Should Gabapentin Be a Controlled Substance?

By Pat Anson, Editor

The U.S. Drug Enforcement Administration should consider scheduling gabapentin (Neurontin) as a controlled substance, according to researchers who studied the recreational use of the drug in Kentucky.

Gabapentin is a nerve medication approved by the Food and Drug Administration to treat epilepsy and post-herpetic neuralgia (shingles), but it is also widely prescribed off-label to treat fibromyalgia, migraines, neuropathy and other chronic pain conditions. The Centers for Disease Control and Prevention even recommends gabapentin as a safer alternative to opioids.

Sales of gabapentin have soared in recent years. About 64 million prescriptions were written for gabapentin in the U.S. in 20l6, a 49% increase in just five years.

But drug abusers have also discovered that gabapentin can heighten the effects of heroin, marijuana, cocaine and other substances.

"People are looking for other drugs to substitute for opioids, and gabapentin has filled that place for some," said Rachel Vickers Smith, PhD, an assistant professor at the University of Louisville School of Nursing. “Some have said it gives them a high similar to opioids. It had been easy to get a prescription for gabapentin and it's very cheap."

Vickers Smith and her colleagues recruited 33 people from Appalachian Kentucky who used gabapentin recreationally and asked them about their drug use. Many reported they started taking gabapentin over 10 years earlier for a legitimate medical condition, such as pain and anxiety. Over time, they started using the drug to help them relax, sleep and get high.

“Focus group responses highlighted the low cost of gabapentin for the purpose of getting high and noted increasing popularity in the community, particularly over the last 2 years. Gabapentin was a prominent drug of abuse in two cohorts of the primarily opioid-using individuals. Providers should be aware of gabapentin’s abuse potential, and a reexamination of the need for scheduling is warranted,” researchers reported in the journal Psychology of Addictive Behaviors.

In 2017, Kentucky became the first state to classify gabapentin as a controlled substance, which makes it more difficult for the medication to be prescribed. Ohio’s Substance Abuse Monitoring Network also issued an alert warning of gabapentin misuse across the state.

‘Snake Oil of the 20th Century’

Gabapentin was first approved by the FDA in 1993 and sold by Pfizer under the brand name Neurontin. A few years later, it was so widely prescribed that a top Pfizer executive called gabapentin “the snake oil of the twentieth century” in an email. The company was later fined hundreds of millions of dollars for promoting Neurontin’s off-label use.

"Early on, it was assumed to have no abuse potential," says Vickers Smith. "There's a need to examine it in further detail, especially if prescribing it is going to be encouraged."

Federal health officials have only recently started looking into the misuse and abuse of gabapentinoids, a class of nerve medication that includes gabapentin and pregabalin (Lyrica).

"Our preliminary findings show that abuse of gabapentinoids doesn't yet appear to be widespread, but use continues to increase, especially for gabapentin," FDA commissioner Scott Gottlieb, MD, said last week at a conference on opioid prescribing. "We're concerned that abuse and misuse of these drugs may result in serious adverse events such as respiratory depression and death. We want to understand changes in how patients are using these medications."

Gottlieb said FDA investigators are looking at websites and social media where opioid users discuss their use of gabapentinoids.

"We know we need to investigate and respond to signs of abuse as soon as signals emerge. We need to get ahead of these problems," he said.

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 a low potential for addiction and abuse.  

Lyrica and Neurontin Use Triples

By Pat Anson, Editor

The use of gabapentin (Neurontin) and pregabalin (Lyrica) has soared in the United States, with little attention paid to their safety and effectiveness, according to a research letter published in JAMA Internal Medicine.

Gabapentin and pregabalin belong to a class of nerve medication known as gabapentinoids, which are increasingly prescribed as alternatives to opioids in treating neuropathy, fibromyalgia and other types of chronic pain.

In an analysis of health data for nearly 350,000 patients, researchers found that the use of gabapentinoids more than tripled in the past decade, from 1.2% of patients in 2002 to 3.9% in 2015.

Use of the drugs was concentrated in older patients with numerous other health problems, who were often co-prescribed opioids or benzodiazepines, a class of anti-anxiety medication.

“The combination of a dearth of long-term safety data, small effect sizes, concern for increased risk of overdose in combination with opioid use, and high rates of off-label prescribing, which are associated with high rates of adverse effects, raises concern about the levels of gabapentinoid use,” wrote lead researcher Michael Johansen, MD, of OhioHealth, a large non-profit health system based in Ohio.

“While individual clinical scenarios can be challenging, caution should be advised in the use of gabapentinoids, particularly for those individuals who are long-term opioid users, given the lack of proven long-term efficacy and the known and unknown risks of gabapentinoid use.”

JAMA INTERNAL MEDICINE

Johansen’s research adds to a growing body of evidence that pregabalin and gabapentin are overprescribed and being abused. A recent study by Canadian researchers found that there was “no clear rationale” for the off-label use of the drugs and warned that they have a “significant risk of adverse effects” such as dizziness, fatigue and diminished mental activity.

Lyrica (pregabalin) and Neurontin (gabapentin) are both made by Pfizer and are two of the company’s top selling drugs, generating billions of dollars in annual sales. Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries; while Neurontin is approved to treat epilepsy and post-herpetic neuralgia. Both drugs are also widely prescribed off label to treat back pain, depression, migraine and other conditions.

Sales of pregabalin and gabapentin have risen steadily in recent years, in part because of CDC prescribing guidelines that recommend the two drugs as alternatives to opioid pain medication. About 64 million prescriptions were written for gabapentin in the U.S. in 20l6, a 49% increase in just five years.

“We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” Christopher Goodman, MD, and Allan Brett, MD, recently wrote in a commentary published in The New England Journal of Medicine. “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.

Gabapentinoids are increasingly being used recreationally by addicts who have found the medications enhance the effects of heroin and other opioids. Lyrica and Neurontin have been linked to heroin overdoses in the United Kingdom, where prescriptions for both drugs have soared in recent years. 

Painkillers Raise Risk of Obesity and Hypertension

By Pat Anson, Editor

Commonly prescribed painkillers such as opioids and gabapentinoids  -- a class of pain medication that includes Lyrica and Neurontin – significantly raise the risk of obesity and high blood pressure, according to a large new study published in PLOS ONE.

British researchers analyzed health data on over 133,000 people, comparing the Body Mass Index (BMI), waist circumference, blood pressure and sleeping habits of patients taking pain relievers to those who did not. The study is believed to be the largest to look at the effects of painkillers on overall health.

“In the last two decades there has been a significant increase in the number of people being prescribed both opioid and non-opioid medications to treat chronic pain,” said lead author Sophie Cassidy, PhD,  a research associate at the Institute of Cellular Medicine, Newcastle University. “We already know that opiates are dependency-forming but this study also found patients taking opiates have the worst health. Obesity rates are much higher and the patients reported sleeping poorly.”

Those taking opioids were 95% more likely to be obese, 82% more like to have a “very high” waist circumference and 63% more likely to have hypertension compared to the control group.  

“There could be a number of possible mechanisms by which opioids might be associated with weight gain. Sedation might decrease physical activity and therefore reduce energy expenditure, those in our cohort taking opiates were less active, and those taking both opiates and other sedative drugs were the least active. Opioids have also been shown to alter taste perception with a craving for sugar and sweet foods described,” Cassidy wrote.

“These results add further weight to calls for these chronic pain medications to be prescribed for shorter periods.”

Patients who took gabapentinoids were also more likely to be obese, have a bigger waist and higher blood pressure compared to those not taking the drugs.

Gabapentinoids are commonly prescribed as alternatives to opioids to treat neuropathy, shingles and fibromyalgia, although many patients complain about side effects such as weight gain, depression and anxiety.

As PNN has reported, gabapentinoids are also coming under scrutiny because they are increasingly being abused. Lyrica (pregabalin) and Neurontin (gabapentin) are being reclassified as controlled “Class C” substances in the UK, following a spike in the number of deaths involving the medications.

Last week, the West Virginia Board of Pharmacy designated gabapentin as a “drug of concern,” after overdoses in the state involving gabapentin rose from 36 deaths in 2012 to 106 in 2016.  Ohio, Pennsylvania and Kentucky have also reported increases in fatal overdoses involving gabapentin.

Gabapentin Raises Risk of Opioid Overdose

By Pat Anson, Editor

Another study is raising questions about the safety of the anti-seizure drug gabapentin, especially when it’s taken with opioid pain medication.

According to research published online in PLOS Medicine, combining gabapentin with opioid painkillers is associated with a significantly higher risk of dying from an opioid overdose than opioid use alone.

"Clinicians should consider carefully whether to continue prescribing this combination of products, and when deemed necessary, should closely monitor their patients and adjust opioid dose accordingly," wrote lead author Tara Gomes, PhD, principal investigator for the Ontario Drug Policy Research Network and an assistant professor at the University of Toronto.

Gomes and her colleagues analyzed data from 1,256 people in Ontario, Canada who died from opioid-related causes, and compared them with a control group of 4,619 people who also used opioid medication, but did not die of an opioid-related cause.

Overall, 12.3% of the people who died and 6.8% in the control group were prescribed gabapentin in the prior 120 days. After adjusting for additional risk factors, the researchers estimated that the combination of gabapentin and opioids was associated with a 49% higher risk of dying from an opioid overdose.

Although gabapentin is an anticonvulsant originally developed as a treatment for epilepsy, it is now widely prescribed for neuropathy and other chronic pain conditions, sometimes in combination with opioids.

Until now, no previous study had examined the risks of using gabapentin and opioid medication simultaneously, even though both are known to cause respiratory depression that can lead to an overdose.

“Our study has important implications for public health, particularly given the high degree of co-prescription. Almost 10% of patients treated with an opioid in our study also used gabapentin, while nearly half of patients treated with gabapentin were co-prescribed opioids,” said Gomes.

“Gabapentin is frequently used as an adjunct to opioids for neuropathic pain syndromes, but physicians may not be aware of the potential for respiratory depression with this drug; thus, increased awareness among patients and clinicians about the potential for a life-threatening interaction between these drugs is essential.”

The researchers believe pregabalin, an anticonvulsant that acts similarly to gabapentin, may also raise the risk of overdose when taken with opioids. But they were unable to test their theory because of the limited use of pregabalin during the study period.

Both pregabalin and gabapentin are produced by Pfizer -- under the brand names Lyrica and Neurontin -- and are two of its top selling drugs. Pfizer did not respond to a request for comment on the Canadian study.

A previous study linked pregabalin and gabapentin to an uptick in opioid overdoses in England and Wales. Some addicts believe the drugs can boost the “high” they get from heroin and other illicit substances.

Gabapentin is approved by the FDA to treat epilepsy and neuropathic pain caused by shingles. It is also prescribed “off-label” for depression, migraine, fibromyalgia and bipolar disorder. About 64 million prescriptions were written for gabapentin in the U.S. in 2016, a 49% increase since 2011.

Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, epilepsy, post-herpetic neuralgia caused by shingles and spinal cord injury. It is also prescribed off label to treat a variety of other conditions.

The CDC’s opioid prescribing guidelines recommend both pregabalin and gabapentin as alternatives to opioids, without saying a word about their potential for abuse or side effects. Pfizer has signed agreements with local prosecutors in Chicago and Santa Clara County, California to support the CDC guidelines and withdraw funding from patient advocacy groups and non-profits that question their validity.   

A recent commentary in the The New England Journal of Medicine warned that gabapentinoids -- the class of medication that Neurontin and Lyrica belong to -- 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."

Lyrica and Neurontin Face More Scrutiny

By Pat Anson, Editor

The safety and effectiveness of Lyrica (pregabalin) and Neurontin (gabapentin) – two non-opioid drugs widely used to treat chronic pain – are drawing new scrutiny from researchers and doctors who believe the medications are over-prescribed.

In a study published in PLOS Medicine, Canadian researchers say there is little evidence that gabapentinoids – a class of nerve medication that includes Neurontin and Lyrica – are effective in treating chronic low back pain. In their review of 8 clinical studies, the researchers also found the drugs have a “significant risk of adverse effects.”

Lyrica and Neurontin are commonly prescribed for fibromyalgia and neuropathic pain, but the researchers say the drugs are increasingly prescribed for chronic back pain, even though there is “no clear rationale” for it.

"Despite their widespread use, our systematic review with meta-analysis found that there are very few randomized controlled trials that have attempted to assess the benefit of using gabapentin or pregabalin in patients of chronic low back pain," wrote lead author Harsha Shanthanna, MD, an assistant professor at McMaster University in Hamilton, Ontario.

"They necessitate prolonged use and are associated with adverse effects and increased costs. Recent guidelines from the National Health Service (NHS), England, expressed concerns on their off-label use, in addition to the risk of misuse.”

Shanthanna and his colleagues found that gabapentin showed “minimal improvement” in back pain compared to a placebo and pregabalin was “inferior” compared to other analgesics. There were no deaths or hospitalizations reported in any of the studies, but both drugs were associated with increased risk of dizziness, fatigue, visual disturbances, and diminished mental activity.

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. It is also prescribed off-label to treat other chronic pain conditions, including lower back pain.

Neurontin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but is 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. Pfizer has paid $945 million in fines to resolve criminal and civil charges that it marketed Neurontin off-label to treat conditions it was not approved for.

Sales of pregabalin and gabapentin have risen steadily in recent years, in part because of CDC prescribing guidelines that recommend the two drugs as alternatives to opioid pain medication. About 64 million prescriptions were written for gabapentin in the U.S. last year, a 49% increase since 2011.

“We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” Christopher Goodman, MD, and Allan Brett, MD, recently wrote in a commentary published in The New England Journal of Medicine. “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.

“Patients who are in pain deserve empathy, understanding, time, and attention. We believe some of them may benefit from a therapeutic trial of gabapentin or pregabalin for off-label indications, and we support robust efforts to limit opioid prescribing. Nevertheless, clinicians shouldn’t assume that gabapentinoids are an effective approach for most pain syndromes or a routinely appropriate substitute for opioids.”

FDA Seeks Public Comment on Abuse of Lyrica

The U.S. Food and Drug Administration announced last week that it was seeking public comment on reports that pregabalin is being abused. The FDA action was in response to a formal notification from the World Health Organization (WHO) that it may place international restrictions on pregabalin to reduce the risk of abuse and diversion. The FDA has until September 30 to respond to WHO.

“Reports indicate that patients are self-administering higher than recommended doses to achieve euphoria, especially patients who have a history of substance abuse, particularly opioids, and psychiatric illness. While effects of excessively high doses are generally non-lethal, gabapentinoids such as pregabalin are increasingly being identified in post-mortem toxicology analyses,” the FDA said in a notice published in the Federal Register.

Pregabalin is already classified as Schedule V controlled substance in the U.S. under the Controlled Substances Act, which means the DEA considers it to have a low potential for abuse.

The idea that Lyrica and Neurontin are being abused is surprising to many patients and doctors, but there are growing signs the drugs are being used recreationally.

Both Lyrica and Neurontin have been linked to heroin overdoses in England and Wales, where prescriptions for both drugs have soared in recent years.  Addicts have apparently found the medications enhance the effects of heroin and other opioids.

A small study of urine samples from patients being treated at U.S. pain clinics and addiction treatment centers found that one in five patients were taking gabapentin without a prescription.

Gabapentin and pregabalin are also being abused by prison inmates, according to Jeffrey Keller, MD, chief medical officer of Centurion, a private corrections company. 

“Gabapentin is the single biggest problem drug of abuse in many correctional systems,” Keller recently wrote in Corrections.com. “There is little difference (in my opinion) between Lyrica and gabapentin in both use for neuropathic pain or for abuse potential.”

Pfizer did not respond to a request for comment.

Pfizer Agrees to Support CDC Opioid Guideline

By Pat Anson, Editor

Since its release in March 2016, the CDC’s opioid prescribing guideline has had a chilling effect on chronic pain patients, as doctors, regulators, states and insurance companies have adopted the CDC’s "voluntary" recommendations as policies or even law.

As a result, it has become harder for many pain patients to get opioids prescribed or even find a doctor willing to treat them. We have tried to keep you informed and aware of these facts.

Now one of the world’s largest drug makers has agreed to not make any statements that conflict with the CDC guideline and to withdraw support for any organizations that challenge it. Pain News Network is among them.

In an agreement signed last month with the Santa Clara County, California Counsel’s Office, Pfizer promised to abide by strict standards in its marketing of opioids and to “not make or disseminate claims that are contrary to the ‘Recommendations’ of the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain.”

That voluntary guideline discourages primary care physicians from prescribing opioids for chronic pain, but has been widely implemented by many doctors, regardless of specialty.

Pfizer also agreed to stop funding patient advocacy groups, healthcare organizations or any charities that make “misleading statements” about opioids that are contrary to the CDC guidelines. Pfizer notified Pain News Network by email today that it was rescinding a $10,000 charitable grant awarded to PNN. Pfizer had sponsored PNN’s newsletter for the past year.  

"Kindly note Pfizer recently entered into an agreement with Santa Clara County, California that places limits on Pfizer’s ability to provide opioids-related funding to outside organizations.  After careful consideration, we regret to inform you that we are unable to support your request and must rescind the previous approval notification," the email said.

“This agreement is an important step in ensuring that doctors and patients in California receive accurate information about the risks and benefits of these highly addictive painkillers,” Santa Clara County Counsel James Williams said in a press release. “Such information is essential to curbing — and ultimately ending — the opioid epidemic plaguing Santa Clara County, the State of California, and many parts of the country.”

Santa Clara County was not pursuing any legal action against Pfizer, although it had filed a lawsuit against Purdue Pharma and four other opioid manufacturers, alleging that they falsely downplayed the risks of opioid painkillers and exaggerated their benefits.

“We applaud Pfizer’s willingness to work with us to combat the dramatic rise in opioid misuse, abuse, and addiction in California and the corresponding rise in overdose deaths, hospitalizations, and crime,” said Danny Chou, an Assistant County Counsel for the County of Santa Clara. “Pfizer has set a stringent standard that we expect all other opioid manufacturers to meet.”

Opioids make up only a tiny part of Pfizer’s business. The company sells just one opioid painkiller, an extended release and little known pain medication called Embeda.

As part of its agreement with Santa Clara County, Pfizer promised not to market opioids off-label for conditions they are not approved for and said it would “make clear” in its marketing that there are no studies supporting the use of opioids long-term for pain relief. Pfizer signed a nearly identical agreement with the city of Chicago last year to avoid litigation.

Interestingly, the CDC guideline suggests the use of gabapentin and pregabalin as alternatives to opioids for treating pain. Pfizer makes billions of dollars annually selling both of those drugs, under the brand names Neurontin and Lyrica.

In recent years, Pfizer has paid $945 million in fines to resolve criminal and civil charges that it marketed Neurontin off-label to treat conditions it was not approved for. Neurontin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but it is 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.

Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries. Lyrica is also prescribed off-label to treat a wide variety of other chronic pain conditions, including lumbar spinal stenosis, the most common type of lower back pain in older adults.

Gabapentin Boosts High For Opioid Abusers

By Carmen Heredia Rodriguez, Kaiser Health News

ATHENS, Ohio — On April 5, Ciera Smith sat in a car parked on the gravel driveway of the Rural Women’s Recovery Program here with a choice to make: go to jail or enter treatment for her addiction.

Smith, 22, started abusing drugs when she was 18, enticed by the “good time” she and her friends found in smoking marijuana.

She later turned to addictive painkillers, then anti-anxiety medications such as Xanax and eventually Suboxone, a narcotic often used to replace opioids when treating addiction.

Before stepping out of the car, she decided she needed one more high before treatment. She reached into her purse and then swallowed a handful of gabapentin pills.

CIERA SMITH (KAISER HEALTH NEWS)

Last December, Ohio’s Board of Pharmacy began reporting sales of gabapentin prescriptions in its regular monitoring of controlled substances. The drug, which is not an opioid nor designated a controlled substance by federal authorities, is used to treat nerve pain. But the board found that it was the most prescribed medication on its list that month, surpassing oxycodone by more than 9 million doses. In February, the Ohio Substance Abuse Monitoring Network issued an alert regarding increasing misuse across the state.

And it’s not just in Ohio. Gabapentin’s ability to tackle multiple ailments has helped make it one of the most popular medications in the U.S. In May, it was the fifth-most prescribed drug in the nation, according to GoodRx.

Gabapentin is approved by the Food and Drug Administration to treat epilepsy and pain related to nerve damage, called neuropathy. Also known by its brand name, Neurontin, the drug acts as a sedative. It is widely considered non-addictive and touted by the federal Centers for Disease Control and Prevention as an alternative intervention to opiates for chronic pain. Generally, doctors prescribe no more than 1,800 to 2,400 milligrams of gabapentin per day, according to information on the Mayo Clinic’s website.

Gabapentin does not carry the same risk of lethal overdoses as opioids, but drug experts say the effects of using gabapentin for long periods of time or in very high quantities, particularly among sensitive populations like pregnant women, are not well-known.

As providers dole out the drug in mass quantities for conditions such as restless legs syndrome and alcoholism, it is being subverted to a drug of abuse. Gabapentin can enhance the euphoria caused by an opioid and stave off drug withdrawals. In addition, it can bypass the blocking effects of medications used for addiction treatment, enabling patients to get high while in recovery.

Athens, home to Ohio University, lies in the southeastern corner of the state, which has been ravaged by the opioid epidemic. Despite experience in combating illicit drug use, law enforcement officials and drug counselors say the addition of gabapentin adds a new obstacle.

“I don’t know if we have a clear picture of the risk,” said Joe Gay, executive director of Health Recovery Services, a network of substance abuse recovery centers headquartered in Athens.

‘Available To Be Abused’

A literature review published in 2016 in the journal Addiction found about a fifth of those who abuse opiates misuse gabapentin. A separate 2015 study of adults in Appalachian Kentucky who abused opiates found 15 percent of participants also misused gabapentin in the past six months “to get high.”

In the same year, the drug was involved in 109 overdose deaths in West Virginia, the Charleston Gazette-Mail reported.

Rachel Quivey, an Athens pharmacist, said she noticed signs of gabapentin misuse half a decade ago when patients began picking up the drug several days before their prescription ran out.

“Gabapentin is so readily available,” she said. “That, in my opinion, is where a lot of that danger is. It’s available to be abused.”

In May, Quivey’s pharmacy filled roughly 33 prescriptions of gabapentin per week, dispensing 90 to 120 pills for each client.

For customers who arrive with scripts demanding a high dosage of the drug, Quivey sometimes calls the doctor to discuss her concerns. But many of them aren’t aware of gabapentin misuse, she said.

Even as gabapentin gets restocked regularly on Quivey’s shelves, the drug’s presence is increasing on the streets of Athens. A 300-milligram pill sells for as little as 75 cents.

(kAISER HEALTH NEWS)

Yet, according to Chuck Haegele, field supervisor for the Major Crimes Unit at the Athens City Police Department, law enforcement can do little to stop its spread. That’s because gabapentin is not categorized as a controlled substance. That designation places restrictions on who can possess and dispense the drug.

“There’s really not much we can do at this point,” he said. “If it’s not controlled … it’s not illegal for somebody that’s not prescribed it to possess it.”

Haegele said he heard about the drug less than three months ago when an officer accidentally received a text message from someone offering to sell it. The police force, he said, is still trying to assess the threat of gabapentin.

Little Testing

Nearly anyone arrested and found to struggle with addiction in Athens is given the option to go through a drug court program to get treatment. But officials said that some exploit the absence of routine exams for gabapentin to get high while testing clean.

Brice Johnson, a probation officer at Athens County Municipal Court, said participants in the municipal court’s Substance Abuse Mentally Ill Program undergo gabapentin testing only when abuse is suspected. Screenings are not regularly done on every client because abuse has not been a concern and the testing adds expense, he said.

The rehab program run through the county prosecutor’s office, called Fresh Start, does test for gabapentin. Its latest round of screenings detected the drug in five of its roughly 238 active participants, prosecutor Keller Blackburn said.

Linda Holley, a clinical supervisor at an Athens outpatient program run by the Health Recovery Services, said she suspects at least half of her clients on Suboxone treatment abuse gabapentin. But the center can’t afford to regularly test every participant.

Holley said she sees clients who are prescribed gabapentin but, due to health privacy laws, she can’t share their status as a person in recovery to an outside provider without written consent. The restrictions give clients in recovery an opportunity to get high using drugs they legally obtained and still pass a drug test.

“With the gabapentin, I wish there were more we could do, but our hands are tied,” she said. “We can’t do anything but educate the client and discourage” them from using such medications.

A stone painted with the phrase “Perfect Imperfection” is among the inspirational messages along the sidewalk leading to the main entrance of the Rural Women’s Recovery Program. (Carmen Heredia Rodriguez/KHN)

Smith visited two separate doctors to secure a prescription. As she rotated through drug court, Narcotics Anonymous meetings, jail for relapsing on cocaine and house arrest enforced with an ankle bracelet, she said her gabapentin abuse wasn’t detected until she arrived at the residential recovery center.

Today, Smith sticks to the recovery process. Expecting a baby in early July, her successful completion of the program not only means sobriety but the opportunity to restore custody of her eldest daughter and raise her children.

She intends to relocate her family away from friends and routines that helped lead her to addiction and said she will help guide her daughter away from making similar mistakes.

“All I can do is be there and give her the knowledge that I can about addiction,” Smith said, “and hope that she chooses to go on the right path.”

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

WHO Lists Fentanyl as ‘Essential Medicine’

By Pat Anson, Editor

At a time when hundreds – perhaps thousands – of Americans and Canadians are dying every month from overdoses of illicit fentanyl mixed with heroin or turned into counterfeit painkillers, it’s easy to lose sight of the fact that prescription fentanyl is an important and useful analgesic.  

We were reminded of that today by the World Health Organization (WHO), which added fentanyl skin patches and methadone to its list of essential medicines for treating cancer pain. WHO’s Essential Medicine List is not widely followed in developed countries – where prescription drugs are widely available – but it is used in many third world countries to guide decision making and increase access to medicines that are often in short supply.

"Safe and effective medicines are an essential part of any health system," said Dr. Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation. "Making sure all people can access the medicines they need, when and where they need them, is vital to countries’ progress towards universal health coverage."

Fentanyl patches and methadone are two of the 30 drugs being added to the Essential Medicine List, raising the total to 433 medicines considered vital in addressing public health needs. WHO also added drugs for treating HIV, hepatitis C, tuberculosis and leukemia; and gave new advice about the use of antibiotics.

While illicit, black market fentanyl has become a deadly scourge across the U.S. and Canada, prescription fentanyl is legally available in patches, lozenges and sprays to treat severe pain.  

WHO’s inclusion of fentanyl patches and methadone on the essential list is limited to the treatment of cancer pain. An expert panel that reviewed the medicines noted “there is a need for additional opioid treatment options” for cancer pain. About a third of cancer patients worldwide are undertreated for pain, and patients living in low or middle income countries often have limited access to opioid painkillers.  

Other opioids already on the essential list (for treating pain and palliative care) are codeine, morphine, hydromorphone and oxycodone . Aspirin, ibuprofen and paracetamol (acetaminophen) are on it too, although the latter is “not recommended for anti-inflammatory use due to lack of proven benefit.”

Gabapentin Rejected

It’s also worth noting the medications that did not make the updated WHO list. Tramadol was not approved as a treatment for cancer pain, while gabapentin (Neurontin) was rejected as a treatment for neuropathic pain.

WHO’s expert panel gave a scathing review of the application made by the International Association for the Study of Pain and the International Association of Hospice and Palliative Care for the inclusion of gabapentin; noting there were many cases of bias and data manipulation in the clinical studies used to support it. Also noted was the $430 million fine paid by Pfizer in 2004 to settle civil and criminal charges for a “marketing scheme” to promote Neurontin for unapproved uses.    

“The Committee acknowledged the serious issues on publication and outcome reporting bias as important ones,” the panel said. “The Expert Committee considered the uncertainty in efficacy estimates as a result of publication and outcome reporting biases in the currently available evidence for gabapentin. The Committee did not recommend inclusion of gabapentin on the EML (Essential Medicine List) for neuropathic pain on the basis of its uncertain benefits.”

While gabapentin is approved for neuropathic pain in the European Union and Australia, it is only approved for epilepsy and neuropathic pain caused by shingles in the U.S. Despite that limitation, gabapentin is widely prescribed “off label” to treat depression, anxiety, migraine, fibromyalgia and other chronic pain conditions.  About 64 million prescriptions were written in the U.S. for gabapentin in 2016, a 49% increase since 2011.

Lyrica and Neurontin Linked to Opioid Overdoses

By Pat Anson, Editor

British researchers say two drugs commonly prescribed as alternatives for opioid pain medication are linked to a rising number of heroin overdose deaths in England and Wales.

Pregabalin and gabapentin belong to a class of nerve medications known as gabapentoids. They were originally developed to treat epileptic seizures, but are increasingly prescribed to treat neuropathy, fibromyalgia and other chronic pain conditions. The drugs are sold by Pfizer under the brand names Lyrica (pregabalin) and Neurontin (gabapentin).

Researchers at the University of Bristol reported in the journal Addiction that opioid overdose deaths in England and Wales involving gabapentoids increased from less than one per year prior to 2009 to 137 deaths in 2015. The increase coincided with a surge in pregabalin and gabapentin prescribing in Wales and England, from one million prescriptions in 2004 to over 10 million in 2015.   

Researchers say the increased prescribing has made the drugs easier to obtain and abuse, and addicts have found they enhance the effects of heroin. Experiments on laboratory mice found that pregabalin slows respiratory depression, increasing the risk of an opioid overdose.

"It is important that doctors and people dependent on opioids are aware that the number of overdose deaths involving the combination of opioids with gabapentin or pregabalin has increased substantially and that there is evidence now that their concomitant use - either through co-prescription or diversion of prescriptions - increases the risk of acute overdose deaths,” said Matthew Hickman, a Professor of Public Health and Epidemiology in the University of Bristol's School of Social and Community Medicine.

The idea that Lyrica and Neurontin are being abused may be surprising to many patients and doctors, but the drugs are increasingly being used by addicts. In a small 2016 study of urine samples from patients being treated at pain clinics and addiction treatment centers, over one in five patients were found to be taking gabapentin without a prescription.

“The high rate of misuse of this medication is surprising and it is also a wakeup call for prescribers. Doctors don’t usually screen for gabapentin abuse,” said Poluru Reddy, PhD, medical director of ARIA Diagnostics in Indianapolis. “These findings reveal that there is a growing risk of abuse and a need for more robust testing.”

High Risk of Abuse in Prisons

Gabapentin and pregabalin are also being abused by inmates. Jeffrey Keller, MD, chief medical officer of Centurion, a private correctional company, says both drugs have a high abuse potential.  

“Gabapentin is the single biggest problem drug of abuse in many correctional systems,” Keller recently wrote in Corrections.com. “There is little difference (in my opinion) between Lyrica and gabapentin in both use for neuropathic pain or for abuse potential.”

Why would someone be so desperate to abuse them?

“If you are addicted, or even if you just like to get high once in a while, and you can’t obtain your preferred drugs of abuse because you are incarcerated, these are the drugs that can serve as an alternative in a pinch,” Keller wrote.
“It is critically important for medical professionals in corrections to know which seemingly benign drugs have the potential to be abused and diverted. Even if a particular inmate doesn’t care about getting high himself, he can still profit by selling these drugs to others who are. Vulnerable inmates can be (and are) bullied into obtaining these drugs for distribution.”

Gabapentin is approved by the FDA to treat epilepsy and neuropathic pain caused by shingles. It is also prescribed “off-label” for depression, migraine, fibromyalgia and bipolar disorder. About 64 million prescriptions were written for gabapentin in the U.S. in 2016, a 49% increase since 2011. Gabapentin is not scheduled by the DEA as a controlled substance.

Pregabalin is a Schedule V controlled substance, which means the DEA considers it to have a low abuse potential. Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, epilepsy, post-herpetic neuralgia caused by shingles and spinal cord injury. It is also prescribed off label to treat a variety of other conditions. Lyrica is Pfizer’s top selling drug, generates over $5 billion in annual sales, and is approved for use in over 130 countries.

The CDC’s opioid prescribing guidelines recommend both pregabalin and gabapentin as alternatives for opioids, without saying a word about their potential for abuse or side effects.

“Selected anticonvulsants such as pregabalin and gabapentin can improve pain in diabetic neuropathy and post-herpetic neuralgia. Pregabalin, gabapentin, and carbamazepine are FDA-approved for treatment of certain neuropathic pain conditions, and pregabalin is FDA approved for fibromyalgia management,” the guidelines state.

Hydrocodone Prescriptions Continue Falling

By Pat Anson, Editor

For the fifth year in a row, fewer prescriptions for the opioid painkiller hydrocodone were dispensed in the U.S. in 2016, according to a new report by the QuintilesIMS Institute, which tracks prescription drug use and spending.

The report adds further evidence that the nation’s overdose epidemic is being fueled by illegal opioids such as heroin and illicit fentanyl, not prescription painkillers.

About 7 million fewer prescriptions were filled last year for hydrocodone, which is usually combined with acetaminophen in Vicodin, Lortab, Lorcet, Norco, and other hydrocodone combination products.

As recently as 2012, hydrocodone was the #1 most widely dispensed medication in the nation, with 136 million prescriptions filled. Since then, hydrocodone prescriptions have fallen by over a third, to 90 million prescriptions.

Hydrocodone now ranks fourth, behind the thyroid drug levothyroxine (Synthroid), the blood pressure medication lisinopril (Zestril), and the statin atorvastatin (Lipitor).

Hydrocodone was reclassified by the DEA as a Schedule II controlled substance in 2014, making it harder to obtain. Opioid guidelines released last year by the CDC also probably had an impact, although hydrocodone prescriptions were falling long before the CDC and DEA acted.

HYDROCODONE PRESCRIPTIONS IN U.S. (MILLIONS)

• Population

• Population

Source: QuintilesIMS Institute

Prescriptions for hydrocodone and other opioids are likely to fall even further in 2017, because the DEA plans to reduce the supply of almost every Schedule II opioid pain medication by 25 percent or more "to prevent diversion." The 2017 quota for hydrocodone is being reduced by a third, to 58.4 million prescriptions, which the DEA considers an adequate supply.

Overall, QuintilesIMS reported 13 million fewer prescriptions for pain medicines in 2016, “as restrictions on prescribing and dispensing become increasingly common and impactful.” The company includes both narcotic and non-narcotic treatments in its pain medicine category.

Over 7 million more prescriptions were written last year for gabapentin (Neurontin), a medication originally developed to treat seizures that is now widely prescribed for neuropathy and other chronic pain conditions.  About 64 million prescriptions were written for gabapentin in 2016, a 49% increase since 2011.

More prescriptions are also being written for ibuprofen, a widely used pain reliever available both by prescription and in over-the-counter drugs. About 44 million prescriptions were filled for ibuprofen in 2016, a 19% increase since 2012.

The shift in prescribing away from opioids is hardly a surprise to pain sufferers. According to a recent survey of over 3,100 patients by PNN and the International Pain Foundation, over 70% said they were no longer prescribed opioids or were getting a lower dose since the CDC guidelines were released. About half of the doctors and pharmacists we surveyed also said they were writing or filling fewer opioid prescriptions, or had stopped them altogether.  

“My doctor cut me off hydrocodone cold turkey last fall leading to an overnight in the hospital emergency room,” a patient with chronic back pain and anxiety told PNN. “For years I have been stable on a mix of hydrocodone and Valium. Last October my doctor said he would only fill one prescription and asked me to make a choice so I stayed with the Valium.”

“With the VA allowing me only 2 hydrocodone per day now, I get very little exercise and stay in bed a lot,” a 70-year old veteran wrote. “My quality of life has gone down considerably. Before the changes, I stayed quite active taking 4 hydrocodone a day.”

“I had an interventional pain management doctor scream at me that the guidelines were mandatory and he refused to write for any type of opioids even though I've been on the same level of hydrocodone for several years,” another patient said.

“I took hydrocodone pain medicine for 25 years as the doctor proscribed. Never called in for more, now I'm having to go a pain doctor and get steroid shots every 3 months,” wrote a patient with lives with chronic back pain.

Overall spending on prescription drugs in the U.S. reached $323 billion in 2016, a 4.8% increase that is less than half the rate of the previous two years. The QuintilesIMS report blames the slowdown in growth on increased competition among drug makers and efforts to limit price increases.

“New medicines introduced in the past two years continue to drive at least half of the total growth as clusters of innovative treatments for cancer, autoimmune diseases, HIV, multiple sclerosis, and diabetes become accessible to patients,” said Murray Aitken, Senior Vice President and Executive Director, QuintilesIMS Institute.

McCain Calls for New Study of Veteran Suicides

By Pat Anson, Editor

Arizona Senator John McCain has reintroduced legislation that calls for a comprehensive review of veteran suicides by the Department of Veterans Affairs (VA), including the role of opioids and other prescription drugs in their deaths.

Veterans suffer from high rates of chronic pain, depression and post-traumatic stress disorder (PTSD). According to a recent VA study, an average of 20 veterans die each day from suicide, a rate that is 21 percent higher than the civilian population.

“The tragedy of 20 veterans a day dying from suicide is a national scandal,” said McCain. “Combatting this epidemic will require the best research and understanding about the key causes of veteran suicide, including whether overmedication of drugs, such as opioid painkillers, is a contributing factor in suicide-related deaths.”

If passed, the Veterans Overmedication Prevention Act would authorize an independent study by the National Academies of Sciences of veterans who died of suicide, violent death or accidental death over the last five years – including what drugs they were taking at the time of their death.

The bill specifically calls for a listing of “any medications that carried a black box warning, were prescribed for off-label use, were psychotropic, or carried warnings that include suicidal ideation.”

SEN. JOHN MCCAIN

Dozens of medications prescribed to treat chronic pain, depression or PTSD are psychotropic – meaning they affect a patient’s mental state. They include tranquilizers, sedatives, antidepressants and anticonvulsants such as Lyrica (pregabalin), Cymbalta (duloxetine), Neurontin (gabapentin), Xanax (alprazolam), and Valium (diazepam). Many of the drugs also have warning labels that they “may cause suicidal thoughts or actions.”

McCain’s bill may bring new attention to something that is rarely discussed in the national debate over opioids and the overdose epidemic: many of the drugs prescribed "off label” as alternatives to opioids raise the risk of suicide and have other side effects.

“I almost committed suicide myself after being prescribed Lyrica and Cymbalta. I went from 190 pounds to 300 pounds, and had suicidal thoughts almost from the outset,” Alessio Ventura wrote in a recent guest column for PNN. “After the Lyrica and Cymbalta were stopped, I stayed on OxyContin and had bi-weekly testosterone shots. I lost all of the weight and the suicidal thoughts went away. It was a miracle.”

Vietnam veteran Ron Pence was pressured by VA doctors to take Cymbalta for his chronic arthritis.

“The VA is really pushing these drugs that I would not give to a dog. They are a lobotomy in a pill. I WILL DIE BEFORE TAKING THEM. They take away your ability to think, speak and make decisions; and come with side effects such as permanent blindness, kidney stones and suicide, even in non-depressed people with no mental problems,” Pence wrote in a guest column.

“Even trying to get off this drug under a doctor's care can end in death for some people. Besides that, it’s nothing more than a sugar pill for the pain.”

As PNN has reported, the VA recently adopted new clinical guidelines that strongly recommend against the prescribing of opioids for chronic pain. The guidelines recommend exercise and psychological therapies such as cognitive behavioral therapy, along with non-opioid drugs such as Neurontin. No mention is made that Neurontin and other non-opioid drugs raise the risk of suicide, only that they “carry risk of harm.”

McCain’s bill would require the National Academies of Science to study the medications or illegal substances in the system of each veteran who died; whether multiple medications were prescribed by VA physicians or non-VA physicians; and the percentage of veterans who are receiving psychological therapy and its effectiveness versus other treatments.

Few Drugs Effective in Treating Neuropathy Pain

By Pat Anson, Editor

Cymbalta and some other anti-depressants are moderately effective at relieving diabetic nerve pain, according to a new report by the Agency for Healthcare Research and Quality (AHRQ).

But researchers found little or no evidence that opioids, Lyrica, Neurontin and other widely prescribed medications are helpful in treating neuropathy pain.

Nearly 26 million Americans have diabetes and about half have some form of neuropathy, according to the American Diabetes Association. 

Diabetic peripheral neuropathy causes nerves to send out abnormal signals. Patients can feel stinging or burning pain, as well as loss of feeling, in their toes, feet, legs, hands and arms.

"Providing pain relief for neuropathy is crucial to managing this complicated disease," said lead author Julie Waldfogel, PharmD, of The Johns Hopkins Hospital in Baltimore.

"Unfortunately, more research is still needed, as the current treatments have substantial risk of side effects, and few studies have been done on the long-term effects of these drugs."

In a systematic review of over 100 clinical studies published in the journal Neurology, AHRQ researchers found moderate evidence that the SNRI antidepressants duloxetine (Cymbalta) and venlaxine (Effexor) were effective in reducing neuropathic pain. Nausea, dizziness and somnolence were common side effects of the drugs.

The evidence was weaker for anti-seizure medication such as pregabalin (Lyrica) and oxcarbazepine (Trileptal). Common side effects from those drugs are weight gain, dizziness, headache and nausea.

While pregabalin works in the same way as gabapentin (Neurontin) -- both are often used to treat nerve pain -- the reviewers found gabapentin was not more effective than placebo. The seizure drug valproate and capsaicin cream were also found to be ineffective.

Oxycodone was not effective in treating neuropathy pain, and the evidence was weak for two other opioids, tramadol and tapentadol.

The U.S. Food and Drug Administration has approved only three medications -- duloxetine, pregabalin and tapentadol -- for diabetic nerve pain. However, many others drugs are prescribed “off label” for the disease.

"We hope our findings are helpful to doctors and people with diabetes who are searching for the most effective way to control pain from neuropathy," said Waldfogel. "Unfortunately, there was not enough evidence available to determine if these treatments had an impact on quality of life.”

Researchers noted that all of the studies were short-term, many for less than three months, and even the most effective drugs had relatively high rates of side effects. They say longer-term studies are needed so that adverse effects and the continued effectiveness of the drugs can be assessed.

Lyrica, Cymbalta and Savella: Do They Work?

By Lana Barhum, Columnist

If you have fibromyalgia, chances are your doctor has prescribed one or more of the three drugs approved for fibromyalgia by the U.S. Food and Drug Administration (FDA).   It is also likely you have been disappointed when they didn’t work and by the side effects they caused.

I have tried Lyrica (pregabalin), Cymbalta (duloxetine) and Savella (milnacipran). My experience is they don’t work well and clinical research doesn’t offer up enough credible evidence that they do.

Patient feedback on these medications is actually more telling than recent studies.  Just check any fibromyalgia online forum and you will find your unpleasant experiences with these medications aren’t unique and shared by many.

Lyrica

Lyrica was developed by Pfizer as a treatment for epilepsy, but it is now widely prescribed for many different types of pain. Lyrica was approved by the FDA in 2007 as the first drug specifically for the treatment of fibromyalgia. Pfizer notes on its website that Lyrica “significantly relieves fibromyalgia pain and improves physical function” in fibromyalgia patients.  But does it really?

An initial study from 2005, with results published in Arthritis & Rheumatology, found Lyrica to be effective at relieving pain in only 29% of the 529 fibromyalgia patients in the study group. 

A major shortcoming of the study was that weight gain affected 10% of the study participants.

What was also interesting about the Arthritis & Rheumatology study is that a large number of participants dropped out due to Lyrica's side effects, which included edema, dry mouth, weight gain, infection, increased appetite and constipation.

A 2014 study of out of the University of Calgary, with results published in the journal Therapeutic Advances in Drug Safety,  also found that Lyrica causes edema and weight gain in some patients. 

Those side effects, especially the weight gain, aren’t worth it for a drug that doesn’t seem to work well for most people. You would get more benefit from dietary changes for fibromyalgia than with Lyrica - at least that was my experience. 

All I got from taking Lyrica was a 40 pound weight gain that took me two years to take off. I made the mistake of staying on it for too long, believing that it would one day work for me.

Cymbalta

Cymbalta was originally developed and marketed by Eli Lilly as a treatment for depression. You may even remember some of the commercials for it. In 2008, Cymbalta become the second drug approved by the FDA to treat fibromyalgia.

While Cymbalta doesn’t have stellar ratings amongst fibromyalgia patients, it does outperform Lyrica in my opinion. Initial trials, with results published in The Primary Care Companion to The Journal of Clinical Psychiatry, show that over a third (36%) of study participants reported at least a 50% reduction in pain, based on a dosage of 60 mg once or twice per day.

A report published in the journal Expert Review of Clinical Immunology found that many participants dropped out of Phase I, II, and III trials of Cymbalta due to side effects, including nausea, headache, and sleep issues. 

Cymbalta has given me some pain relief over the years, but I have also made changes to my diet and lifestyle which may have helped as well.  If Cymbalta has helped me with anything, it is managing the depressed feelings fibromyalgia often leaves in its wake.

Savella

My Savella experience was far worse than my experiences with Lyrica and Cymbalta.  I could only stay on it for two weeks because the side effects were more than I could handle. Dizziness, vertigo, nausea, fatigue, and severe headache were a few of the side effects that stood out.  And I didn’t get any fibromyalgia pain or symptom relief.

Savella was developed by Forest Laboratories specifically for fibromyalgia and was approved by the FDA in 2009.

Like Lyrica and Cymbalta, studies confirm Savella’s poor performance. One double-blind study, reported in the journal Pharmacy & Therapeutics, found that only about one in four fibromyalgia patients (26%) were getting pain relief. 

The rate of discontinuation due to Savella’s side effects and treatment failure was also high -- nearly 43 percent.

In 2010, the consumer advocacy group Public Citizen petitioned the FDA to remove Savella from the market because it increased blood pressure in patients who didn’t have high blood pressure to start with. The group also argued Savella posed an increased risk for suicidal thoughts.

The FDA responded last year and denied Public Citizen’s petition, but said it would continue to monitor the safety of Savella.

My Thoughts

The only medication that I have seen that offers real improvement is Pfizer’s Neurontin (gabapentin), which is prescribed “off label” because it is not specifically approved to treat fibromyalgia by the FDA. Neurontin has helped my nerve pain and I also take muscle relaxers as needed, as I am frequent sufferer of muscle cramps and spasms. 

Studies have confirmed Neurontin’s effectiveness in treating fibromyalgia pain and improving sleep and fatigue. One double-blind study, with results published in Arthritis & Rheumatism, found that over half (51%) of fibromyalgia patients were finding relief with Neurontin.   

That’s not bad for a medication that was originally developed to manage seizures and whose formula has been the same since 1993. While it has helped me, I certainly understand Neurontin hasn’t helped everyone. There are even reports of Neurontin being abused by addicts. 

I am not sure why the makers of Lyrica, Cymbalta and Savella continue to market medications that don’t offer most people real results.  Yet, these medications remain available and doctors are still prescribing them to treat fibromyalgia. 

Let's just hope there are new fibromyalgia drugs on the horizon that actually work and give us real and reliable symptom and pain relief.

What has been your experience with Lyrica, Cymbalta and Savella?

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother. Having lived with rheumatoid arthritis and fibromyalgia since 2008, Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit her website.

The information in 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.

Lyrica and Cymbalta Advised for Diabetic Neuropathy

By Pat Anson, Editor

New guidelines by the American Diabetes Association for the treatment of diabetic neuropathy strongly discourage the use of opioids to treat nerve pain, while recommending pregabalin (Lyrica) and duloxetine (Cymbalta).

Nearly 26 million people in the United States have diabetes and over half have some form of neuropathy, which often causes a painful stinging or burning sensation in the hands or feet.  Nerve pain is often the first symptom that prompts people to seek medical care before getting a diabetes diagnosis.

Researchers at the University of Michigan led a group of internationally recognized endocrinologists and neurologists, and teamed up with the American Diabetes Association (ADA) to craft a new position statement on the prevention, treatment and management of neuropathy. The ADA last released a statement on diabetic neuropathy in 2005.

"Our goal was to update the document so that it not only had the most up-to-date evidence, but also was easy to understand and relevant for primary care physicians," said lead author Rodica Pop-Busui, MD, a professor of internal medicine at Michigan Medicine Division of Metabolism, Endocrinology and Diabetes.

"Treatment of neuropathy pain is specifically relevant because, unfortunately, there has been much overprescribing of narcotics for neuropathic pain."

Although opioids like oxycodone and tramadol are effective in relieving nerve pain, they are not recommended by the ADA as a first, second or even a third-line treatment.

“Despite the demonstrated effectiveness of opioids in the treatment of neuropathic pain, there is a high risk of addiction, abuse, sedation, and other complications and psychosocial issues even with short-term opioid use. For these reasons, opioids are not recommended in the treatment of painful DSPN (distal symmetric polyneuropathy) before failure of other agents that do not have these associated concerns,” the guideline states.

Instead of opioids, the ADA recommends either pregabalin (Lyrica) or duloxetine (Cymbalta) as an initial treatment for neuropathic pain. Gabapentin (Neurontin) can also be considered.

PNN readers often complain of side effects from all three drugs – such as depression, fatigue, nausea, headache and weight gain -- yet the ADA statement only vaguely warns that their “adverse effects may be more severe in older patients.”

"Lyrica did help with my nerve pain but the side effects were intolerable and the withdrawal was absolute hell," said Laura.  "I gained 20 pounds in a month and was even more of a zombie than when I was on gabapentin. I had no personality, no interest in anything, and had completely lost motivation to do anything."

"I have been on Cymbalta a couple of years. It has helped overall with depression, anxiety and pain. I also can't miss a dose or try to quit cold turkey," wrote Rebecca Williams. "I become very dizzy, nauseated, night sweats, crazy dreams, electrical zaps in my head. I don't know how I would ever get off of it because the withdrawal symptoms are unbearable."

The ADA guidelines recommend that physicians try different therapies to prevent or slow the progression of diabetic neuropathy, most of which focus on controlling high blood sugar (glucose), which can cause irreversible damage to small nerve fibers. Insulin, regular exercise and a low-calorie, low-fat diet can help regulate glucose levels.

To see the ADA’s recommendations, click here.

‘Wakeup Call’ for Neurontin Abuse

By Pat Anson, Editor

A drug that is often prescribed as an alternative to opioid pain medication is increasingly being abused by patients, according to a small study that found one out of five patients taking the drug illicitly.

Gabapentin – which is sold by Pfizer under the brand name Neurontin -- is approved by the Food and Drug Administration to treat epilepsy and neuropathic pain caused by shingles.

It is also prescribed “off-label” for a variety of other conditions, including depression, migraine, fibromyalgia and bipolar disorder.

In a study of urine samples from 323 patients being treated at pain clinics and addiction treatment centers, 70 patients were found to be taking gabapentin without a prescription.

“The high rate of misuse of this medication is surprising and it is also a wakeup call for prescribers. Doctors don’t usually screen for gabapentin abuse when making sure patients are taking medications, such as opioids, as prescribed. These findings reveal that there is a growing risk of abuse and a need for more robust testing,” said Poluru Reddy, PhD, medical director of ARIA Diagnostics in Indianapolis, IN. Reddy presented his study at the annual meeting of the American Association for Clinical Chemistry in Philadelphia.

Researchers found that of those patients taking gabapentin illicitly, over half (56%) were taking it with an opioid, about a quarter (27%) with an opioid and muscle relaxant or anxiety medication, and the rest with other substances. The urine samples came primarily from pain clinics in Indiana, Arizona, and Massachusetts.

“Little information exists regarding the significance of Gabapentin abuse among clinical patients. Until recently, it was considered to have little potential for abuse however this review has shown that a significant amount of patients are taking Gabapentin without physician consent. This could be due to the fact that recent studies have revealed that Gabapentin may potentiate the ‘high’ obtained from other central nervous system acting drugs,” wrote Reddy.

"Patient safety is Pfizer’s utmost priority.  We strongly support and recommend the need for appropriate prescribing and use of all our medicines," a spokesperson for Pfizer said in an email to Pain News Network.

Gabapentin is not scheduled as a controlled substance and when taken alone there is little potential for abuse. But when taken with other drugs, such as opioids, muscle relaxants, and anxiety medications like Valium and Xanax, researchers say gabapentin can have a euphoric effect.

Between 2008 and 2011 the number of emergency room visits for misuse or abuse of gabapentin increased by nearly five times, according to the Drug Abuse Warning Network. Side effects from gabapentin include weight gain, dizziness, ataxia, somnolence, nervousness and fatigue.

Increased Prescribing of Gabapentin

A report by IMS Health found that 57 million prescriptions for gabapentin were written in the U.S. in 2015, a 42% increase since 2011.

Gabapentin is one of several medications being promoted by the Centers for Disease Control and Prevention as a "safer"  alternative to opioids.  The American Pain Society recently recommended that gabapentin be considered for post-operative pain relief.

But the growth in gabapentin prescribing is drawing scrutiny in the UK, where the Advisory Council on the Misuse of Drugs (ACMD) recommended earlier this year that gabapentin and pregabalin (Lyrica) be reclassified as Class C controlled substances, which would make them harder to obtain.

“Both pregabalin and gabapentin are increasingly being reported as possessing a potential for misuse. When used in combination with other depressants, they can cause drowsiness, sedation, respiratory failure and death,” said Professor Les Iverson, ACMD chairman, in a letter to Home Office ministers.

“Pregabalin causes a ‘high’ or elevated mood in users; the side effects may include chest pain, wheezing, vision changes and less commonly, hallucinations. Gabapentin can produce feelings of relaxation, calmness and euphoria. Some users have reported that the ‘high’ from snorted gabapentin can be similar to taking a stimulant.”

Gabapentin is "one of the most abused and diverted drugs” in the U.S. prison system, according to Jeffrey Keller, MD,  the chief medical officer of Centurian, a private company that provides prison healthcare services.

“Inmates show up at my jails all the time with gabapentin on their current medication list,” Keller wrote in Corrections.com. “It produces euphoria, a marijuana-like high, sedation, and, at high enough doses, dissociative/psychedelic effects. It works so well that it is used in the drug community to mellow out methamphetamine tweaking and to cut heroin. Since drug abusers know about these illicit uses of gabapentin on the streets, once they get to jail they often view gabapentin as an obtainable ‘jail substitute’ for their preferred drugs.

“Unfortunately, the abuse potential of gabapentin is not recognized much outside of jails and prisons. Community prescribers are generally unaware that gabapentin can be misused and (in my experience) are often incredulous and even disbelieving when told about ‘the dark side’ of gabapentin.”

Gabapentin (Neurontin) has a checkered history. Originally developed as a nerve drug, Pfizer agreed to pay $430 million in fines to resolve criminal and civil charges for illegally marketing Neurontin to treat conditions it was not approved for. According to some estimates, over 90% of Neurontin sales are for off-label uses.

In 1999, a Pfizer executive was so mystified by Neurontin’s popularity he called it the “snake oil of the twentieth century.”