What You Need to Know About Chronic Pain

By Sarah Elizabeth Hirschle, Guest Columnist

This is a side of my life not many know about, except close friends and family.

This is me when traveling anywhere over an hour away. I can only sit in the car for up to an hour. I was traveling to my doctor's appointment several hours away. 

I share for awareness, not pity.

In the past three weeks, I have been able to leave the house twice a week at most. Some of those days were just short car rides to get some fresh air and sun. 

This is the sad reality of so many chronic pain patients. Much more awareness is needed, especially in the medical community. 

If you have a loved one that is suffering from pain, please listen. Talk to them, let them know you care. Even if you don't know what to do to help or hate seeing them that way. 

A few things to know about chronic illness and pain:

SARAH ELIZABETH HIRSCHLE

• The pain causes depression and depression causes pain.

• Pain is very isolating, making patients feel unlovable and alone, when in fact we need love and companionship the most at these times.

• True chronic pain patients who are on narcotics for pain do not get high from their meds.

When your body is under stress and in insurmountable amounts of pain, all you get from opioid medication is relief. There is a big difference between dependence and addiction.

We do what whatever is necessary to have some quality of life.

Please reach out if you know someone is suffering. You may save their life without knowing it.

Sarah Elizabeth Hirschle lives in Pennsylvania. Sarah contracted Lyme disease as an infant, which caused permanent organ damage. At age 20, her spinal cord was damaged during a botched epidural and she developed arachnoiditis.  Sarah also lives with Chronic Regional Pain Syndrome in her legs and feet.

Sarah helps run a Facebook support group called Arachnoiditis Everyday and moderates the Facebook page of the Arachnoiditis Society.

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

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

Pain Poem: A Misery Too Great to Bear

"A Misery Too Great to Bear"

By Angelika Byczkowski

People in pain are dying,
a reluctant calculation,  
the only option left to escape
a misery too great to bear.

While we struggle with our pain,  
our government has decided   
to snatch relief from opioids  
away from us for our own good.  

They say one pill begins the end,  
addiction guaranteed.
We say we need a powerful shield
only opioids can provide.  

By policy now unarmed, defenseless,
we are stalked by pain through every moment.  
It hunts us down relentlessly,  
sinks fangs in deep and feasts.

It rips the flesh and breaks the bones,   
cracks the skull and snaps the spine,  
with license to do just as it pleases,  
impunity guaranteed by decree.  

We are sent out naked now  
to battle this rampaging pain  
with methods long disproven, yet  
"believe and it will be" they say.

Denied our armor, medication  
callously denied by guidelines,   
we teeter at the ragged gash  
where soul was ripped from body.  

How much pain and for how long  
can we be asked to bear,  
while experts coin their catchy phrases,  
call our pain "catastrophizing".

A catastrophe indeed is pain:
It traps us in the wreckage,  
wandering the sad remains    
of tortured flesh that cannot heal.

What we know is pain, we feel  
only pain, exploding pain,  
pain so bad it breaks our will
to live like this forever.  

Pain dominates, annihilates,
ruthless in its roaring rage, while  
helpless at the feet of the beast,
we lie sacrificed for overdoses not ours.

People in pain are dying,
a reluctant calculation,  
the only option left to escape
a misery too great to bear.

Angelika Byczkowski suffers from Ehlers-Danlos Syndrome and fibromyalgia. Until she was disabled by progressive pain and fatigue, Angelika was a high tech IT maven at Apple and Yahoo. She lives in California’s Santa Cruz Mountains with her husband and various four-legged kids.

When pain isn't keeping her flat on her back, she spends her limited energy researching and blogging about chronic pain, EDS, and fibromyalgia at EDS Info.

Pain News Network invites other readers to share their stories (and poems). Send them to:  editor@PainNewsNetwork.org. 

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

Better Analysis Needed on Non-Medical Use of Opioids

By Willem Scholten, PharmD MPA, Guest Columnist

A few months ago, the medical journal World Psychiatry published an article that focused on the global non-medical use of prescription drugs, particularly psychoactive substances such as opioids.

Unfortunately, the two authors -- Dr. Silvia Martins and Dr. Lilian Ghandour -- ignored the distinction between prescription and prescribed opioids, adding unnecessary confusion to the already complex debate about access to pain treatment. Further, Dr. Martins said in the Washington Post that the non-medical use of psychoactive substances could turn into a pandemic if we are not careful.

Both authors are affiliated with Columbia University’s Mailman Institute of Public Health, which claims to work in the interest of underserved people in developing countries. Access to effective pain treatment in developing countries is already now more difficult than in the U.S.

Elsewhere, I have demonstrated that access to prescribed opioids for adequate pain treatment is a problem for 5.5 billion people living in countries where opioid analgesics are not available or inaccessible for patients in need.

In most countries, the per capita consumption of legitimately prescribed opioid analgesics (as officially reported to the International Narcotics Control Board) remains much lower than in the U.S. and Canada, in extreme cases even up to 50,000 times lower.

Distinction Between “Prescribed” and “Prescription” is Key

There is a vast difference between prescription and prescribed opioids. Prescription opioids are intended to be prescribed as medicines. Prescribed medicines are actually prescribed by a physician and dispensed by a pharmacy.

About 75% of fatal overdoses from prescription opioids in the U.S. occur in people who have not been prescribed opioids during the three months preceding their deaths. Thus, the majority must have obtained these prescription opioids on the black or gray market.

Without referencing the data, Drs. Martins and Ghandour claim that prescription opioids are causing serious problems in other parts of the world. However, data from the European Monitoring Centre for Drug and Drug Addiction and the European Drug Report indicate that diversion of prescription opioids is not a serious problem in Europe. In other regions of the world, per capita prescription of opioids is very low.

Drs. Martins and Ghandour claim a high prevalence of non-medical use of prescription opioids in Saudi Arabia. However, those medicines are hardly ever prescribed in that country and medical consumption rates are only about 2.5 % of the U.S. volume. Therefore, Saudi Arabia’s non-medical use of prescription opioids can hardly originate from prescribed opioids.

Unfortunately, World Psychiatry refused to publish a letter I wrote with other experts which addressed the misunderstandings stemming from Drs. Martins and Ghandour’s article.

PROP and the Anti-Opioid Lobby

The anti-opioid lobby in the U.S. does not shy away from using arguments not based on facts, just like Drs. Martins and Ghandour in their article. For example, Physicians for Responsible Opioid Prescribing (PROP) perpetuates the mistaken conflation of prescription and prescribed opioids, advocating in the U.S. against the legitimate medical prescribing of opioid analgesics. PROP tries to justify its position using false statistics, as I demonstrated in a recent publication.

Moreover, PROP leadership participated in drafting the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. PROP Executive Director Dr. Andrew Kolodny disclosed his involvement, but PROP President Dr. Jane Ballantyne and PROP Vice President Dr. Gary Franklin did not list the group as a relevant conflict of interest on their disclosure forms.

The Steve Rummler Hope Foundation is the “fiscal sponsor” of PROP. Its vision is “a world where individuals with chronic pain receive integrated care focused on wellness rather than drugs.” For patients with moderate or severe pain, this can hardly be an effective and humane treatment. PROP’s close ties with the Steve Rummler Foundation are revealed by Dr. Kolodny’s and Dr. Ballantyne’s membership on its medical advisory committee.

Policies Should Balance All Public Health Interests

Indeed, it is correct to attend to the non-medical use of psychoactive substances. However, the situation outside the U.S. is really different. In many countries, patients have no access to adequate pain management. Measures to address non-medical use of opioids should not hamper access to effective pain management.

Policymakers in countries with a low per capita medical opioid consumption and low prescription rates should first analyse how prescription opioids that have not been prescribed enter circulation. The relationship between the non-medical use of prescription opioids and illicitly produced substances such as heroin should also be taken into consideration. Then, appropriate interventions to halt the diversion should be developed.

In parallel, policymakers should develop policies aimed at ensuring adequate provision of pain treatment as recommended by the World Health Organization. Optimal public health outcomes can only be attained when policies to minimize non-medical use are balanced with policies to maximize access to adequate pain management. Crafting such policies entails correctly distinguishing between prescribed and prescription opioids.

Willem Scholten, PharmD MPA, is an independent consultant for medicines and controlled substances at Willem Scholten Consultancy in the Netherlands. This has included work for DrugScience, Grünenthal, Jazz Pharmaceuticals, Mundipharma, Pinney Associates and the World Health Organization. Dr. Scholten is also a board member of International Doctors for Healthier Drug Policies.

He wishes to acknowledge Dr. Katherine Pettus for her contribution to this article.

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

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

The Media’s Addiction to Opioids

By Roger Chriss, Columnist

A recent and very brief CDC report described 59 pneumonia deaths in Minnesota between 2006 and 2015 that involved opioids. The gist of the study was that “opioid users are at increased risk for pneumonia” and therefore the deaths should have been reported as opioid related overdoses, even though the autopsy reports list pneumonia as the cause of death.

Vox said the study suggests “the opioid epidemic may be even deadlier than we think,” while the Daily Mail warned it was “just the tip of the iceberg” and that “we may have grossly underestimated the scale of the opioid epidemic.”

JAMA Surgery also recently published a study, which found that about 6 percent of surgery patients continued to use opioids more than three months after their surgery.

U.S. News cited the study to proclaim that “Many Opioid Addictions Surface After Surgery,” while MedicalXpress said it was proof that someone could go “from opioid-free to long-term user, in one operation.”

Both the CDC report and the JAMA Surgery study were grossly misrepresented. Fear sells, and the opioid crisis has become a favorite source of fear-mongering in the media.

The CDC report is a one page, four-paragraph document released by the agency’s Epidemic intelligence Service (EIS). It never mentions the words “addiction” or “epidemic,” yet it leaps to one very big conclusion.

“The total burden of opioid-associated deaths was underestimated in Minnesota,” the report says. “The contributions of opioid toxicity, infectious disease, or their interactions to death are challenging to disentangle; understanding these interactions might inform future opioid-related mortality prevention efforts.”

The JAMA Surgery article is a retrospective study which found an association between post-operative use of opioid medications for pain management and patient history of smoking and alcohol use. The study looked at opioid abuse only as an exclusion criteria for the patient population; it was not a study about addiction in any form. The JAMA article concludes by saying that “new persistent opioid use represents a common but previously underappreciated surgical complication that warrants increased awareness.”

In other words, we have intriguing results that should be investigated further, with the ultimate goal of improving public health and welfare. Unfortunately, all that is lost in the alarmist media coverage that mischaracterizes the findings, over-interprets the data, and extrapolates consequences to reach what at best are highly premature conclusions.

In its coverage of the CDC report, CNN quoted EIS officer Victoria Hall, DVM, as saying that the Minnesota data represents “an iceberg of an epidemic.” 

Keep in mind that Hall is not an epidemiologist, an infectious disease specialist or an expert on icebergs. She is a veterinarian by training and a recent graduate of Mississippi State University's College of Veterinary Medicine. Hall has been working for the CDC less than a year, according to her LinkedIn profile.

In a CDC media briefing, Hall refers to only one specific case in Minnesota: a middle-aged man dying of pneumonia, who was on opioid therapy for chronic back pain. This case is not mentioned in the CDC EIS report. His death may be an important hint of a new facet of the opioid crisis, or it may be an anomalous outcome. More work is needed to figure out what is really going on. For now, it bears remembering that the plural of anecdote is not data.

VICTORIA HALL, DVM

Similarly, U.S. News reported on the JAMA Surgery article by stating that, “Some surgery patients prescribed opioids for post-operative pain relief may face a high risk for developing a long-term opioid addiction, new research warns.” This report also appeared on Philly.com  and on WebMD , spreading the misinformation about addiction risks, which were never even mentioned in the article.

In other words, there was a huge and speculative leap from the data in the CDC report about 59 opioid-related pneumonia deaths over a decade-long period all the way to a stealth epidemic sweeping the nation. And an equally large jump from an association between the duration of post-surgical opioid use and patient social history to a new source of opioid addiction.

The sensible response is to call for further research. For the CDC, this means collecting data from all 50 states about otherwise unexplained deaths and seeing if opioids are involved in any of them, then following up with analysis on possible under-reporting. For the world of surgery, this means performing prospective trials to see if the reported association holds up, and then investigating if such use increases the odds of a patient developing opioid use disorder.

For now, we just don’t have the data to figure out what is going on. And as Sherlock Holmes says: “It is a capital mistake to theorize before one has data.”

Roger Chriss suffers from Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

The Difference Between Addiction and Dependence

By Michael Thompson, Guest Columnist

When a person consumes alcohol or takes a mood altering medication, several things start to happen. First, they begin to develop a tolerance for it, so that over time it takes more of the drug to get the same effect. That can lead to abuse and addiction.

A person may also develop a dependence on a drug.  That means they have a clinical need for a medication.  

Many pain sufferers have found they need more opioid medication to provide relief from their pain, but that doesn’t mean they abuse or misuse it. It also doesn’t make them addicts.

I am dependent on my blood pressure medication to keep my blood pressure in check, but I’m not addicted it. Diabetics are dependent on their medication, but they are not addicted. 

Last year the CDC came out with opioid prescribing guidelines for general practitioners. But restricting the legal prescribing of these drugs will have no effect on the fact that most addicts don’t get their medication from Walgreens or Wal-Mart.  They get their drugs from Bobby the Rat behind Walgreens, or behind the pool hall from Billy the Snitch or Joe the Jerk.  What Bobby, Billy and Joe are selling is heroin, counterfeit painkillers and other illegal drugs.

What effect do these restrictive guidelines have on the illegal use of opioids?  None whatsoever.  The prescribing of opioid painkillers has been on the decline for years.  Most people who overdose are killing themselves with illegal drugs, not drugs obtained from their family doctor. 

Sure, everyone has heard of doctor shopping junkies who will go to an unscrupulous physician, who for $20 in cash will write an opioid prescription without even an examination. But the number of addicts pales in comparison to the number of legitimate chronic pain suffers who have been on these quality-of-life saving drugs for years without ever abusing their medications. Most have no idea where to find Bobby, Billy or Joe, or how to go about buying illegal drugs on the street.

Millions of older adults suffer from osteoarthritis and other neurologically painful conditions for which there is no cure, but there is treatment.  Many are on high doses of pain medication and have been taking these drugs for years, without ending up in the gutter shooting heroin or with a tag on the toe, lying on a tray in in the county medical examiner’s office.  They are not the ones causing headlines. 

Many doctors wrongly believe the CDC guidelines are rules that apply to all who prescribe opioid medication.  They fear that the DEA will come barging in if they go over a minimal amount, prosecute them and take away their license.  Their fear has left many chronic pain patients hanging out to dry, including some who will die because their pain is not being appropriately treated. 

If you have ever suffered from chronic, intense pain you are aware that it is all consuming.  It literally takes over your life.  Many, like me, who once led active lives on high doses of opioids, are now housebound, unable to shop, cook, clean or in many cases even just walk from the bedroom to the kitchen. 

It is a horrible existence, sitting in a chair all day, just trying to make it from morning to evening, and then unable to sleep because the pain is so intense.  Many of these once functional chronic pain sufferers have had their medication cut in half or more. 

As a personal example, I have two torn rotator cuffs that won’t heal.  I have had two surgeries that failed to correct the problem.  My surgeon says he won’t do any more surgeries because the rotator cuffs just continue to tear.  But that’s not all.  I have no cartilage left in my knees, a detached bicep tendon in my left elbow, and peripheral neuropathy in my feet and hands that causes them to burn and ache.  It’s been years since I was able to wear shoes. 

Before the CDC guidelines came out, I was on 6 pills of opioid medication a day.  I had been on this dose for five years and never once abused my medication or took more than was prescribed.  I was able to play golf and worked out three times a week, which helped me to keep my weight off.  When my pain specialist cut my dose in half, I literally crashed and burned.  Since then I have been practically home bound.  My story is similar to that of many other chronic pain sufferers.

So what do we do?  Practically every chronic pain patient has been running from one doctor to another, trying to find someone who will maintain them on the medication that helped them to live a somewhat normal life.  Imagine going to a new specialist, only to find the waiting room filled with dozens of other “new patients” trying to find someone, anyone, who wasn’t terrified of the DEA.

Is the CDC aware that their guidelines for primary care doctors have turned into rules for everyone?  Surely someone has told them about this.  Surely they know.

What’s to become of us?  Will we see a spike in the suicide rate of older adults who can no longer stand the daily struggle?  Will anyone care?

There are a lot of organizations that have tried to explain that the guidelines are not hard and fast rules and that they apply only to general practitioners. But fear is a stronger motivator than common sense. 

It cannot be that drug addicts are more important than patients. Don’t suffer in silence. Call, write a letter, or email your senators and congressman.

Don’t know who represents you in Congress? You can look them up by clicking here.

Michael Thompson is a retired clinical social worker and a licensed chemical dependency counselor. He lives in Texas.

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

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

Will Pain Patients Participate in Drug Take Back Day?

By Pat Anson, Editor

Tomorrow is National Prescription Drug Take Back Day, an annual effort by the U.S. Drug Enforcement Administration to give people an opportunity to safely dispose of their unneeded and expired medications.

Last year the DEA and its local law enforcement partners collected nearly 900,000 pounds of unwanted medication – about 447 tons – at almost 5,400 collection sites in all 50 states.

“These results show that more Americans than ever are taking the important step of cleaning out their medicine cabinets and making homes safe from potential prescription drug abuse or theft,” said DEA Acting Administrator Chuck Rosenberg in a news release.

One of the main goals of the DEA is to get patients to dispose of unneeded opioid medication, to prevent the drugs from being stolen, shared or sold.

But with opioid medciation becoming harder to obtain due to federal and state guidelines – and the DEA itself reducing the supply of hydrocodone, oxycodone, and other painkillers by 25 percent or more --   are chronic pain patients going to participate in Drug Take Back Day?

A recent survey of over 3,100 patients by Pain News Network and the International Pain Foundation suggests that many will not. And that government efforts to limit the supply of opioids have turned many responsible patients into hoarders.

Nearly one in four patients – 22 percent – say they are hoarding opioid medications because they’re not sure if they’ll be able to get them in the future.

Nearly half say they are being prescribed a lower dose since the CDC released its controversial opioid guidelines, and almost one in four say they are no longer prescribed any opioids.

“The CDC guidelines have led to a lot of confusion and fear for patients and their doctors. If anything, I ask for more pain medication now because I don't know how much longer I'll be able to obtain it,” one patient wrote.

“I never abused my opiates and in fact have hoarded 30 precious pills,” said another patient.

“I am 65 years old, well educated, and very disabled by (fibromyalgia). I endure the pain, for as long as possible, (and only) then take the meds due to having to hoard the medication,” wrote another.

“It's a no win situation," said a patient. "To be able to get proper relief from a new injury or if surgery comes up, one must hoard enough to treat the additional pain or suffer through it.”

Although the supply of opioid medication has been in decline for years, the news media often makes it sound like painkillers are still being given out like candy, often relying on outdated or inaccurate information that doesn't reflect the current environment.

“The amount of prescription opioids consumed has quadrupled since 1999, and deaths are even higher. Since eight out of ten new heroin users began by abusing prescription painkillers, and most get their pills from family and friends, controlling access to the pills becomes increasingly important,” Judy Stone, MD, wrote in a Forbes article promoting Drug Take Back Day.

Yes, Dr. Stone, it is true that opioid overdoses are soaring, but in recent years that is primarily due to heroin and illicit fentanyl, not prescription opioids. Even the CDC admits that painkillers are no longer driving the opioid epidemic.

The DEA also tells us that less than one percent of legally prescribed painkillers are diverted, which means that 99% of pain patients are responsible about their use and storage of pain medication. Only a small percentage of patients become addicted to opioids and even fewer go on to use heroin.

All of which isn’t to say that Drug Take Back Day is a bad idea. But let’s not use it as another opportunity to stigmatize chronically ill patients who happen to need pain medication.

To find a drug collection site near you, click here.

Stem Cell Vaccine Could Reverse Arthritis

By Pat Anson, Editor

A team of researchers has successfully used gene-editing technology to “rewire” mouse stem cells to fight inflammation – a finding that could pave the way for a new class of biologic drug that replaces cartilage and protect joints from damage caused by arthritis.

The stem cells, known as “smart” cells (stem cells modified for autonomous regenerative therapy), were developed at Washington University School of Medicine and Shriners Hospitals for Children in St. Louis, in collaboration with investigators at Duke University and Cytex Therapeutics in North Carolina.

The research findings are published in the journal Stem Cell Reports.

"Our goal is to package the rewired stem cells as a vaccine for arthritis, which would deliver an anti-inflammatory drug to an arthritic joint but only when it is needed," said senior author Farshid Guilak, PhD, a professor of orthopedic surgery at Washington University School of Medicine.

Guilak and his colleagues grew mouse stem cells in a test tube and then used a gene-editing tool called CRISPR to remove a gene that plays a key role in inflammation. That gene was replaced with a gene that releases a biologic drug that combats inflammation.

Within a few days, the modified stem cells grew into cartilage cells and produced cartilage tissue. Further experiments showed that the engineered cartilage was protected from inflammation.

"We hijacked an inflammatory pathway to create cells that produced a protective drug," explained Jonathan Brunger, PhD, the paper's first author and a postdoctoral fellow in cellular and molecular pharmacology at the University of California, San Francisco.

IMAGE CREDIT: ELLA MARUSHCHENKO

Many current biologic drugs used to treat arthritis – such as Enbrel, Humira and Remicade -- attack an inflammation-promoting molecule called TNF-alpha. But the problem with these drugs is that they interfere with the immune system throughout the body and can make patients susceptible to side effects such as infections.

"We want to use our gene-editing technology as a way to deliver targeted therapy in response to localized inflammation in a joint, as opposed to current drug therapies that can interfere with the inflammatory response through the entire body," said Guilak. “If this strategy proves to be successful, the engineered cells only would block inflammation when inflammatory signals are released, such as during an arthritic flare in that joint."

Researchers have begun testing the engineered stem cells in mouse models of rheumatoid arthritis and other inflammatory diseases. If the work can be replicated in living laboratory animals and then developed into a clinical therapy, the cartilage grown from stem cells would respond to inflammation by releasing a drug that protects them from further damage.

"When these cells see TNF-alpha, they rapidly activate a therapy that reduces inflammation," Guilak explained. "We believe this strategy also may work for other systems that depend on a feedback loop. In diabetes, for example, it's possible we could make stem cells that would sense glucose and turn on insulin in response.

"The ability to build living tissues from 'smart' stem cells that precisely respond to their environment opens up exciting possibilities for investigation in regenerative medicine."

Farshid Guilak and co-author Vincent Willard have a financial interest in Cytex Therapeutics, a startup founded by some of the investigators. They may license the technology and realize financial gain if it is eventually is approved for clinical use.

Guilak and his colleagues at Cytex have also used stem cells to grow new cartilage that could someday be implanted into arthritic hips, delaying or eliminating the need for hip replacement surgery.

Stem cells are found throughout the body and are increasingly being used to develop new treatments to repair damaged tissue and reduce inflammation. The Food and Drug Administration considers most stem cell treatments experimental because their safety and efficacy haven’t been proven through clinical studies.

West Virginia Moves to Stop Opioid Madness

By Kenny Brooks, Guest Columnist

When most people think of West Virginia, they think about mountains, coal mines and miners.  The number of coal miners in West Virginia suffering from black lung, cancer and other chronic illnesses plays a significant role in the state's high rate of disability, estimated at nearly 20 percent of the population. 

Many military veterans in West Virginia also suffer from lifelong pain and disability, as do injured public safety employees, police, firefighters and paramedics. I was severely injured as a paramedic in a work related accident and now live with arachnoiditis, a painful inflammation in my spine that will never go away.

All of this pain and disability has a significant impact on our state. The per capita income of West Virginia is only about $37,000 a year, making it one of the poorest states in the union.  About 23% of West Virginians live below the national poverty line.  We rank 5th highest in suicide and have the highest overdose death rate in the country.

West Virginia was one of the first states to crackdown on pill mills and doctors who overprescribe opioids, but opioid overdoses continue rising, especially from heroin, illicit fentanyl and addicts taking pain medication.

The CDC’s opioid prescribing guidelines only made things worse for real pain patients, causing many to be under treated or abandoned by doctors who took an oath to relieve pain and suffering.

West Virginia lawmakers have seen enough of this suffering. In an unprecedented move, the legislature this month passed Senate Bill 339, with the goal of restoring the integrity of chronic pain management in the state.

The bill was introduced by State Senator Tom Takubo, DO, a pulmonary physician who specializes in treating patients suffering from lung and breathing problems.  Dr. Takubo understands the ethical duty to act, and to help alleviate chronic suffering and pain from incurable chronic conditions.

Senate Bill 339 was approved unanimously by both the House and Senate, and was signed this week into law by the governor.  It recognizes that regulations have caused “patients seeking pain treatment to suffer from a lack of treatment options” and that “prescribers should have the flexibility to effectively treat patients who present with chronic pain.”

The bill also establishes a commission -- called the Coalition for Responsible Chronic Pain Management -- to advise the legislature if a “less cumbersome” manner exists to regulate pain care in the state.

The Coalition will consists of the following members:  The Dean of the School of Public Health at West Virginia University, a physician board certified in pain management, three physicians licensed to practice in West Virginia, a licensed pharmacist, a licensed chiropractor, a licensed physical therapist experienced in the area of chronic pain, and a consumer of healthcare services directly impacted by pain clinic regulations – in other words, a pain patient.

We have about a month before the appointments are made and I am hopeful that I will be appointed as the patient representative. I hope to bring to the Coalition not only my experience as a pain patient, but my experience as a paramedic.  I spent many hours in school years ago learning about medical and legal issues, and believe I have a unique perspective to bring to the table.

My goals are simple: to change the regulations and prescribing guidelines back to individualized patient centered care, not addiction centered algorithms. I am also concerned about doctors being afraid to treat pain patients due to legal reprisals.

I hope to bring a voice of reason to the Coalition, and to help other states look at what we are doing in West Virginia to stop the opioid madness.  

Kenny Brooks is an arachnoiditis survivor and former career firefighter in Montgomery County, Maryland.  He loves his family, his church, his dog, his friends, and he feels very blessed to have a great team of medical doctors and pharmacists who understand quality of life medical care. Kenny became more involved in politics following the sad consequences he witnessed in other arachnoiditis patients due to the CDC guidelines. 

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

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

Limiting Opioids for Acute Pain Will Hurt Everyone

By Patricia Young, Guest Columnist

There is a bill in Congress that, if passed, will have a great negative impact on most people in this country. The legislation by Senators John McCain (R-AZ) and Kristen Gillibrand (D-NY) would limit your doctor’s ability to treat short term acute pain by restricting the supply of opioids to 7 days. This would be a prescription that could not be renewed.

Several states have passed or are considering similar measures to limit the initial supply of opioid medication to a week or less.

I am not sure how these senators came up with the magic number of 7 days for all types of acute pain, but this will cause much undue suffering for innocent people.

As a registered nurse who worked in hospitals and nursing homes for 32 years, I have firsthand knowledge of what happens when acute pain goes untreated. Patients who suffer from acute pain often cannot sleep and become agitated at a time when rest is imperative for healing.

There are many painful and complicated surgeries that make a blanket 7 day restriction on opioid medication absurd. Post-surgical patients often do not stay in the hospital long and the continuation of pain medicine is vital to their healing process. Gastrointestinal surgery often results in an open wound requiring constant dressing changes for weeks.

Most people will eventually be adversely affected if such a bill if passed. Pain is real and comes with most surgeries and many medical conditions.

I recently had arthroscopic hip surgery. I had not been prescribed pain medicine for over a year. At one time I was taking opiates daily, but taking them in that fashion never worked for my chronic pain issues and caused adverse reactions, such as gastroparesis and severe sleep apnea. However, I knew that I would not do well after hip surgery without some pain relief.

I told my surgeon about the adverse reactions and he gave me a prescription for Percocet to use for the first 2 weeks following surgery. I felt good that this doctor had my history and I trusted him to regulate my pain medicine.

I had my surgery done as an outpatient and returned home the same day. My husband took the prescriptions signed by my surgeon to the pharmacy and returned with all of the medications, except for the Percocet. By this time I really needed some pain relief and called the pharmacy to see what happened. I was told that they were not going to fill the prescription for Percocet. They told me my Medicare Advantage Plan (Aetna) was rejecting payment for it.

This was the type of news you just do not need after a painful surgery! I immediately went from feelings of anger to hopelessness. In a couple of weeks I was going to begin 3 months of grueling physical therapy so I could walk again. I also wondered what people did for pain after more complicated surgeries which take longer to recover from. What is happening? Is the government regulating our healthcare so that an insurance company or Medicare can deny coverage for a surgeon’s prescription for post-op pain?

I explained to my pharmacy that my prescription for Percocet was for acute pain following a surgery. The pharmacy decided to look into it. I was fortunate, I was allowed this one prescription filled, but no more. The pharmacy said they would not fill another prescription for a painkiller even if prescribed by my surgeon.

I was only partially relieved now. I knew I had a painful road ahead with 3 months of physical therapy. I looked at the bottle of pain pills and thought this must last throughout my 6 month estimated recovery time. I made the decision to not take a pain pill that day. Yes, I was having a great deal of pain, but I felt I had to take them sparingly. I lost several nights of sleep due to pain because I was afraid to use my pain medicine.

By the 6th day post-op, I had only taken 3 Percocet pills and my pain level was an 8 while lying still. I called my insurance company to verify that I would get no more prescription coverage for pain medicine as the pharmacy had said. I was told different information. My insurance would allow coverage for another prescription, if my surgeon writes one, as long it was not over 180 pills for a month.

My fears about pain during physical therapy were eased and I was relieved that I could start taking my pain pills as prescribed. But why would a pharmacy tell me the wrong information?

This may be why people have to go to several pharmacies to get pain prescriptions filled. It is not because they are addicts or misusing their medication, but because pharmacies are too afraid to fill legitimate prescriptions.

Do cookie cutter rules and policies for pain treatment really promote healthcare for everyone? Or are they simplistic solutions to try and put a band aid on a problem that is completely different -- the disease of addiction?

Patricia Young lives in Florida. In a previous guest column, Patricia shared her experience about being falsely accused of having a “history of addiction.”

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

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

Prescriptions Plummet in Medical Marijuana States

By Pat Anson, Editor

Medical marijuana is giving some serious competition to the prescription drug industry. A new analysis of Medicaid claims found that prescriptions to treat pain, nausea, seizures, psychosis and depression plummeted in the 23 states and District of Columbia where medical marijuana was legal in 2014.

If all 50 states had medical marijuana laws that year, researchers say the potential savings to Medicaid and taxpayers would have been over a billion dollars.

“We found statistically and economically meaningful reductions in prescription drug use associated with the laws. This finding suggested that patients in states with such laws were substituting medical marijuana for prescription drugs,” W. David Bradford and Ashley Bradford, a father-daughter team of researchers at the University of Georgia, reported in the journal Health Affairs.

Previous studies have shown that prescriptions for opioid pain medication have fallen in states where medical marijuana is legal.

The new study was more comprehensive and included nine clinical areas that cannabis could be used to treat: anxiety, depression, glaucoma, nausea, pain, psychosis, seizures, sleep disorders, and spasticity (muscle spasms).

Five of the nine clinical areas had significant drops in prescribing where medical marijuana was legal:

• 17% decline in anti-nausea medication
• 13% decline in antidepressants
• 12% decline in psychosis medication
• 12% decline in anti-seizure drugs
• 11% decline in pain medication

The study found no significant association between medical marijuana laws and drugs used to treat anxiety, glaucoma, sleep disorders or spasticity.

“There is no question that we see patients constantly turning to cannabis, to get off their other medications, mainly to eliminate the side effects they are experiencing.  At this time, this is a huge advantage to us all -- we get a healthier solution to help us with our medical issues and Medicare and Medicaid are seeing a reduction of costs,” said Ellen Lenox Smith, a PNN columnist, medical marijuana user and caretaker in Rhode Island.

“However, until we are able to receive insurance reimbursement like Germany started providing in March, we have to still pay out of pocket. So until we are treated fairly like this in the U.S., we will continue to be paying more for this safer help than if we went to the pharmacy to purchase medication with our co-pays. For me, however, the cost is worth the quality of life I have been able to achieve using cannabis.”

In the current study, researchers cautioned that using fewer prescription drugs is not necessarily a good thing for every marijuana user.

“Our findings do raise important questions about individual behavior. For example, it is plausible that forgoing medications with known safety, efficacy, and dosing profiles in favor of marijuana could be harmful under some circumstances,” said the Bradfords. “In addition, patients who switch from a prescription drug that requires regular physician monitoring to marijuana may interact with their doctor less often, and their adherence to other important treatment regimens could suffer.”

Previous studies have found a significant decline in use of opioid medication by patients who use marijuana and that marijuana users are not at greater risk of alcohol and drug abuse.

Currently medical marijuana is legal in 29 states and the District of Columbia.

Insufficient Evidence: How Opioid Deniers Spin Studies

By Roger Chriss, Columnist

Opioid medications are coming under fire again as being ineffective for chronic pain management.

Charles Pattavina, MD, president of the Maine Medical Association, told the Portland Press Herald that "there is no clinical indication for opioid medication for the treatment of chronic pain."

And Stanford psychiatrist Anna Lembke, MD, said in Vox that “if opioids worked long-term, I would have no problem with patients taking them.”

But sweeping generalizations like these oversimplify a complex situation. Chronic pain is a highly heterogeneous feature of a wide variety of diseases and disorders. And opioids are a broad class of pain medications that come in different doses and are administered by different routes.

Thus, a claim that opioids do not work for chronic pain is too simplistic. Medical researchers investigate carefully posed questions about specific drugs and conditions using the statistical method known as hypothesis testing.

Researchers cannot and do not investigate if “opioids” work for “chronic pain.” Good research is more narrowly focused, such as these clinical studies:

“Tapentadol extended release for the management of chronic neck pain”

“Effectiveness and Safety of Once-Daily Extended-Release Hydrocodone in Individuals Previously Receiving Immediate-Release Oxycodone for Chronic Pain”

“Oxycodone for neuropathic pain in adults”

The results are equally specific. In the first example above, the authors conclude that “our results suggest that tapentadol ER, started at 100 mg/day, is effective and well tolerated in patients with moderate-to-severe chronic neck pain, including opioid-naïve subjects.” Similarly precise statements are found in any such article.

Sometimes researchers will perform a meta-analysis or review in which they assemble a collection of existing research articles and, after a statistical analysis, attempt to draw broader conclusions. Examples include:

“Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects”

“Opioids for chronic pain: new evidence, new strategies, safe prescribing”

“The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop”

The last article above is often cited by opioid deniers, even though it concludes that “evidence is insufficient to determine the effectiveness of long-term opioid therapy for improving chronic pain and function.”

"Evidence is insufficient” means that no determination can be made one way or the other about opioid medications. It does not prove that opioids are ineffective for chronic pain.

This leads to the final defense of opioid deniers: Demand an impossibly high standard of evidence. Specifically, they want the “gold standard” of clinical research: a double-blind, placebo-controlled, randomized trial of a specific drug for a particular condition.

To satisfy this standard, we would have to test every opioid medication against every medical condition causing chronic pain in a variety of different groups of people. This would mean thousands of trials, each performed multiple times, before any meaningful conclusions could be drawn about opioid medications in general. The time and costs involved would be prohibitive in the extreme.

So instead we use observational data and statistical methods to derive reasonable conclusions, as found in the articles above. This approach is widely used in many areas of medical research. In pain research, it has clarified how certain opioid medications can be used to address various chronic pain conditions.

To be clear, opioid therapy can help manage a variety of forms of chronic pain. Not all pain, and not for all patients. And always under the care and guidance of medical professionals.

The goal of opioid therapy is to improve quality of life, and available evidence strongly supports that it does so.

Roger Chriss suffers from Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Warriors Coach in ‘Excruciating' Back Pain

By Pat Anson, Editor

Golden State Warriors coach Steve Kerr is in “excruciating pain” and may miss the rest of his team’s first round playoff series against the Portland Trail Blazers after his chronic back pain "took a turn for the worse." Kerr warned other back pain sufferers "to stay away from surgery."

Kerr was unable to attend Game 3 Saturday night and doesn't know when he’ll return. Sources told the San Jose Mercury News that Kerr was in so much pain he was barely able to walk, which “was scary because it wasn’t a feeling he’s had before.”

The team had only given vague reports that Kerr has an “illness” and is “not feeling well.”

"This past week, for whatever reason, things got worse and my symptoms got worse," Kerr said at a news conference Sunday.  "With things getting worse, I just made the decision that I couldn't coach. As of now, I'm consulting with my doctors. I'm hoping for some improvement. If I get some improvement, I'll get back on the sidelines. 

"I'm not going into details on the symptoms, it's just discomfort and pain. It's not fun. And I can tell you, if you're listening out there,  if you have a back problem, stay away from surgery. I can say that from the bottom of my heart."

In the past, Kerr has complained of headaches, nausea and neck pain.

Kerr missed the first 43 games of the 2015-16 NBA season due to complications from surgery for a ruptured spinal disk. The dura membrane that surrounds Kerr’s spinal cord was punctured during the operation, causing spinal fluid to leak. A second surgery was performed to stop the leak.

“It’s very rare, it does happen occasionally, but it happens when there’s an accidental nick of the dura that surrounds the spinal cord. But I lost spinal fluid, took about a month to figure out what was going on, a lot of headaches, some other symptoms,” Kerr said in October 2015.

Headaches, nausea, and burning, stinging or tingling pain in the back and legs are the classic symptoms of adhesive arachnoiditis, an inflammation that causes scar tissue to build around spinal nerves, causing them to adhere or stick together. The disease is progressive, incurable and difficult to treat.  Many patients developed arachnoiditis after surgeries or epidural steroid injections that permanently damaged their spines.

Neither Kerr or his doctors have said he has arachnoiditis.

There’s a great deal of debate in the medical community over the value of spinal injections, surgeries, spinal cord stimulators and other “interventional” procedures to treat back pain. About 9 million epidural steroid injections are performed annually in the United States, often as a substitute for opioid pain medication.

Patients Could Be Jailed in Florida Drug Crackdown

By Pat Anson, Editor

The Florida legislature is close to passing a bill that would require mandatory minimum sentences for anyone convicted of selling, purchasing or possessing illicit fentanyl.

Critics say the legislation could result in pain patients being sent to jail when they unwittingly buy counterfeit painkillers on the black market that are made with fentanyl.

House Bill 477 was approved unanimously by the Florida House this week.  Similar legislation is under consideration in the Senate. Both bills would put fentanyl, carfentanil, and their chemical cousins in the same drug class as heroin.

Fentanyl is a synthetic opioid 50 to 100 more potent than morphine.  It is available legally by prescription to treat severe pain, but illicitly manufactured fentanyl has become a scourge across the U.S. and Canada, where it is usually mixed with heroin or used to make counterfeit drugs.

As currently written, the House bill requires anyone convicted of having as little as 4 grams of fentanyl to get a mandatory three year prison term; 14 grams would carry a 15-year sentence; and 28 grams would result in 25 years behind bars.

Judges would have zero discretion to alter the sentences. If the drugs result in someone dying, suspects would face a charge of first degree murder.

While the legislation is primarily aimed at cracking down on dealers, critics say patients desperate for pain relief could also face prison if they buy counterfeit oxycodone and other painkillers laced with fentanyl.

"There's a massive problem with counterfeit pills," Greg Newburn, state policy director for Families Against Mandatory Minimums told the Miami New Times.

"You have people who think they’re buying oxy pills who will end up getting labeled as traffickers in fentanyl. A handful of pills could get you three years. If you buy just 44 pills, you could end up with 25 years in prison."

Newburn was surprised the Florida legislature didn’t learn its lesson from previous efforts to require lengthy prison terms for oxycodone and hydrocodone traffickers. Rigid enforcement of the law led to 2,300 people being sent to prison, including some patients who were simply look for pain relief, according to Reason.com.

"When you look back on how the last mandatory-minimum heroin law was applied, you see that it targeted not just just traffickers but a lot of low-level offenders, people who were never supposed to be targeted by the bill in the first place," said Newburn. "We had a heroin mandatory-minimum law for 18 years. Lawmakers promised us it would deter drug use, but now we’re in the midst of the worst heroin crisis we’ve ever seen. And the answer to that is to pass another mandatory minimum?"

Florida was one the first states where counterfeit pills laced with fentanyl began to appear. In early 2016, nine people died in Florida’s Pinellas County after ingesting counterfeit Xanax, an anxiety medication.

“Hundreds of thousands of counterfeit prescriptions pills, some containing deadly amounts of fentanyl, have been introduced into U.S. drug markets, exacerbating the fentanyl and opioid crisis,” the DEA warned in a report last year. “Motivated by enormous profit potential, traffickers are exploiting high consumer demand for prescription medications by producing inexpensive, fraudulent prescription pills containing fentanyl.”

As opioid prescriptions have become harder to obtain, some pain patients are turning to the black market for relief. In a recent survey of over 3,100 patients by PNN and the International Pain Foundation, 11 percent said they had obtained opioids illegally on the black market in the year after the CDC’s opioid guidelines were released.    

Readers Sound Off on Fibromyalgia Drugs

By Lana Barhum, Columnist

In my previous column, “Lyrica, Cymbalta and Savella: Do They Work?” I shared research studies and my own experience with the three medications approved for use in treating fibromyalgia.

Clinical studies on all three drugs don’t seem to offer enough creditable evidence that they are effective in managing fibromyalgia symptoms.  Moreover, they carry very harsh side effects, including weight gain, edema, nausea, headaches, vertigo, sleep issues, and changes in blood pressure.

My experience was similar. Lyrica, Cymbalta and Savella were ineffective for me, and had some tough and life-altering side effects.

It makes me wonder why doctors are still prescribing these medications and why the Food and Drug Administration continues to allow them to stay on the market. 

In 2012, German researchers aimed to assess the benefits and harms of Cymbalta and Savella in treating fibromyalgia.  Ten studies with over 6,000 fibromyalgia patients were reviewed. 

The results were that 22 percent of patients reported substantial relief and 21 percent had to quit treatment due to unpleasant side effects.

In reader comments on our website and Facebook page, many of you had comparable experiences:

“Tried all 3…nothing but weight gain and dizziness. No pain relief. Still haven't found anything that works.”

“I've had multiple spinal surgeries and fusions, and have severe nerve damage. And severe chronic pain. So, I've taken all three of these meds. Without success.”

I will not discount the fact that Lyrica, Cymbalta and Savella work for some people, but they appear to help only about 20 to 30 percent of patients who try them:

“I take one 60mg (of) Cymbalta a day, and it doesn't take away all the pain, but it does make it a bit more bearable.”

“I am using all three. There is relief but in moderation.”

“I have been on Lyrica since 2007 and do have relief of my Fibro pain. I am also on Cymbalta, a muscle relaxant and pain med that really (does) make a difference with my Fibro, arthritis and osteo pain.”

“Tried Savella, no good. Lyrica did not decrease pain enough to continue. I've used Cymbalta and had good results. Best results have been from using Gabapentin (Neurontin) since 1996, up to 3600 mg daily.”

“I'm back on Lyrica and Cymbalta. I know of the side effects with this medicine but it is the only option that remotely helps.”

The effectiveness of Lyrica and Cymbalta, in particular, has been hyped up with aggressive advertising by their manufacturers. And while research and patient experience show improvement on any of the medications is spotty at best, doctors continue to prescribe them.  This is yet another example where the medical field, in general, has not done a good job in treating, understanding or advocating for fibromyalgia patients.          

Side effects reported by readers to the three drugs include dizziness, mood changes, cognitive issues, swelling, sleep issues, weight gain, increased blood pressure, blackouts and more.  Many of these side effects have a detrimental effect on the daily lives of fibromyalgia sufferers – as if our lives were not difficult enough.

“Lyrica was the worst! I became a sleep-walking zombie. I was so out of it at night that I rarely made it to bed laying down. I would find myself in weird places asleep, such as with my head resting on the faucet in the bathroom sink. Or, I would sleepwalk and fall, like down the stairs. Certainly not good for helping my pain!”

“Lyrica did nothing for me. Cymbalta changed my personality completely. I became mean and hateful. When I asked the (doctor) about it, he's like, yeah that can happen.”

“I have taken Neurontin, Lyrica, Savella, and currently take Cymbalta. Neurontin gave me bad nausea, and the feeling of bugs crawling all over my body. Lyrica made me gain a lot of weight, and didn't help my pain at all. The Savella was the worst for me, it gave me very bad suicidal thoughts, so bad I had to stop taking it, it also never helped with pain.”

If only there was an ideal treatment for fibromyalgia -- one that would offer real relief from the worst symptoms and with few side effects.  But such a treatment could only come with a real understanding about the causes and symptoms of fibromyalgia, and I don’t feel medical research has gotten there yet.

The worst part of my experience with fibromyalgia is trying countless treatments to no avail. And there is nothing worse than being told, as I was, by a medical provider that if you expect real relief, you should also expect side effects and learn to cope with them. That statement shows what little understanding and empathy the medical community has about fibromyalgia, its process, and its difficulties.

I wish I had some good treatment advice to offer, but the fact is, like so many of you, I am exhausted. Years of trying medication after medication has left me weary of the medical community and the companies that manufacture fibromyalgia drugs. 

I have accepted defeat and refuse to try anything new.  Neurontin, Cymbalta, and muscle relaxers offer me some relief from nerve pain, depression, and muscle spasms, so I continue to take them.   Even so, I still live with widespread muscle and tissue pain, and a whole host of other symptoms fibromyalgia brings in its wake.

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.

FDA Bans Use of Codeine and Tramadol in Children

By Pat Anson, Editor

The U.S. Food and Drug Administration is tightening restrictions on the use of codeine and tramadol in young children.

The agency says the opioid medications carry "serious risks" for children under the age of 12, including slowed or difficult breathing and possibly even death. The FDA is also recommending against the use of codeine and tramadol by breastfeeding mothers due to possible harm to their infants.

Codeine is approved to treat mild pain and cough, while tramadol is used to treat moderate pain. Codeine is usually combined with other medicines, such as acetaminophen, in prescription pain medication, as well as in some over-the-counter (OTC) cough and cold remedies. The FDA action only applies to prescription codeine.

"We know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize these medicines much faster than usual, casing dangerously high levels of active drug in their bodies," said Doug Throckmorton, MD, deputy director for regulatory programs, at the FDA Center for Drug Evaluation and Research.

"This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease. Respiratory depression can also occur in nursing babies, when mothers who are ultra-rapid metabolizers take these types of medicines and pass it along to their children through their breast milk."

In a review of adverse event reports from 1969 to 2015, the FDA said it identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18. The agency also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol by children.

The majority of serious side effects with both codeine and tramadol occurred in children younger than 12, and some cases occurred after a single dose.

The FDA is requiring drug makers to add a tougher warning to the labels of codeine and tramadol products, alerting healthcare providers and parents that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12.

The new labeling also cautions against their use in adolescents between 12 and 18 who are obese or have conditions such as obstructive sleep apnea or severe lung disease. Breastfeeding mothers will also be warned not to use the medications.

The FDA said it is considering additional regulatory action for the OTC codeine products that are available in some states. It is also considering an FDA Advisory Committee meeting to discuss the role of prescription opioid cough-and-cold medicines, including codeine, to treat cough in children.

The agency did not recommend or suggest any alternatives to codeine and tramadol to treat childrens' cough or pain. OTC medicines such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) also have risks and side effects.

"We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe," said Throckmorton.

In 2015, the FDA approved the use of OxyContin in children ages 11 to 16  who are in severe pain, a move widely panned by addiction treatment activists who claimed kids would get easily hooked on the painkiller.