser treatments, I experienced relief I had never before felt.

Kraft has learned a lot from administering over 20,000 treatments on patients. He noticed Ehlers-Danlos patients got exceptional pain relief from the laser treatments, and came to find that nearly all are super-responders.

“About 90% of EDS patients respond to laser treatment, and get faster and more profound pain relief than typical patients,” Kraft notes.

Light Amplification

The word “laser" is an acronym for Light Amplification by the Stimulated Emission of Radiation. No longer limited to science fiction movies, lasers are now a part of everyday life. You’ve probably seen lasers used as pointers during presentations, as bar code scanners, and in DVD players. In medicine, lasers can be used for precision cutting, such as in LASIK vision surgery or for excising a tumor. For cosmetic purposes, a laser can improve skin imperfections or whiten teeth.

Light particles, or photons, from the laser pass through the skin and stimulate the cells’ mitochondria to release anti-inflammatory modulators, nerve and vascular growth factor. This causes healing and repair.

Kraft came to having a pain practice late in life. He had retired from a long career of performing anesthesia during surgery and left medicine entirely for the business world, developing software for data aggregation. All that changed when his wife took their long-suffering pug for a new treatment.

Harley, a most beloved dog, had trouble walking. He had not benefited from joint supporting supplements like glucosamine and chondroitin, nor acupuncture and doggie physical therapy. But after four treatments of high dose laser from a veterinarian, Harley could walk again. The Kraft’s were elated and also intrigued.

Kraft convinced a family friend who had back pain to see that same veterinarian for lasering, even though she is a human. Like Harley, she found pain relief.

Seeing the promise of what this could offer, Kraft began training in laser techniques and got laser machines of his own. He went back to practicing medicine, treating pain exclusively with lasers. Kraft uses Class IV lasers, which are the most powerful available. He employs them at high doses, in order to do the most good for patients. Great care must be taken in this endeavor.

“The more power you use, the more care you need to operate and the more likely that misapplication can cause harm,” Kraft says. “There is no discomfort during treatment, although the patient may feel the heat from the laser. It is powerful, non-invasive, and the results can be permanent or long-lasting.”

Kraft says about 7 out of 10 patients get significant improvement, including chronic pain sufferers who failed at other treatments. Genetics seem to play a factor in how well a patient responds. Some are just faster than others. A small percentage respond immediately. Most experience benefit between 4 and 10 treatments, and only about 30% do not respond after 14 or so treatments.

What does the science say about laser therapy? While there isn’t an abundance of research on the healing power of Class IV laser, some exist and are worth noting:

• A small study in the Journal of Athletic Training concluded that Class IV laser therapy is “an effective treatment modality to increase blood flow in the soft tissues” to promote healing.

• A pilot study assessed Class IV laser therapy for postoperative pain in 100 patients who had coronary bypass surgery, and found it to be effective.

• A double-blind study of tendonitis caused by repetitive-motion found Class IV laser treatments gave long-term relief with no adverse effects.

• Another double-blind study on 38 women with fibromyalgia showed that Class IV laser therapy improves pain, upper body range of motion, and quality of life. 

Chronic and acute pain are notoriously difficult to treat, especially in an era when fewer doctors are willing to treat pain or prescribe opioid medication. Pain patients have fewer options.

Dr. Kraft imagines a world where patients will have easy access to laser therapy at their primary care doctor or physical therapist. In addition to running his busy practice, Dr. Kraft has invented an improved laser, one that would optimize treatment regimen. He hopes to have it to market in two years.

Madora Pennington writes about Ehlers-Danlos and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

I Can’t Imagine Life Without Kratom

By Kimberley Flink, Guest Columnist

I'm 59, a native Floridian and spent most of my entire life actively outdoors. About five years ago, I woke up and could barely move, my body was wracked with intense muscle pain. I was in tears simply brushing my teeth, taking a shower, holding a coffee cup or even opening a door.

If I had to attempt to describe the pain, it would be similar to doing a triathlon and never practicing a day for it. Every muscle ached and throbbed in constant, chronic soreness. I felt like a little old lady when walking, standing and sitting, with groans of pain to boot.

Finally, after several trips to the doctor, they diagnosed me with fibromyalgia and a series of drugs were prescribed: anti-depressants, muscle relaxers, gabapentin and all the typical prescribed pharma arsenals.

Nothing helped with the pain. Instead they gave me side-effects that ranged from horrid headaches, weird sensations in my body, and the list goes on. So I set out to approach a holistic natural path.

Marijuana made me overeat and I didn't like staying high. I cleaned up my diet, took organic superfoods and spent tons on supplements, all to no avail.

Then a friend recommended kratom. And from the first day of taking it I was literally in tears, thanking God for a respite.

I do not even take the recommended dosage, so as to not overuse it, and I do not take kratom every single day, so I do not become addicted.  On the days I don’t take it, I'm suffering and hardly able to get out of bed.

KIMBERLEY FLINK

I cannot imagine my life without kratom, as I am now able to spend time with my granddaughter, go on short outings and function somewhat normally. I do not get high, overeat and have no ill side effects. It gives me a little energy and dials down the pain level severely. 

It would be a serious injustice to not have kratom available to people like myself, who suffer with chronic pain and do not want the heavy-duty drugs that people get addicted to or take their life by overdosing.

To compare kratom with alcohol, nicotine, opioids or other drugs that can cause death is absurd. I know what addiction is and those who say otherwise are simply abusing kratom. Or they’re using some other black market, knock-off product.

Kratom is the only thing that has given me a good portion of a quality life back. I thank God for it!

Kimberley Flink lives in Florida.

Pain News Network invites other readers to share their stories with us. Send them to:  editor@PainNewsNetwork.org. 

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.

Domestic Abuse Survivors Have Twice Risk of Fibromyalgia

By Pat Anson, PNN Editor  

Ava Shypula had a difficult childhood growing up in communist Poland. She was physically abused by her father and was left home alone for hours, sometimes days at a time. Ava became chronically ill at a young age. 

“My symptoms began very early, almost as far as I remember. They started with joint pain, chills and constant flu like symptoms, with a sore, inflamed throat,” Ava recalls. 

Even after marrying a doctor and leaving Poland to begin a new life in New York City, Ava’s symptoms persisted. 

“My then-husband ignored my symptoms, focusing on his own career and studying in order to re-certify his medical diploma,” she said. “The fear of failure, pride and ambition to succeed only advanced the illness, which at that time was diagnosed as chronic fatigue syndrome.” 

Only after her marriage ended in a nasty divorce did Ava begin to understand her illness and the role played by stress. She was diagnosed with fibromyalgia – a poorly understood disease characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. 

A neurologist prescribed Lyrica and Ava’s symptoms began improving. 

“For many years women with undiagnosed fibromyalgia had been dismissed as hysterics having emotional issues,” she said. “Together with a fantastic help from my psychiatrist, my symptoms slowly but noticeably diminished, not fully, but they have become more manageable.”

Abuse Causes Physical and Psychological Stress

Ava Shypula’s story is not unique. In fact, it is all too common, according to a large new study that found female survivors of domestic abuse have nearly twice the risk of developing widespread body pain and chronic fatigue syndrome (CFS).

Researchers at the Universities of Birmingham and Warwick in the UK examined the medical records of over 18,500 women who suffered domestic abuse and compared them to 74,000 women who did not. Health data was collected from 1995 to 2017.

The study, published in the Journal of Interpersonal Violence, is one of the first designed to assess the relationship between women who have been abused and the likelihood of them developing long-term illnesses such as fibromyalgia.

"Survivors of domestic abuse can experience immense physiological and psychological stress,” said Professor Julie Taylor of the University of Birmingham's School of Nursing. “The changes that happen in the body as a result of such stress can lead to a multitude of poor health outcomes such as what we see in our study here.

"This is a very complex relationship and it is important to emphasize that not all women who have been abused will develop fibromyalgia or CFS, and that having these conditions does not mean there has been domestic abuse in the past."

Previous research has found that about one in every four women in the UK have experienced some form of domestic abuse, with a large proportion of those cases being violence at the hands of an intimate partner. Globally, about one in three women suffer domestic abuse.

"Considering the prevalence of domestic abuse, and the fact that patients experiencing fibromyalgia and CFS often face delays in diagnosis due to a limited understanding generally of how these conditions are caused, it is important for clinicians to bear in mind that women who have survived abuse are at a greater risk of these conditions,” said Dr. Joht Singh Chandan of the University of Birmingham's Institute of Applied Health Research and Warwick Medical School.

"We hope these first of their kind research findings will change healthcare practice and will be of assistance in the early diagnosis of fibromyalgia and CFS in women who have been abused."

Ava Shypula hopes that sharing her story will help other women understand their illness, get treatment and make lifestyle changes to reduce stress. She’s learned that avoiding cold temperatures, staying warm and getting a good night’s sleep will reduce her symptoms. 

“Encourage them to fight back instead of resigning and living with pity and depression, which I have experienced at different points of my life,” she told PNN. “I have found that emotional support plays a major role to fight with this illness.”

Living Well With Fibromyalgia

By Lynn Phipps, Guest Columnist

In 2016, as a guest columnist for PNN, I shared my story of being diagnosed with fibromyalgia and the offending ways I was treated by the medical community for having an invisible illness.

If my first column was about finding hope, then this one is about getting well and living well with fibromyalgia. I hope that you will be inspired by my story and know that there is a way for you to reclaim your lives from the devastating illness that is fibromyalgia.

For years I felt alone. I am not alone. Neither are you.

In 2003, I knew something was very wrong when I could no longer effectively do my job as a social worker. ​I was in constant pain, had a 24/7 headache and migraines twice a week or more, and could not fully concentrate. Insomnia and anxiety had me awake most nights.

Desperate to get well, I spent half of my paycheck on herbs, supplements, massage, hydrotherapy, acupuncture, chiropractic, ​Rolfing​and Reiki​. Nevertheless, I continued getting worse. When I could no longer afford alternative treatments not covered by my health insurance, my body crashed.

Having suffered from unrelenting migraines for months, my final career ending moment came when my back and neck spasmed, causing me to fall to the floor in my office at work. I remained on hands and knees for 20 minutes before being able to crawl to my desk to pull myself up.

I do not remember driving home, nor did I realize that moment signaled the end of my 20-year career as a social worker caring for those with disabilities (ironic, I know).

I was diagnosed by my doctor with fibromyalgia, chronic pain, severe headaches and migraines, light and sound sensitivity, depression, insomnia, anxiety and PTSD. 

The Guaifenesin Protocol

LYNN PHIPPS

Over the next decade, it became my job to research and find help for my condition. The problem was that none of the specialists looked at fibromyalgia as a cause for all that I was experiencing. And not one physician ever looked at food allergies or diet as a potential cause, even though I have a family history of diabetes.

That is significant because 44% of “fibromyalgics” also have a second and separate disease called hypoglycemia.  Another 15% of fibromyalgics have hypothyroidism, another disease with overlapping symptoms, including fatigue, muscle pain and impaired memory, to name just a few. I am unlucky enough to have this grand trifecta of illness. 

With nearly all hope gone, an internet search for headache specialists in northern California led me to Dr. Melissa Congdon, a fibromyalgia specialist. ​​It was through her that I finally understood that the headaches and migraines were related to the fibromyalgia, and not whiplash from a car accident or a repetitive motion injury from work, as every doctor and specialist had assumed. 

During my first appointment, my fibromyalgia diagnosis was confirmed by Dr Congdon. I was also diagnosed with hypoglycemia. Again, this is significant because about half of us with fibromyalgia also have hypoglycemia, with overlapping symptoms such as fatigue, pain and impaired memory.

In order to get our health back, these two separate diseases require two separate treatments: Dr R. Paul Saint Amand’s Guaifenesin Protocol and his HG Diet for fibroglycemia.,

The protocol requires taking the expectorant drug guaifenesin (Mucinex), which clears airways in the lungs and helps the kidneys reduce the buildup of inorganic phosphates in the body. The low-carbohydrate diet combats low blood sugar, which mimics many fibromyalgia symptoms.

Within 2 months of following the protocol and diet, I began to see improvement in generalized body pain, headaches and migraines, chronic fatigue and brain fog. After 20 months, I got “me” back, and so did my family. 

Many people have mentioned that they do not want to follow the protocol because they have heard that it will make them feel worse. To this we say, “It’s pain with a purpose.”  We strive for finding our own individual dose of guaifenesin that will leave us “functionally” worse, not incapacitated. As long as we do nothing, the phosphates will continue to accumulate throughout the body, causing fibromyalgia symptoms to continually worsen.

The Guaifenesin Protocol will clear the offending phosphates from our kidneys at a rate of approximately​ ​1 year of symptoms in just 2 months. I was symptomatic for 10 years before starting the protocol and had reversed all of my symptoms within 20 months. By the first year on the protocol, I was off of all pain medication. 

My Awakening

The 13 years that I spent bed-bound seem like a bad dream. It was quite an adjustment getting my health back after so much time. It felt as if I’d been existing in a semi-comatose state. While I’d been so ill, my mother passed from pancreatic cancer and both daughters moved out, graduated from college and started their adult lives. 

I had physically been there for all of that, but with such severe fatigue and brain fog, it all had a feeling of unreality to me. Upon “awakening” I was shocked by my appearance, as I’d been only 38 when I got sick and had “awakened” at age 51. My husband and I had to get to know each other all over again. Luckily, we fell in love all over again. 

After the brain fog and severe fatigue had cleared, I wanted to go back to work, but I knew that I could not be a social worker again. Many fibromyalgia symptoms are brought on by physical or emotional trauma. The stress of being a social worker ruled that out, so I decided to do something quite different. I put my years of watching HGTV while bedbound to use by becoming certified in home staging and redesign.  I enjoyed a successful home staging business for 3 years before retiring.

I now spend my days educating others on the Guaifenesin Protocol, helping those still suffering from fibromyalgia get their lives back, too.

(Editor’s note: For a contrarian view on the Guaifenesin Protocol, click here.)

Lynn Phipps lives in northern California. Lynn has created a website called Living with Fibromyalgia to assist beginners in getting started on the Guaifenesin Protocol.

Pain News Network invites other readers to share their stories with us. Send them to: editor@PainNewsNetwork.org. 

This column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Low Dose Naltrexone a ‘Game Changer’

By Alex Smith, Kaiser Health News

Lori Pinkley, a 50-year-old from Kansas City, Mo., has struggled with puzzling chronic pain since she was 15.

She has had countless disappointing visits with doctors. Some said they couldn’t help her. Others diagnosed her with everything from fibromyalgia to lipedema to the rare Ehlers-Danlos syndrome.

Pinkley has taken opioids a few times after surgeries, but they never helped her underlying pain. Recently she joined a growing group of patients using an outside-the-box remedy: naltrexone. It is typically used to treat addiction to opioids or alcohol, in pill form or as a monthly shot.

As the medical establishment attempts a huge U-turn after two disastrous decades of pushing long-term opioid use for chronic pain, scientists have been struggling to develop safe, effective alternatives.

When naltrexone is used to treat addiction in pill form, it’s prescribed at 50 milligrams. But chronic pain patients say it helps their pain at doses of less than a tenth of that.

Low-dose naltrexone (LDN) has lurked for years on the fringes of medicine, and its zealous advocates worry it may be stuck there. Naltrexone, which can be produced generically, is not even manufactured at the low doses that seem best for pain patients.

Instead, patients go to compounding pharmacies or resort to DIY methods — YouTube videos and online support groups show people how to turn 50 mg pills into a low-dose liquid.

Some doctors prescribe it off label even though it’s not FDA-approved for pain.

University of Kansas pain specialist Dr. Andrea Nicol recently started prescribing LDN to her patients, including Pinkley. Nicol explained that for addiction patients it works by blocking opioid receptors — some of the brain’s most important feel-good regions. So it prevents patients from feeling high and can help patients resist cravings.

At low doses of about 4.5 mg, however, naltrexone seems to work differently.

“What it’s felt to do is not shut down the system, but restore some balance to the opioid system,” Nicol said.

Some of the hype over low-dose naltrexone has included some pretty extreme claims with limited research to back them, like using it to treat multiple sclerosis and neuropathic pain or even using it as a weight-loss drug.

In the past two years, however, there’s been a significant increase in new studies published on low-dose naltrexone, many strengthening claims of its effectiveness as a treatment for chronic pain, though most of these were small pilot studies.

Dr. Bruce Vrooman, an associate professor at Dartmouth’s Geisel School of Medicine, authored a recent review of low-dose naltrexone research.

Vrooman said that, when it comes to treating some patients with complex chronic pain, low-dose naltrexone appears to be more effective and well-tolerated than the big-name opioids that dominated pain management for decades.

“Those patients may report that this is indeed a game changer. It may truly help them with their activities, help them feel better.”

— Dr. Bruce Vrooman

“Those patients may report that this is indeed a game changer,” Vrooman said. “It may truly help them with their activities, help them feel better.”

So how does it work? Scientists think that for many chronic pain patients the central nervous system gets overworked and agitated. Pain signals fire in an out-of-control feedback loop that drowns out the body’s natural pain-relieving systems.

They suspect that low doses of naltrexone dampen that inflammation and kick-start the body’s production of pain-killing endorphins — all with relatively minor side effects.

Drug Companies Not Promoting LDN

Despite the promise of naltrexone, its advocates say, few doctors know about it. The low-dose version is generally not covered by insurance, so patients typically have to pay out-of-pocket to have it specially made at compounding pharmacies.

Advocates worry that the treatment is doomed to be stuck on the periphery of medicine because, as a 50-year-old drug, naltrexone can be made generically.

Patricia Danzon, a professor of health care management at the Wharton School at the University of Pennsylvania, explains that drug companies don’t have much interest in producing a new drug unless they can be the only maker of it.

“Bringing a new drug to market requires getting FDA approval, and that requires doing clinical trials,” Danzon said. “That’s a significant investment, and companies — unsurprisingly — are not willing to do that unless they can get a patent and be the sole supplier of that drug for at least some period of time.”

And without a drug company’s backing, a treatment like low-dose naltrexone is unlikely to get the promotional push out to doctors and TV advertisements that has made household names of drugs like Humira and Chantix.

 “It’s absolutely true that once a product becomes generic, you don’t see promotion happening, because it never pays a generic company to promote something if there are multiple versions of it available, and they can’t be sure that they’ll capture the reward on that promotion,” Danzon said.

The drugmaker Alkermes has had huge success with its exclusive rights to the extended-release version of naltrexone, called Vivitrol. In a statement for this story, the company said it hasn’t seen enough evidence to support the use of low-dose naltrexone to treat chronic pain and therefore is remaining focused on opioid addiction treatment.

Lori Pinkley said it’s frustrating that there are so many missing pieces in the puzzle of understanding and treating chronic pain, but she, too, has become a believer in naltrexone.

She’s been taking it for about a year now, at first paying $50 a month out-of-pocket to have the prescription filled at a compounding pharmacy. In July, her insurance started covering it.

“I can go from having days that I really don’t want to get out of bed because I hurt so bad,” she said, “to within a half-hour of taking it, I’m up and running, moving around, on the computer, able to do stuff.”

A recent review by British researchers found that LDN is safe to use and more clinical studies are needed on its potential uses. PNN readers have shared their positive experiences using LDN to treat Interstitial Cystitis and fibromyalgia.

The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.

This story is part of a partnership that includes KCUR, NPR and Kaiser Health News, a nonprofit news service covering health issues. KHN is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Fibromyalgia Researchers, It’s Time to Stop Watching the Flowers Grow!

By Donna Gregory Burch

As a fibromyalgia warrior and blogger, I read a lot of articles about new research findings. I continue to be amazed by how much time and money are wasted by researching the obvious or studying the same treatments over and over again.

After all, how many times do we need to prove meditation can reduce fibromyalgia pain? Didn’t we figure that out years ago?

I really thought I’d seen it all until an article entitled, “The Power of Flowers May Ease Fibromyalgia Symptoms,” showed up in my inbox last month.

As I read it, I literally said out loud: “Are you kidding me?”

In case you haven’t read the article, it summarizes a recent Israeli study in which 61 women with fibromyalgia completed a 12-week flower design course presented by a trained florist. At the end of the course, Tel-Aviv University researchers reported “quite amazing” improvements in the women’s fibromyalgia symptoms.

Yep, you read that right: The researchers claim arranging a few daisies and baby’s breath in a vase actually improves fibromyalgia.

Now, I don’t doubt for a minute that flower arranging is relaxing and could have a calming effect on the central nervous system. That, in turn, could lead to a reduction in pain and other fibro symptoms.

But so could watching butterflies or painting rocks.

While I think it’s wonderful researchers are looking at non-pharmaceutical treatments for fibromyalgia, studies like this completely invalidate the seriousness of our condition. These types of studies make it seem like almost anything will fix fibro, and that is just not reality.

Because of the stigma of fibromyalgia, we already struggle to prove to our doctors and loved ones that we’re really sick. What do you think the average person is going to think when they read flower arranging helps fibromyalgia? While I’m sure the researchers had good intentions, this study makes a complete mockery and joke out of an extremely painful, life-sucking condition.

In my mind, I think back to all of those doctors who tried to give me anti-depressants and anti-anxiety medications when I complained about unexplained pain, fatigue, bladder urgency, neuropathy and a long list of other symptoms. The message was clear: “It’s all in your head. You’re just a stressed out, middle-aged woman who needs to chill out.”

What happens when these same doctors read the Israeli study? I can envision them now referring their patients to the nearest community college for classes on cupcake baking and basket-weaving. As if we weren’t frustrated enough with the conventional medical system!

The truth is we don’t need more BS fibromyalgia studies like this one. We need researchers to get serious! We need them to take a deep dive into the minds and bodies of fibromyalgia patients and figure out what causes us to feel like a three-day-old warmed over microwave dinner.

We need real solutions – treatments that get to the root cause of our illness – not a new hobby!

Donna Gregory Burch lives with fibromyalgia and chronic Lyme disease. Donna covers news, treatments, research and practical tips for living with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter.

Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.

Don’t Add to My Pain

By Mia Maysack, PNN Columnist

This month I celebrate the anniversary of finally getting a fibromyalgia diagnosis, after years of fighting to “earn” it. To my lifelong course of chronic migraine was added a heaping side dish of a nerve disorder.

Intractable pain is a constant state of being for me, whether I use essential oils, think positive, drink pickle juice for 40 days and nights, or even if someone belittles, disbelieves, mocks or minimizes it.    

People often say things like "I wouldn't be able to make it” if their head hurt like mine does every day. For many, there's no possible way to imagine what it is like, but I'm finding that those who cannot relate at all often have the most opinions about it.

Others wonder how I've been able to accomplish what I have while under the persistent weight of brain discomfort. The answer is simple: Because I've had no other choice!

When not entirely incapacitated, head pain for me has been managed with a grateful attitude and a mind over matter approach. Unfortunately, when navigating matters of the physical body, more restrictions apply.  Neither deep breaths nor the tapping of my ruby red slippers will get me up or down the stairs when I'm unable to walk. 

Many around me have taken all of this personally, because the extent of the hardships I face have left me trapped behind closed doors more than ever. 

Instead of stopping by or reaching out to check in, entire relationships have changed -- primarily because my ailments have yet to be acknowledged, let alone respected.

Only recently did others finally begin to grasp the concept of my migraine and cluster headaches.

But wrapping their minds around something else? Especially when I lack the energy and desire to continually attempt to justify or explain? Forget about it. 

One thing about me is that I rarely ever complain. I'm known to seek out silver linings and hand the light I find over to the next person in need. I count my blessings on a regular basis and never lose sight as to how much worse things could be or how they can change in the blink of an eye.

So, when attempting to bare my soul while being met with judgment, doubt, questioning or just flat out disregarded, I wonder if those who respond that way ever stop to reflect. Shifting blame toward me or my conditions for our lack of fellowship or communication doesn’t help the relationship.   

Not long ago I was out at a dinner, constantly having to shift in the chair or get up to stand, while repeatedly being reminded what we're conversing about due to brain fog. All the while my head is banging and I can barely eat because the nausea from attempting to ignore everything else was heightening.   

The dear one I'm out with mentions another friend who endures similar circumstances. He proceeds to explain how he's had to carry this person out of places and into their home due to the extent of their fatigue. Hearing this tears me up because I can literally feel for them.  

But instead of using this opportunity to bond, my emotion was met with ridicule: "You are SO sensitive! I cannot talk about ANYTHING with you!"  

It felt like insult to injury, that they'd demonstrate compassion for another but then put me down.   

Before that, someone else I love labeled my chronic pain as a "placebo effect." More recently, even after discussing my disability hearing, a friend wondered if I had a gym membership because they didn’t want to work out alone.  

Not that it is blasphemous to bring up the topic of exercise, but it showed a lack of empathy. If I am in need of using a cane, not always able to drive, experience muscle failure and soreness to the touch, what about that signifies my readiness to lift weights or hop on a treadmill?

I used to go out dancing regularly, but the last time was about 24 months ago for an ex co-worker's bachelorette party -- whose actual wedding I ended up missing because of all this. Another homie of mine hasn't replied to me since I'd been forced to cancel attending her kid’s birthday party at the last minute.  

Quite honestly, if I keep in contact with just about anyone, it's because I initiate the connection. Many have flat out stopped talking to me altogether because my consistent need for self-care is an inconvenience for them.  

What they don't know is that all of this is so real. The other day, I purposefully went outside in the rain to pre-shower, because with Mother Nature's help the chore felt slightly less daunting. 

Having been dealt this hand and then being left to cope on your own has a way of demonstrating the extent of one’s strength they may not have realized they had. I am thankful for everything that broke me because that’s what I am made of.

I now declare unapologetically that all of this has forced me to change. Nothing is welcome in my life that adds more hurt or disrupts my peace. My hope is that everyone reading this reaches the same conclusion and thereby a level of freedom.    

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Are You Paying Too Much for Pregabalin?

By Pat Anson, PNN Editor

It didn’t take long for cheaper generic versions of pregabalin to take a bite out of Pfizer’s monopoly of Lyrica, a drug widely used to treat fibromyalgia, diabetic neuropathy and other types of chronic pain.

Last month the U.S. Food and Drug Administration gave approval to rival drug makers to begin selling generic pregabalin after Pfizer’s patent on Lyrica expired. According to FiercePharma, Pfizer lost about a third of the market for pregabalin to 16 competitors by the end of July.  

It’s not hard to see why. According to Healthcare Bluebook, a 60-day supply of 75mg Lyrica sells for a “fair price” of $472. That compares to generic versions that sell for about $28.

“The price that most patients pay is set by insurers. The cost difference for patients between brand-name Lyrica and generic pregabalin may vary depending on the patients’ insurance plan, the state in which their prescription is filled, or the pharmacy where they pick up their prescription,” said Steven Danehy, a Pfizer spokesman.

As of August 9, Lyrica still had about 43% of the market for pregabalin, but that’s likely to change as patients, doctors and insurers became more aware of the significant difference in price.

Pregabalin is approved by the FDA for the treatment of pain associated with shingles, spinal cord injury, fibromyalgia, and diabetic peripheral neuropathy. It is also commonly prescribed "off label" for other types of chronic pain.

Pregabalin is a Schedule V controlled substance, which means it has a low potential for abuse. In recent years, however, there is growing concern that pregabalin and its sister drug gabapentin (Neurontin) are being abused and overprescribed.

The drugs, which belong to a class of nerve medication called gabapentinoids, were originally developed to treat epilepsy, not pain. Prescriptions for gabapentinoids have tripled over the past 15 years as more doctors prescribed them as “safer” alternatives to opioids.

Deaths involving gabapentinoids have increased in the UK, Australia and Canada, where some addicts have learned the drugs can heighten the euphoric effect of heroin and other opioids. The drugs were recently classified as controlled substances in the UK.

FDA Approves First Generics for Lyrica

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved the first generic versions of Lyrica (pregabalin), a medication widely prescribed for the treatment of fibromyalgia, diabetic neuropathy and other types of chronic pain.

Lyrica has been a blockbuster drug for Pfizer since its approval in 2004, generating revenue of $4.6 billion annually. The recent expiration of Pfizer’s patent on Lyrica opened the door to much cheaper generic competitors.

A one year supply of Lyrica currently costs about $2,800 in the United States, according to Healthcare Bluebook, while a similar dose of pregabalin under the UK’s National Health Service costs about $74.

“Today’s approval of the first generics for pregabalin, a widely-used medication, is another example of the FDA’s longstanding commitment to advance patient access to lower cost, high-quality generic medicines,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“The FDA requires that generic drugs meet rigorous scientific and quality standards. Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA.”

The FDA granted approvals for generic pregabalin to 9 drug makers: Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.

Pfizer’s patent for Lyrica CR — an extended released version of Lyrica — remains in effect until April, 2021.

Side Effects

The most common side effects for Lyrica are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain and difficulty concentrating. Lyrica’s warning label also cautions users that the drug may cause suicidal thoughts in about 1 in 500 people.

Pregabalin is classified as Schedule V controlled substance in the U.S., which means it has a low potential for abuse. In recent years, however, there is growing concern that pregabalin and its sister drug gabapentin (Neurontin) are being abused and overprescribed. The drugs were recently classified as controlled substances in the UK.

Pregabalin and gabapentin were originally developed to prevent epileptic seizures, but their use has tripled over the past 15 years as more doctors prescribed them off-label as “safer” alternatives to opioids.

A recent study in the British Medical Journal found the drugs increase the risk of suicide, overdose and traffic accidents in younger people. The risks were strongest for those taking pregabalin and were most pronounced among adolescents and young adults aged 15 to 24. Patients aged 55 and older taking gabapentinoids were not at greater risk.

Cannabis Effective in Treating Fibromyalgia

By Pat Anson, PNN Editor

Cannabis significantly reduces pain and improves quality of life for patients with fibromyalgia, according to Israeli researchers who conducted one of the first studies to look at the effectiveness of cannabis in treating fibromyalgia.

Nearly 300 patients diagnosed with fibromyalgia completed the 6-month study at a Tel Aviv clinic. Participants suffered from fibromyalgia symptoms for a median length of seven years and nine out of ten reported constant daily pain. Fibromyalgia is characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Standard treatments for fibromyalgia often prove to be ineffective.

"It is commonly accepted that chronic pain can be treated with cannabis, but there is scarce evidence to support the role of medical cannabis in the treatment of fibromyalgia specifically," says Lihi Bar-Lev Schleider, head research scientist at Tikun Olam, a cannabis producer that sponsored the study.

Patents began with a low dose of cannabis every 3-4 hours that was gradually increased until it had a therapeutic effect.

Participants were treated with two Tikun Olam strains of cannabis; the high-THC “Alaska” strain and the high-CBD “Avidekel” strain, which has virtually no THC.  Both strains are available as a tincture, topical oil or for use in a vaporizer.

Over 80 percent of the patients reported at least moderate improvement in their pain. At the start of the study, the median pain level for patients on a 1 to 10 scale was 9, but after six months the median pain level was reduced to 5.

In addition to lower pain intensity, nearly 93 percent of patients said they slept better and about 80 percent said there was improvement in their depression. Nearly two-thirds said their quality of life was good or very good. Appetite and sexual activity also improved.

The most common side effects were relatively minor, including dizziness, dry mouth and gastrointestinal symptoms.

“Our data indicates that medical cannabis could be a promising therapeutic option for the treatment of fibromyalgia, especially for those who failed on standard pharmacological therapies. We show that medical cannabis is effective and safe when titrated slowly and gradually,” researchers reported in the Journal of Clinical Medicine.

“Considering the low rates of addiction and serious adverse effects (especially compared to opioids), cannabis therapy should be considered to ease the symptom burden among those fibromyalgia patients who are not responding to standard care.”

During the study, about one out of five patients either stopped or reduced their use of opioid pain medication or benzodiazepines while taking cannabis.

Medical marijuana has been legal in Israel since the early 1990s. A recent survey found about 27 percent of Israeli adults have used cannabis in the past year, one of the highest rates in the world.