Gabapentinoids Raise Risk of Suicide and Overdose in Younger People

By Pat Anson, PNN Editor

Gabapentinoids – a class of nerve medication widely prescribed to treat chronic pain – increase the risk of suicide, overdose, traffic accidents and head or body injuries in younger people, according to a large new study published in The British Medical Journal.

Sales of the two main gabapentinoids, pregabalin (Lyrica) and gabapentin (Neurontin), have tripled in recent years in the United States, where they are often promoted in prescribing guidelines as safer alternatives to opioids.

A team of researchers followed nearly 192,000 people enrolled in the Swedish Prescribed Drug Register who filled prescriptions for gabapentinoids on at least two consecutive occasions from 2006 to 2013. That information was compared to data in the Swedish Patient Register, which collects information on hospital admissions and outpatient care, as well as the Swedish Cause of Death Register.

Over the study period, researchers found that patients taking gabapentinoids had higher rates of suicide or suicidal behavior (5.2%), unintentional overdose (8.9%), traffic accidents (6.3%) and head or body injuries (36.7%) than the general population.

The risks were strongest for people who were prescribed 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.

Researchers believe the drugs may have more impact on younger people because they have faster metabolisms, which could lead to withdrawal problems that affect their impulsivity and emotions.

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“Overall, gabapentinoids seem to be safe for a range of outcomes in older people. However, the increased risks found in adolescents and young adults prescribed gabapentinoids, particularly for suicidal behaviour and unintentional overdoses, warrant further research,” said lead author Seena Fazel, MD, of the University of Oxford in England.

“If our findings are triangulated with other forms of evidence, clinical guidelines may need review regarding prescriptions for young people, and those with substance use disorders. Further restrictions for off-label prescription may need consideration.”

Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries; while gabapentin is approved for epilepsy and post-herpetic neuralgia. Both drugs are also widely prescribed off-label to treat back pain, depression, migraine and other chronic conditions.

Gabapentinoids are increasingly being used recreationally by addicts who have found the medications enhance the effects of heroin and other opioids. The drugs were recently classified as controlled substances in the UK.

Gabapentin is not currently scheduled as a controlled substance by the DEA, while Lyrica is classified as a Schedule V controlled substance, meaning it has low potential for addiction and abuse.  

A recent clinical review found little evidence the drugs should be used off-label to treat pain and that prescribing guidelines often exaggerate their effectiveness. The CDC’s controversial opioid guideline, for example, calls gabapentin and pregabalin “first-line drugs” for neuropathic pain.

“Despite documentation that these drugs were promoted improperly for off-label treatment of pain, the recent rapid increase in prescribing of gabapentinoids suggests a persisting sense among clinicians that gabapentinoids are highly effective pain medications,” wrote Christopher Goodman, MD, and Allan Brett, MD, of the University of South Carolina School of Medicine.

“Guidelines and review articles have contributed to this perception by often uncritical extrapolation from FDA-approved indications to off-label use.”

Doctors Say Guidelines Exaggerate Effectiveness of Lyrica and Neurontin

By Pat Anson, PNN Editor

There is little evidence that gabapentin (Neurontin) and pregabalin (Lyrica) should be used off-label to treat pain and prescribing guidelines often exaggerate their effectiveness, according to a new clinical review in JAMA Internal Medicine.

Gabapentin and pregabalin belong to a class of nerve medication known as gabapentinoids. The drugs were originally developed to prevent seizures, but their use has tripled over the past 15 years as more doctors prescribed them for a variety of chronic pain conditions. It is a common practice for doctors to prescribe drugs “off label” for treatments that are not FDA-approved.

“Gabapentinoids have become frequent first-line alternatives in patients with chronic pain from whom opioids are being withheld or withdrawn, as well as in patients with acute pain who traditionally received short courses of low-dose opioid,” wrote Christopher Goodman, MD, and Allan Brett, MD, of the University of South Carolina School of Medicine.

“The evidence to support off-label gabapentinoid use for most painful clinical conditions is limited. For some conditions, no well-performed controlled trials exist.”

Gabapentin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but it is prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder.  Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries, but it is also widely prescribed off-label to treat other types of pain.

The drugs are sold by Pfizer under the brand names Lyrica and Neurontin. The company has paid nearly $1 billion in fines for misleading and improper marketing of the drugs for off-label use.

“Despite documentation that these drugs were promoted improperly for off-label treatment of pain, the recent rapid increase in prescribing of gabapentinoids suggests a persisting sense among clinicians that gabapentinoids are highly effective pain medications,” the doctors wrote.

“Guidelines and review articles have contributed to this perception by often uncritical extrapolation from FDA-approved indications to off-label use.”

Goodman and Brett say the wording in many medical guidelines “reinforces an inflated view of gabapentinoid effectiveness” by falsely claiming the drugs should be used to treat all types of nerve pain.

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“Another example is the 2016 guideline on opioid prescribing from the U.S. Centers for Disease Control and Prevention, which states broadly that gabapentin and pregabalin are first-line drugs for neuropathic pain, without further detail or specification,” they wrote. “Even for treatment of diabetic neuropathy (for which pregabalin is FDA approved and gabapentin is off-label), guideline conclusions tend to exaggerate effectiveness.”

Many patients who take gabapetinoids have side-effects such as dizziness or drowsiness, and there are an increasing number of reports that the drugs are being abused and sold on the street.   

Goodman and Brett have sounded the alarm before about the drugs, warning in a 2017 commentary in the The New England Journal of Medicine that “gabapentinoids are being prescribed excessively.”

They say doctors should do a better job warning patients about the side effects of gabapentinoids and the drugs should be stopped if a patient reports little or no benefit.  They also think medical guidelines should be revised to stop the promotion of gabapentinoids for any pain labeled as neuropathic.

Risky Combination: Opioids and Gabapentin

By Pat Anson, PNN Editor

Opioid medication significantly reduces low back pain, but opioids should not be used in combination with gabapentin (Neurontin) because of their limited effectiveness and potential for abuse, according to the authors of a small new study presented at the annual meeting of the American Academy of Pain Medicine.

"In these days, when we are focusing on reduction of opioids due to opioid crisis in the U.S., gabapentin could be an important part of multimodal non-opioid pain management," N. Nick Knezevic, MD, of the University of Illinois in Chicago told MedPage Today. "However, it should not be given to all patients since the effectiveness in chronic pain patients, particularly in those with low back pain, is limited."

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In a retrospective study, Knezevic and his colleagues looked at 156 patients with low back pain; half of whom were treated with opioids alone and the other half with a combination of opioids and gabapentin.

“According to our study, the combination of gabapentin with opioids was not statistically superior in providing pain relief, in contrast to opioids alone, in patients with chronic pain. Our results are in line with recent guidelines for low back pain treatment that reflect the need to assess the recommendation of gabapentinoids for chronic pain in patients already taking opiods to mitigate risk factors of abuse and overdose,” researchers found.

Gabapentin is an anticonvulsant that was originally developed as a treatment for epilepsy, but is now widely prescribed for a variety of chronic pain conditions. Its use in primary care as a treatment for chronic back and neck pain has risen by 535% in the last decade, despite little evidence of its effectiveness.

"The fact that anticonvulsants are often advertised to be effective for 'nerve pain' may mislead the prescriber to assume efficacy for low back pain or sciatica," Oliver Enke, MD, of the University of Sydney, told MedPage.

A 2018 study by Australian researchers found that gabapentinoids did not reduce back pain or disability and often had side effects such as drowsiness, dizziness and nausea. Another recent study found that combining gabapentin with opioid medication significantly raises the risk of dying from an overdose than opioid use alone.

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

The CDC’s opioid prescribing guideline recommends gabapentin as a safer alternative to opioids, without saying a word about its potential for abuse or side effects.

A 2017 commentary in the The New England Journal of Medicine warned that gabapentinoids -- a class of nerve medication that includes both gabapentin and pregabalin (Lyrica) -- are being overprescribed.

"We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” wrote Christopher Goodman, MD, and Allan Brett, MD. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain."

Can Gabapentin Improve Your Sex Life?

By Pat Anson, PNN Editor

Over the years the nerve drug gabapentin (Neurontin) has been used to treat a cornucopia of chronic pain conditions, from fibromyalgia and diabetic neuropathy to hot flashes and shingles.

Gabapentin is so widely prescribed that a Pfizer executive once called the drug “the snake oil of the twentieth century” because researchers found it successful in treating just about everything they studied.

Add sexual function to the list.

In a small study, researchers at Rutgers University found that gabapentin improved sexual desire, arousal and satisfaction in 89 women with provoked vulvodynia, a chronic condition characterized by stinging, burning and itching at the entry to the vagina. Vulvar pain often occurs during intercourse, which leads to loss of interest in sex.

The improvements in desire, arousal and sexual satisfaction were small, but considered “statistically significant” in research parlance. Gabapentin did not improve lubrication or orgasm.

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"Our theory was that reducing pelvic floor muscle pain might reduce vulvodynia pain overall and thus improve sexual function," said Gloria Bachmann, MD, director of the Women's Health Institute at Rutgers and lead author of the study published in the Journal of Obstetrics and Gynecology.

"We found that women with greater muscle pain responded better in terms of pain and improved arousal than those with less pain, which suggests that Gabapentin be considered for treatment in women who have significant muscle tightness and spasm in the pelvic region.”

Does this mean gabapentin is a female version of Viagra? Not necessarily, says Bachmann, who stressed that the study only focused on women with vulvodynia.

“We didn't research the question of gabapentin enhancing sexual function in all women,” Bachmann wrote in an email to PNN. “The decision to give gabapentin to a woman who reports chronic vulvar pain and sexual dysfunction would have to be made on an individual basis, depending on her medical history and the results of her physical and pelvic examination.

“From the data, it appears that women with increased muscle tenderness of the pelvic floor may be the group who benefit most from gabapentin.”

Sales of gabapentin have soared in recent years — not because it improves sexual satisfaction — but because it is seen as a safer pain reliever than opioid medication.

Patients prescribed gabapentin often complain of side effects such as mood swings, depression, dizziness, fatigue and drowsiness.  Drug abusers have also discovered that gabapentin can heighten the effects of heroin, cocaine and other illicit substances, and it is increasingly being abused.

Patients at Ohio Hospital Have Surgery Without Opioids

By Pat Anson, PNN Editor

Would you want to go through a major surgery without the use of opioid pain medication?

Patients at an Ohio hospital are getting acetaminophen, gabapentin and nonsteroidal anti-inflammatory drugs (NSAIDs) to manage their pain before and after colorectal operations – and their surgeons say the treatment results in better patient outcomes.

“Over 75 percent of our elective colorectal patients underwent surgery without requiring narcotic analgesics postoperatively, including after discharge,” says Sophia Horattas, MD, of Cleveland Clinic Akron General Hospital.  “During this time period our patient satisfaction scores improved as well as patients' perceptions of pain control.”

All eight general surgeons at Akron General adopted the non-opioid treatment protocol in 2016, applying it to patients who had elective colon operations. Prior to surgery, the patients were all educated about pain management, non-opioid analgesics, and the risks associated with opioids.

Researchers evaluated 155 of the patients and presented their findings this week at the American College of Surgeons Clinical Congress in Boston.

Overall, 83 percent (128) of the patients did not need opioid medication after their operations. Among those who did, use of opioids before surgery was often an indicator that they would want them again. Nine of the 15 patients who had prior experience with opioids used them again after surgery.

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Among the remaining 140 patients who did not use opioids before surgery, 85 percent (119) did not need opioid medication for pain relief.

The researchers found that patients who used opioid painkillers typically spent more time in the hospital; an average of 2.7 days vs. 2.3 days for the non-narcotic group.

“Patient education played a large role in protocol compliance, and patient satisfaction improved as they were able to avoid prolonged fasting, achieve improved pain control without the side effects of narcotic analgesia, and be discharged home earlier,” said Horrattas.

For pre-emptive analgesia before surgery, patients received one dose of acetaminophen, gabapentin, and the NSAID celecoxib (Celebrex).  In the operating room, patients received a nerve block and underwent anesthesia with the non-opioid pain relievers ketamine and lidocaine.   

Surgeons at Akron General have since adopted the non-opioid protocol for other major abdominal operations, such as bariatric procedures, gynecological and genital/urinary tract procedures, and liver and gall bladder operations.

“One of the great things about our protocol is its reproducibility.  Once we developed our program, we found that it could be standardized across departments with consistently reproducible results,” said Horattas.

Akron General’s protocol is similar to guidelines adopted by the American Pain Society (APS) for postoperative pain care. The APS also encourages the use of non-opioid medications such as acetaminophen, NSAIDs, gabapentin (Neurotin) and pregabalin (Lyrica).  

Akron General gets below average ratings for patient satisifaction from Hospital Compare, a Medicare survey that asks patients about their experiences during a recent hospital stay. The hospital received only two of a possible five stars, which places it in the bottom third of hospitals nationwide. Only 68% of Akron General’s patients said they would definitely recommend the hospital.

According to Healthgrades, 3 percent of the patients died after a colorectal surgery at Akron General, which is slightly below the national average for that procedure.

Opioid Addiction Rare After Surgery

In recent years, many hospitals have shifted away from routinely giving patients opioids during and after major surgeries -- even though it is rare for patients to become chronic opioid users.

A large Canadian study found that only 0.4% of elderly patients that were prescribed opioids while recovering from a heart, lung, colon, prostate or hysterectomy operation were still using them a year after their surgeries.

Another large study published this year in the British Medical Journal found similar results. Only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Long-term opioid use after dental surgeries is also rare. A recent study published in JAMA found that only 1.3% of teens and young adults who were given opioids after wisdom teeth removal were still being prescribed opioids months after their initial prescription.

The vast majority of patients still prefer opioids and perceive them as the most effective form of pain relief after surgery. In a recent survey of over 500 adults who were scheduled to have surgery, researchers at Thomas Jefferson University Hospital in Philadelphia found that 77% expected opioids, 37% expected acetaminophen, and 18% expected a NSAID for pain relief.

"Patients often assume they will receive opioids for pain, believing they are superior, and therefore may pressure physicians to prescribe them after surgery," said lead author Nirmal Shah, DO, an anesthesia resident at Thomas Jefferson University Hospital.

"But research shows opioids often aren't necessarily more effective. Clearly, we need to provide more education to bridge that gap and help patients understand that there are many options for pain relief after surgery, including other pain medications such as acetaminophen and ibuprofen."

Lyrica Not Effective for Treating Traumatic Nerve Pain

By Pat Anson, Editor

Pregabalin is not effective in relieving chronic pain caused by traumatic nerve injury, but it may be useful as an analgesic in treating pain after surgery, according to a new study published in the Journal of Neurology.

The placebo-controlled study followed 539 patients in North America, Europe, Africa and Asia for three months. About half had nerve pain after surgery, while the rest had nerve pain after an accident or trauma.

Researchers found that pregabalin was not an effective pain reliever for the patients with traumatic nerve injuries, but the drug did provide better pain relief than placebo for the surgery patients.

"While these finding show that pregabalin is not effective in controlling the long-term pain for traumatic injury, it may provide relief for patients (that) experience post-surgical pain," said lead author John Markman, MD, director of the Translational Pain Research Program in the University of Rochester Department of Neurosurgery.

"The possibility that there was pain relief for those patients who had a hernia repair, or breast surgery for cancer, or a joint replacement lays the groundwork for future studies in these post-surgical syndromes where there is so much need for non-opioid treatments."

Pregabalin, which is sold by Pfizer under the brand name Lyrica, is FDA-approved for the treatment of chronic pain associated with shingles, spinal cord injury, fibromyalgia, and diabetic peripheral neuropathy.

It is also commonly prescribed as an "off label" treatment for other types of chronic pain and as an alternative to opioid medication.

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A major challenge for doctors is that biological changes in nerves and other tissues while healing from surgery or trauma vary from one patient to the next. There is also no diagnostic method that allows doctors to identify which patients will respond to a particular type of pain treatment.

"Given the rising rates of surgery and shrinking reliance on opioids, it is critical that we understand how to study new drugs that work differently in patients like the ones included in this study," Markman added.

While critics often say there is little or no evidence to support the long-term use of opioids, the same is true for other types of pain medication, including pregabalin. Nevertheless, in its guideline for opioids, the Centers for Disease Control and Prevention recommends pregabalin and its chemical cousin gabapentin as alternatives for treating chronic pain – without even mentioning their side effects or potential for abuse.

Pregabalin and gabapentin belong to a class of nerve medication called gabapentinoids, which were originally developed to treat epilepsy, not pain. In recent, 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 use of pregabalin and gabapentin has tripled in the U.S. over the past decade, but health officials have only recently started looking into their misuse and abuse. While gabapentin has a warning label cautioning users who take the drug with opioids, there is no similar warning for pregabalin.

CDC: Most Overdoses Involve Illicit Opioids

By Pat Anson, Editor

The Centers for Disease Control and Prevention has released a new report further documenting the changing nature of the opioid crisis and the lesser role played by opioid pain medication in drug overdoses.

The report from the CDC’s Enhanced State Opioid Overdose Surveillance (ESOOS) program looked at nearly 12,000 opioid overdose deaths in 11 states from July 2016 to June 2017. 

Nearly 59 percent of the overdose deaths were attributed to illicit opioids like fentanyl and heroin, while 18.5% had both illicit and prescription opioids.

Less than 18% tested positive for prescription opioids only.

Many of the deaths involved someone with a criminal record or a history of substance abuse. Nearly one in ten overdose victims had been released from a prison or jail in the month preceding the overdose.

Evidence of injection drug use was found in about half of the illicit opioid deaths and about 15% had lived through a previous overdose.

OPIOID OVERDOSES (2016-2017)

Source: CDC Enhanced State Opioid Overdose Surveillance

There were also distinct differences in demographics between the illicit and prescription opioid overdoses. The average age of people who died from prescription opioids was 47, while the average age of those who died from illicit opioids was 36. Men were far more likely to overdose on an illicit opioid (73%), while more women (51%) died from a prescription opioid overdose.

“Findings from this analysis indicate that illicit opioids were a major driver of opioid deaths, especially among younger persons, and were detected in approximately three of four deaths overall. Prescription opioids were detected in approximately four of 10 deaths,” CDC researchers reported in the Morbidity and Mortality Weekly Report (MMWR).

Polysubstance Overdoses

Another key finding from the report was the frequent involvement of other drugs in opioid overdoses.

Benzodiazepines – a class of anti-anxiety medication that includes Xanax and Valium – were detected in over half of the prescription opioid deaths and in about one of every four illicit opioid deaths. “Benzos” depress the central nervous system and raise the risk of overdose when used with opioids. 

Gabapentin (Neurontin) – an anti-seizure drug widely prescribed off-label to treat pain -- was detected in over 21% of the prescription opioid deaths and in about 10% of the other overdoses.

“The combined use of gabapentin and opioids might be an indicator of high-risk opioid misuse and requires further study,” researchers said. “Extensive use of cocaine and benzodiazepines among deaths where both prescription and illicit opioids were detected highlights the need for prevention and treatment programs to address polysubstance use.”

Because so many drugs – both legal and illegal -- are often involved in overdoses, the CDC researchers cautioned that efforts to prevent opioid abuse “should not focus exclusively on one opioid type.”

That warning is at odds with the CDC’s own Rx Awareness program, an advertising campaign launched last year that focuses solely on the stories of people “whose lives were torn apart by prescription opioids.”

Fentanyl, heroin and other drugs commonly involved in overdoses are not addressed by the Rx Awareness campaign. 

“Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging,” the CDC explained when launching the campaign.

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Earlier this year, CDC researchers acknowledged that they overestimated the number of overdoses involving prescription opioids by combining them with deaths attributed to illicit fentanyl and other synthetic opioids. The ESOOS program was launched, in part, to correct that error.

ESOOS data is considered more reliable because it includes blood toxicology reports, as well as death certificates, medical examiner and coroner reports, death scene investigations, and an overdose victim’s history of substance abuse. A total of 32 states participate in ESOOS.

The 11 states participating in the current report include: Oklahoma, New Mexico, Maine, Massachusetts, New Hampshire, Rhode Island, Missouri, Ohio, West Virginia, Wisconsin and Kentucky.

Studies Warn of Pregabalin Deaths

By Pat Anson, Editor

Two new studies – one in Canada and one in Australia – should give pause to patients who use opioids and pregabalin (Lyrica), an anticonvulsant medication increasingly prescribed for fibromyalgia, neuropathy and other chronic pain conditions. Both studies found a number of overdose deaths that involve – but were not necessarily caused -- by pregabalin.

The Canadian study, published in the Annals of Internal Medicine, looked at over 1,400 patients in Ontario on opioid medication from 1997 to 2016 who died from opioid-related causes. Another group of over 5,000 surviving opioid patients was used as a control group.

Researchers found that patients who were co-prescribed opioids and pregabalin had a significantly higher risk of an overdose.

The risk of death was over two times higher for patients receiving opioids and a high dose of pregabalin (over 300mg) compared to those who took opioids alone.

Patients on a low or moderate dose of pregabalin also had a heightened risk, although not as large.

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Researchers say pregabalin has a sedative effect and may interact with opioids in ways that increase respiratory depression. Few doctors and patients are aware of the risk, even though over half of Ontario residents who begin pregabalin therapy are also prescribed an opioid.

"There is an important drug interaction between opioids and pregabalin that can lead to increased risk of fatal overdose, particularly at high doses of pregabalin," lead author Tara Gomes, PhD, of the Institute for Clinical Evaluative Sciences (ICES) and St. Michael's Hospital in Toronto, told MedPage Today.

"Clinicians should consider carefully whether to prescribe opioids and pregabalin together. If they decide that both medications are clinically appropriate, they should start with low doses and monitor their patients closely."

Lyrica (pregabalin) and Neurontin (gabapentin) are both made by Pfizer and belong to a class of anticonvulsant nerve medication called gabapentinoids. Sales of gabapentinoids have tripled in recent years, in part because of CDC prescribing guidelines that recommend the drugs as alternatives to opioid medication.  

U.S. health officials have only recently started looking into the misuse and abuse of gabapentinoids, which are increasingly used by addicts to enhance the euphoric effects of heroin and other illicit opioids. While gabapentin  has a warning label cautioning users who take the drug with opioids, there is no similar warning for pregabalin.

“Although current product monographs for gabapentin contain warnings about serious adverse events when this agent is combined with opioids, those for pregabalin do not. The importance of our finding warrants a revision of the pregabalin product monographs,” wrote Gomes.

Pregabalin Abuse in Australia

Health officials in Australia are also concerned about the growing use of pregabalin.  Researchers at the NSW Poisons Information Centre say poisoning cases involving pregabalin rose from zero in 2005 to 376 cases in 2016.

“Our study shows a clear correlation between the rapid and continuous rise of pregabalin dispensing and an increase in intentional poisonings and deaths associated with pregabalin,” said lead author Dr. Rose Cairns, a specialist at the NSW Poisons Information Centre.

According to the Australian Journal of Pharmacy (AJP), there have been 88 recorded deaths associated with pregabalin in recent years. Most of the deaths involved young, unemployed males who had a history of substance abuse, particularly with opioids, benzodiazepines, alcohol and illicit drugs.

“We believe that Australian doctors may not be aware of the abuse potential of pregabalin,” Cairns said. “Most patients who are prescribed this medication are in the older population but the group who are at high risk of overdosing are much younger. These people are likely to have been prescribed pregabalin despite having a history of substance abuse.”

According to researchers, up to two-thirds of people who intentionally misused pregabalin had a prior documented substance abuse history. “Prescribers need to consider this growing body of evidence that pregabalin has abuse potential before prescribing, especially to patients with substance abuse history,” said Cairns.

Pfizer did not respond to a request for comment on the Canadian and Australian studies.

Lyrica and Neurontin Ineffective for Low Back Pain

By Pat Anson, Editor

Lyrica, Neurontin and other anti-convulsant drugs are ineffective for treating low back pain and may even be harmful to patients, according to a new study published in the Canadian Medical Association Journal.

Prescriptions for anti-convulsant drugs have soared in recent years, as doctors seek “safer” alternatives to opioid pain medication.  Lyrica (pregabalin) and Neurontin (gabapentin) belong to a class of anti-convulsant nerve medications known as gabapentinoids. They are primarily used for treating nerve pain and fibromyalgia, but are increasingly being prescribed off-label to treat lower back and neck pain.

Australian researchers reviewed 9 placebo-controlled randomized trials and found high quality evidence that gabapentinoids did not reduce back pain or disability and often had side effects such as drowsiness, dizziness and nausea.

“The take-home message is that anti-convulsants are not effective and can lead to adverse effects in people with low back pain and radiating leg pain (eg, sciatica), so they should not be recommended to this patient population,” lead author Oliver Enke, MD, a researcher at the University of Sydney Medical School, told Helio Family Medicine.

Low back pain is the world’s leading cause of disability. Guidelines for treating low back pain usually recommend physical therapy, exercise and non-opioid pain relievers rather than stronger analgesics such as opioids or anti-convulsants.

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A 2017 study published in PLOS Medicine also warned that pregabalin and gabapentin were ineffective for low back pain and have a “significant risk of adverse effects.” 

PNN readers often complain about side effects from Lyrica and Neurontin.

“I have used both medicines and neither help with lower back pain for me,” said Sheri. “I will say the mental confusion and memory loss on Lyrica is very real, but it takes a slight edge of pain away in my body as a whole from the fibromyalgia.”

“I can vouch that Lyrica does not help with back pain,” said Debra. “It helped with the nerve pain but I thought I was literally losing my mind. I couldn't remember simple words or synonyms for words.”

“I've been taking gabapentin for almost six months; it has helped my peripheral neuropathy, but I still suffer every day from arthritis in every joint of my body, including my lower back,” another reader wrote.

Lyrica and Neurontin are both made by Pfizer and are two of the company’s top selling drugs, generating billions of dollars in sales annually. Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles, and spinal cord injuries.

Neurontin is approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but is also widely prescribed off-label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder. According to one estimate, over 90% of Neurontin sales are for off-label uses. About 68 million prescriptions were written for gabapentin in the U.S. last year, compared to 44 million in in 2013.

There have been increasing reports of gabapentinoids being abused by drug addicts, who have learned they can use the medications to heighten the high from heroin, marijuana, cocaine and other substances. Gabapentin is not currently scheduled as a controlled substance by the DEA, while pregabalin is classified as a Schedule V controlled substance, meaning it has a low potential for addiction and abuse.  

FDA Monitors Social Media for Drug Abuse Trends

By Pat Anson, Editor

A recent letter in The New England Journal of Medicine sheds some light on how the Food and Drug Administration tracks changing patterns of drug use on Facebook, Twitter and other social media.

The FDA began monitoring social media – what it calls “proactive pharmacovigilance” – about a decade ago, primarily as an early warning system for adverse events involving medication.

More recently, the agency has used active surveillance of social media to study the abuse of opioid painkillers and gabapentinoids, a class of nerve medication that includes gabapentin (Neurontin) and pregabalin (Lyrica). Gabapentinoids are increasingly being prescribed as “safer” alternatives to opioids.

“To understand why usage patterns are shifting, the FDA used a social media ‘listening platform’ to set up a dashboard to track traditional social media sites (such as Twitter, Facebook, Instagram, blogs, and forums) that we monitor for conversations about opioids,” explained FDA commissioner Scott Gottlieb, MD, and co-authors Douglas Throckmorton, MD, and Janet Woodcock, MD, two senior FDA officials.

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“When we find mention of additional substances on social media or elsewhere, we conduct more specific searches for relevant, publicly available conversations through our listening platform, as well as through Reddit, Google, and various online forums that don’t require registration or subscription. These may include forums associated with drug misuse or abuse, such as Bluelight.org and talk.drugabuse.com.”

What did the FDA learn about gabapentinoids on social media? Preliminary findings indicate the abuse of gabapentinoids isn’t widespread, but their use continues to increase, especially for gabapentin.

The FDA is also actively monitoring the social media sites of kratom vendors. As PNN reported last month, one vendor received a warning letter from the FDA for sharing on its Facebook page a CNN story about the herbal supplement as a possible treatment for pain and opioid addiction. The vendor only said the story was “positive news for kratom,” but the FDA said that amounted to the illegal marketing of an unapproved drug.

“The FDA thus faces challenges as we confront the opioid crisis and monitor changing patterns of use, abuse, and misuse of other products,” Gottlieb wrote. “The right approach to regulating these substances is best determined through a multifaceted system of pharmacovigilance, using various tools to mine traditional and new sources of epidemiologic data, assess products’ pharmacologic properties, and evaluate the social contexts in which substances are being used.”

To be clear, the FDA’s surveillance of social media isn’t very different from what private enterprise is already doing. NUVI, for example, provide social media monitoring to companies “to get real-time insights into what people are saying about your brand online.”  Companies also sell software that track keywords, hashtags and user profiles on social media. And PatientsLikeMe, the largest online patient network with over 600,000 members, sells some of its data to the FDA and healthcare industry.

At PNN, we do stories all the time about opioids, kratom, gabapentinoids and other drugs. Is Pain News Network under surveillance by the FDA? Are reader comments on our website and social media being monitored? We don’t know. But in an age of growing concern about Internet privacy and the sharing of personal data, we thought you should know that the answer could be yes.