Tag Archives: pain

Make Your Voice Heard in Patient-Focused Drug Development

Regular visitors to MedShadow know that as a nonprofit organization, we strive to make the voice of the patient heard more — not only by doctors, but by regulatory agencies, especially the FDA, as well. So I was pleasantly surprised last week to see the FDA publish a statement from Commissioner Scott Gottlieb dealing with “new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making.”

Any effort to give patients more of a say in the development of drugs and medical products, as well as regulatory decisions, is a positive. Gottlieb’s statement was quite long, but the crux of his message, as it relates to patients, follows:

“We must continue to reflect on how we can make the science of drug development and review more modern and more patient-centered, so that approved products impact the metrics that real-world patients and families value most. This requires ongoing engagement with the patient community. Done well, the result is more and more of our review of new medical products benefits from a better understanding of the patient’s experience, providing our reviewers with the critically important context of a disease, and helping them to understand what’s most important to patients related to treatment benefits, risks and disease burden.”

I couldn’t agree more. And as Gottlieb mentioned, the FDA has held Patient-Focused Drug Development (PFDD) meetings in over 20 disease areas, such as opioid abuse, HIV, autism and Parkinson’s. Bravo to the agency for holding these meetings. The agency also came out with reports on what they learned from patients; you can read more about it here.

Next Topic: Chronic Pain

The next PFDD meeting is scheduled for July 9 and will focus on chronic pain. The meeting will be webcast, and you can submit comments related to the meeting through September 10. If chronic pain is an issue for you or someone you love and you have something to say, this is your opportunity to have your voice heard.

While it’s fine to have patient meetings to collect patients’ input, the big question is, will drug developers be listening to and incorporating these patient concerns? It’s hard to say. However, the FDA did issue new guidance for stakeholders to do just this. You can take a look at it here if you like.

The bottom line is that the FDA is giving patients more and more input in the drug development process. If there’s a disease area you are concerned with or have strong feelings about, speak up. It could provide valuable insight for a new drug.

FDA Cracks Down on Online Sellers of Rx Opioids

The FDA is going after 9 companies operating 53 websites for allegedly hawking online unapproved and misbranded versions of opioid medications, such as oxycodone and tramadol.

The FDA has issued warning letters — which order the companies to stop selling the products immediately — to the 9 firms. The agency noted that patients who purchase these substances may be “putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe.”

The illegal online sale of prescription opioids is particularly concerning considering that oxycodone and tramadol have boxed warnings indicating they have a significant risk of serious and potentially life-threatening adverse events. These risks include addiction, abuse and breathing problems.

“The new warning letters are part of a comprehensive campaign to target illegal sales of unapproved opioids,” FDA Commissioner Scott Gottlieb said in a statement. “We’ll be following these actions with additional steps in coming months to crack down on the flow of illegal, unapproved opioids sold online and shipped through the mail.”

In Defense of Pain

Pain is under attack.

The AMA (American Medical Association) wants pain removed as the “fifth vital sign.” Doctors make initial assessments of health based on a list of vital signs: body temperature, pulse rate, respiration (breathing) rate and blood pressure. In the late 1990s pain was added to the list.

The NIH (National Institutes of Health) has convened a task force to discuss pain management best practices. That task force is soliciting public opinion on the use of medicines in pain management. The public comment period is open until June 15.

Most of the concern about overmedicating pain (and thus the debate over considering it a vital sign or not) is motivated by the popular opinion that the opioid crisis is driven in part by the overmedication of pain.

I recently realized that I’d misunderstood the medical designation of pain as the fifth vital sign. I thought what the medical community meant was that pain was a sign to be listened to. “It hurts here,” “It’s a stabbing pain” and “The pain is less” are all very useful information points for doctors. With that information, doctors can diagnose, treat and aid healing, which is their job.

“Ouch,” “I have heartburn” and “My back hurts” are all useful for patients, too. When your gut burns, the message is to avoid hot sauce next time. When an ankle is sprained, pain reminds you to use a cane or keep off it so it can heal, which is your body’s job.

Instead, I have discovered that doctors have interpreted “pain, the fifth vital sign” to mean that a patient should feel only minimal discomfort despite the source of pain. Breathing is a vital sign too, does that mean you shouldn’t have any? Of course, the goal is for the patient to live pain-free, but that’s not really the human condition, is it?

As I type I’m aware that my right wrist is starting to ache. This will encourage me to move from my iPad — with a small keyboard attached — to a more ergonomic desktop station I have nearby. My neck is stiff when I get up in the morning, forcing me to do some stretching exercises so that it doesn’t hurt. Pain is informative and pain can teach us how to avoid injury again in the future.

According to Pain News Network, “Medicare has a funding formula that requires hospitals to prove they provide good care through a patient satisfaction survey known as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS). The formula rewards hospitals that are rated highly by patients, while penalizing those that are not.”

On a scale of 0-10, the HCAHPS leads doctors to try to get patients to a rating of “4” as assessed by the patient. This seems off-point. The reason for pain is not to fight it, but to learn from it. You should hurt after surgery, and lessening pain indicates healing. Having pain reminds the patient to move carefully and allow the body to heal.

One decade of my career was spent as the publisher of a magazine whose readers were childbirth educators. The goal of childbirth education classes (called Lamaze or other names) is to prepare women for labor and delivery. They explain the stages of labor and the purpose of each one. Women and their labor support person (spouse, partner, friend, relative) leave the class with a range of pain coping skills and the knowledge that pain in labor is purposeful and temporary.

The AMA, along with many medical organizations, is calling for an end to the policy that considers pain as the fifth vital sign, and nearly everyone blames it in whole or in part for the opioid epidemic. There is no question that pressure on doctors to have their patients happy and pain-free has driven the overmedicalization of pain response. But don’t blame pain. Pain is only doing its job. We need to do our job and learn from pain.

Do you have something to say about pain management? Comment to NIH’s Committee on Pain Management Best Practices by June 15 here

Quick Hits: New Opioid Withdrawal Treatment, Prices in Drug Commercials & More

The FDA has approved the first non-opioid drug, Lucemyra (lofexidine hydrochloride), to curb opioid withdrawal symptoms in adults. The oral drug is only approved for treatment of up to 14 days, and it may not completely eliminate withdrawal symptoms. The pill may help ease withdrawal symptoms such as anxiety, sleep problems, muscle aches, sweating, nausea, vomiting, diarrhea and drug craving. The FDA indicated that Lucemyra is not a treatment for opioid use disorder (OUD), but could be “used as part of a broader, long-term treatment plan for managing OUD.” Some of the noted side effects include low blood pressure, slow heart rate, sleepiness, dizziness and — in a few cases — fainting. The FDA is requiring the drug to undergo further testing in teens and newborns of mothers addicted to opioids, and potentially for longer use in people weaning off opioids. Posted May 16, 2018. Via FDA.

The FDA is beginning to explore whether drug companies should list product prices in commercials. At a forum in Washington, FDA Commissioner Scott Gottlieb said that the agency is looking into whether it has “the ability to compel this kind of speech under the current regulations.” The discussion also focused on another important question: Which price should drug companies disclose? Gottlieb acknowledged that the list price may not serve as a good indicator of what a consumer would actually pay at the counter because of rebates, discounts or insurance coverage, which typically reduce the drug’s list price. Gottlieb noted that the agency will explore which price system is best moving forward. Posted May 15, 2018. Via Modern Healthcare.

Colorado is looking to curb opioid abuse by limiting prescriptions to a 7-day supply. A new bill in Colorado’s General Assembly would restrict the number of opioid pills a healthcare practitioner — including, but not limited to, physicians, nurses, dentists and veterinarians — may prescribe. The limit is a 7-day supply on an initial prescription, and a refill for a 7-day supply, with some medical exceptions. Also, the 7-day limit is only applicable to the initial prescription for acute pain, not for chronic pain or cancer-related pain. Posted May 16, 2018. Via Colorado Public Radio.

Corticosteroid Adverse Events Risk Increases With Longer Use

Using corticosteroids for the long term may increase the risk of adverse events compared to occasional use, according to a new study published in the journal Current Medical Research and Opinion.

Researchers collected data from a privately-insured administrative database where they analyzed 78,704 patients who were diagnosed with an autoimmune or inflammatory disease between 2006 and 2015. Analysts looked at patients who used corticosteroids occasionally (60 days or less) and those who used the inflammatory medication for an extended period of time (longer than 60 days). Of the 78,704 patients, 9.5%, 11%, and 8.6%, respectively, were classified as high-, medium- and low-dose extended corticosteroid users.

Hypertension, pneumonia and osteoporosis were the adverse events with the highest incidence rates.

The authors wrote, “For most adverse events, all levels of corticosteroid use exhibited significant risks of increased incidence compared to intermittent use.”

What Doesn’t Work for Arthritis

I just sat on a panel for the FDA to discuss a study that compared the safety profiles of 3 NSAIDs: Celebrex (celecoxib), Aleve (naproxen) and Advil (ibuprofen). All NSAIDs (except aspirin) are proven to increase the risk of cardiovascular (CV) events (heart attack, stroke, myocardial infarction, etc.) which is why they must be used sparingly and carefully by anyone with increased heart or stroke risk. The study was designed to prove that celecoxib didn’t kill or harm more people than naproxen and ibuprofen.

After reading hundreds of pages of studies and listening to a full day of presentations and community input, I learned something: If I ever have arthritis pain or any chronic pain, I will NOT be using celecoxib, naproxen or ibuprofen.

The medical community is concerned that celecoxib might substantially increase the risk of CV events — even more than naproxen and ibuprofen. Celecoxib is also known as a COX-2 inhibitor, just like Vioxx (rofecoxib) and Bextra (valdecoxib), both infamously withdrawn from the market after reports surfaced of people having serious — and sometimes deadly — CV events after taking the medications.

The PRECISION Trial that we discussed at the FDA meeting was designed to determine if Celebrex was “non-inferior” to naproxen and ibuprofen. The study was flawed and only tested celecoxib at comparatively low levels. Vioxx and Bextra were more dangerous as the dose increased.

At low levels (100 mgs 2 times per day), Celebrex actually looked safer than naproxen and ibuprofen. My question: Would doctors have the restraint to not increase the FDA-recommended dose in the face of those patients who continue to have pain? Celebrex’s prescribing information states: “For management of acute pain and treatment of primary dysmenorrhea, the dosage is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.”

And many of those patients will have continued or breakthrough pain while using any of the 3 NSAIDs because they only work in about 30% of people and lower the pain amount by just 30%, according to a meta analysis (study of studies) conducted by Harvard University on OA knee pain. Ultram (tramadol) and stronger opioids were found to be just as ineffective, with about a 30% drop in pain.

During the PRECISION trial of people with RA and OA pain, about 70% of the people dropped out, which is in alignment with the low level of effectiveness. In the study, 24% of trial participants said the reason they dropped out was because the “adverse events” (side effects) were so severe that they couldn’t continue. Changes in diet and exercise have been proven to be very effective in managing the disease — and without the side effects of COX-2s and NSAIDs.

My recommendation to the FDA was that all 3 — celecoxib, naproxen and ibuprofen — should have a warning on the package that they should not be used for long-term or chronic pain because they are ineffective, have too many side effects and increase the risk for CV.

Got Chronic Pain? Cognitive Therapies May Provide Relief

Elderly people living with chronic pain may find some relief if they treat it with psychological interventions, such as cognitive behavioral therapy (CBT), according to a study published in JAMA Internal Medicine.

Researchers looked at 22 studies that evaluated 2,608 participants undergoing psychological interventions. The results indicated that psychological interventions proved effective for many adults battling chronic pain. CBT methods reduced their pain, minimized their catastrophic thinking and improved their self-efficacy, equipping them with the confidence to successfully manage their pain.

Even though many of the studies didn’t evaluate the long-term effects associated with the psychological therapies, this study still demonstrates the benefits that come with the treatment, the authors say.

Is Kratom as Dangerous as the FDA Claims? It’s Hard to Tell

MedShadow occasionally runs “First Person” articles that give personal perspective on a particular drug, supplement, medical or health issue. The one we ran last Thursday, which dealt with a Navy vet’s experience using the herb kratom, has generated a lot of attention on MedShadow’s Facebook and Twitter pages.

If you haven’t read the piece by Andrew Turner, I highly suggest you do. Mr. Turner not only discusses how kratom has helped alleviate pain he sustained from an injury incurred during his military service, but he also takes the FDA to task for condemning the herb without consideration of the experience of millions of patients — the American Kratom Association says 3 million Americans are regular users — who have been helped by this naturally occurring substance.

And in the spirit of transparency, in a February news release, FDA Commissioner Scott Gottlieb said that the agency has received reports of 44 deaths associated with kratom. The agency has also expressed concern about the herb’s opioid-like qualities. And over the last month, it has issued several recalls of kratom products over possible salmonella contamination.

We heard from other kratom users, some of whom said the herb was a lifesaver for them. And others — who may or may not be kratom users — criticized the FDA for trying to ban a supplement that has helped a good number of people.

The debate over kratom has heated up over the last 6 months or so. And throughout this time, I have wondered whether kratom is really potentially dangerous. At the same time, I’ve wanted to know what the evidence is on the herb’s medical usefulness, and what the research says.

Since the publication of Mr. Turner’s article, I’ve done some digging of my own. The bottom line: I came across sources that support kratom’s medical benefits — and an equal number that warn of the dangers of the herb.

One article that caught my eye was from WCPO in Cincinnati. In it, a woman, who happens to be a recovering drug addict, tells how she used kratom — instead of the opioid painkiller Percocet her doctor prescribed — to manage pain associated with a C-section she had. The reporter also interviewed a researcher who supports the use of kratom.

Oliver Grundmann, PhD, with the University of Florida College of Pharmacy, said that even though kratom interacts with opioid receptors in a similar way that opioid pain drugs do, the effects the herb and the opioid meds have on the body are different.

He noted that kratom, unlike opioids, doesn’t influence breathing, which reduces the chances of an overdose. And while Grundmann admitted there are potential adverse effects with kratom, he’s not convinced it is responsible for those 44 deaths.

In medical literature, a recent review published in the February issue of the journal Drug and Alcohol Dependence piqued my interest. The piece, on kratom and mental health, found the herb has “potential as a harm reduction tool, most notably as a substitute for opioids among people who are addicted.”

This made me wonder, did the FDA consider this use of kratom before issuing its February warning?

To be fair, I also found interviews with other researchers and doctors, as well as other journal articles, sounding alarm bells about kratom.

In a perfect world, we would have a clear answer on kratom’s risks and benefits. Unfortunately, we are not there yet. If you take kratom or are thinking of taking it, please do your own research and discuss any questions or concerns with a medical professional – or two.

While I understand the FDA has a duty to inform the public about concerns it has about kratom — or any other supplement or drug, for that matter — they also have an obligation to fully vet the research before coming to a firm conclusion. My fear is that they decide to ban kratom without having a more complete understanding of kratom’s risk/benefit profile. Were that to happen, it would be a disservice to patients who find kratom to be a valuable therapy that has allowed them to lead a better life.

The FDA Has It Wrong on Kratom: How the Herb is Helping People Like Me


By Andrew Turner
Some may ask who are the consumers of kratom, an herb used to treat pain, depression and anxiety that has been the subject of controversy lately in the news. It’s complicated.

We can be anyone. We are your neighbor, the veteran in the supermarket, your college professor and even your best friend. There’s a lot of misconceptions about kratom, how it’s used to treat certain ailments and its potential for addiction.

Some incorrectly assume that anyone taking kratom must have been a drug addict before. The reality is most people are taking kratom to supplement their health.

For me, this path to kratom came after trying a number of conventional health options. For many years, I was prescribed a multitude of medications to address all sorts of service-related injuries and illnesses. When my doctors diagnosed me with a rare movement disorder called Meige Syndrome and tried to treat it with limited options, I lost several years of my life due to disability.

For many like me, trapped in a no-win situation with a severe physical or mental disability, you accept that conventional science has not funded research on many rare diseases and you seek other solutions. The path that I was on was not sustainable and too often has led many veterans like myself to take their own lives. I was fortunate that, again, I found an educated doctor, someone who had seen the signs before. My doctor realized that the medications that I was on at the time were doing very little for me — they were not providing me a good quality of life and may have actually been causing more harm than good.

My doctor took me off the medications that weren’t helping and suggested that I “just look into some natural options that will provide you some quality of life. That may be all we can do in your situation.”


Watch Andrew Turner on CBS This Morning, 4/3/2018

Strangely, in my search some 3 years ago, I kept reading people talking about kratom, a plant with medicinal benefits, including relief from pain, depression and anxiety.

I spent many nights reading about this and every time I would read more the only thing I could think was this must be snake oil. I couldn’t imagine some simple plant I’ve never heard of from Southeast Asia could help me in such a phenomenal way. But then I read studies that support the medical use of this incredible herb. (Here’s a review that came out in December that looked at 57 studies of kratom).

The first time I took kratom I can’t say I experienced anything — its effect is subtle. So I was initially still convinced it was nothing but snake oil and I had been duped. But because I had so few options and conventional medication did not help, I stuck with it.

It was a few weeks after I had tried several types of kratom (both in a tincture form and in a ground raw leaf form) when I started to notice something was different. It had an incredibly calming effect, I was sleeping better and my overall well being had changed dramatically. Now 3 years later, I start my day with a cup of kratom tea. I prefer it cold with plenty of lemon or lime juice and just a bit of raw honey.

Now this is not a treatment nor a cure for my physical and mental disabilities. To be able to claim that, substantial sums of money would have to be invested by the pharmaceutical industry so that kratom could undergo clinical trials. I understand my experience may have caused interesting changes to my health, but it may not work for someone else.

FDA Commissioner Scott Gottlieb has said publicly that what I’ve experienced is impossible. I’ve learned that I’ll just accept what he has to say and at the same time I will enjoy my kratom tea. My life has changed so much that I’ve even been able to dedicate myself to almost full-time advocacy work on behalf of kratom.

Now you may ask, “What happens if you stop taking kratom?” and for me, over time I would lose a lot of the ground that I have gained. On a daily basis I have to then fight for my right to have some quality in my life. The one question I have for anyone who supports a ban of plants like kratom or marijuana or dandelions is: Do you feel people deserve to have quality of life or not?

Everyone deserves the right to make decisions about their quality of life. Sometimes to achieve that means allowing things that others are uncomfortable with. Maybe someday folks like Gottlieb will sit down with a kratom consumer like me and say, “You don’t deserve to enjoy the same quality of life I do” and at that point better understand that what is OK for me but not be for thee.

For now I will continue to wake up each day and start with my kratom tea and fight to #KeepKratomLegal for as many days as I have left on this planet. Kratom isn’t perfect. I know that, but it’s perfectly good for what I need. For several years now, I and others have had to fight almost daily to protect our quality of life. That’s a fight worth being in and one that I always say isn’t over no matter what the FDA says.

Can the Pain Without the Meds: 8 Non-Pharma Therapies

“When your whole body is a giant toothache, nothing fixes it,” observes Charley Pavlosky, 62, recalling the systemic pain that plagued him 11 years ago. A lifelong athlete, he was familiar with the aches and pains of being active – he’d even had surgery to repair a disc – but this was new to him.

His chronic pain was so severe that he was only getting 2 hours of sleep a night, and during the day he experienced anxiety and panic attacks. The Santa Barbara, Calif., resident found a comprehensive nonpharmaceutical pain management program developed by spine surgeon David Hanscom, MD, author of Back in Control: A Spine Surgeon’s Roadmap Out of Chronic Pain.

With the exception of a temporary prescription for Ativan (lorazepam) to help him sleep, Pavlosky began to create a pain-reducing lifestyle. Pavlosky was mostly pain free within 6 months of working on sleep hygiene along with cognitive behavioral therapy (CBT) and twice-daily expressive writing techniques. Then he gradually weaned himself off the Ativan. He also eats a whole foods diet, stays physically active, drinks plenty of water, and allows himself a massage as needed.

Pavlosky is one of the estimated 100 million adults who live with chronic pain, a condition that costs the United States between $560 and $630 billion annually in healthcare expenses and lost productivity, according to the American Academy of Pain Medicine.

People living with pain may be offered surgery or medications from numerous classes of drugs, including corticosteroids, muscle relaxants, anticonvulsants, antidepressants, opioid pain medications and more.

The landscape of pain management is changing rapidly, as legislatures and federal health agencies seek to more tightly control and monitor opiate pain medication prescription practices. These changes are in response to an increase in prescription pain medications – which quadrupled nationally between 1999 and 2014, according to the Centers for Disease Control and Prevention. Pain remains one of the leading reasons that people seek medical care.

“When we’re treating people with pain, are we treating suffering, or are we treating pain? The expectation of being pain free is an unrealistic expectation for the patient and the doctor,” says osteopath Doug Jorgensen, DO, founder of Patient360, a physician registry firm. Jorgensen observes that for the past 2 decades the trend has been to try to provide medication that would mask pain as much as possible.

“What medicine has done is, we keep throwing simplistic solutions at a complex problem. As the awareness of the complexity of pain grows, we believe in treating every aspect simultaneously,” says Dr. Hanscom, who lived with intense chronic pain for 15 years before developing his multilayered approach to pain management. Dr. Hanscom is in private practice with Swedish Neuroscience Specialists in Seattle.

The complexity of Hanscom’s program reflects the recommendations for non-pharmaceutical pain management outlined by the American College of Physicians clinical practice guidelines and in the Academic Consortium for Integrative Medicine & Health Pain Force White Paper published in 2017.

People with chronic pain might still need medications or surgery. These 8 strategies can be used on their own or with other medical treatments to reduce pain:

  1. Acupuncture. Nurse practitioner Elizabeth Spokoiny, DPNC, RN, on staff at the University of Washington Medical Center in Seattle, found relief from pain with acupuncture after a car accident in 2015, and then was able to tackle 20 years of pain caused by an autoimmune condition. In addition to acupuncture, she uses dietary change, meditation, bodywork and yoga to manage pain. Her experience with acupuncture is mirrored by clinical data. A research review published in a 2017 issue of Programme Grants for Applied Research showed acupuncture to be more effective than a placebo or no treatment.
  2. Massage therapy. At least an hour a week of massage therapy or other soft tissue manipulation could improve your experience of pain. Massage is recommended by the American College of Physicians Clinical Practice Guidelines for acute, subacute and chronic pain.
  3. Meditation, relaxation and biofeedback. These are practices that connect your mind and your body despite pain, and are recommended by the ACP. “My first experience with chronic pain was 40 years ago, when I was 25 years old,” recalls biofeedback practitioner Cindy Perlin, LCSW, author of The Truth About Chronic Pain Treatments: The Best and Worst Strategies for Becoming Pain Free, in private practice in Albany, N.Y. “I also use exercise, nutrition, homeopathy, energy psychology, occasional massage, self-massage and, most recently, low-level laser therapy to deal with pain challenges that come up.”
  4. Yoga, tai chi and Pilates. Although pain can make you want to be still, movement can also reduce pain. “Movement causes us to produce endorphins, which are naturally occurring opioids,” says integrative medicine pain specialist Heather Tick, MD, associate professor of anesthesiology and pain management at the University of Washington in Seattle.
  5. Nutrition. Make sure your plate offers a rainbow of fruits and vegetables. “Most people don’t know that everything you eat can impact your body chemistry,” says Dr. Tick, lead author of the Consortium’s white paper. She recommends giving up sugary, fatty, processed foods. Instead, aim for the anti-inflammatory eating pattern outlined by the Academy of Nutrition and Dietetics. This approach emphasizes eating produce, whole grains, heart-healthy fats, plant-based proteins or fish, and fresh herbs as seasoning. Dr. Tick also advocates certain supplements, such as magnesium, vitamin D, fish oil and turmeric (curcumin).
  6. Hands-on manipulative therapies. Massage, osteopathic treatment and chiropractic treatments all are evidence-based approaches to pain management.
  7. Challenge your thoughts. CBT is an approach that helps identify harmful thought patterns and provide alternative thoughts, while also identifying and supporting your resilience. CBT has been shown to help with many aspects of pain management, according to a review of research published in the February issue of Physical Therapy.
  8. Sleep better. The relationship between pain and sleep is dynamic: Pain interferes with getting the sleep you need, and sleep deprivation makes pain feel worse. Taking steps to improve the quality of your sleep will be part of your pain management strategy. Pavlosky stresses the value of being more mindful about quality sleep habits. “I don’t look at screens for at least an hour to 2 to 3 hours before sleep. I dim the lights after sundown, so my body can slowly start preparing. I don’t have any coffee or caffeine after noon and no alcohol late at night,” he says.

Finally, whether you opt for any of these approaches, or medication or surgery, make sure your expectations for pain relief match up with the reality of the treatment, advises Sal Raichbach PsyD, LCSW of Ambrosia Treatment Center. Raichbach recommends a substantial conversation so that you and your physician understand both your hopes for pain relief, as well as what you might expect from any given mix of therapies.

Need to Know: NSAIDs

NSAIDs (nonsteroidal anti-inflammatory drugs) are some of the most commonly used pain relievers and can either be prescribed by your doctor or purchased over the counter (OTC). They’re used to treat a wide range of illnesses, from arthritis to headaches to sprains to postsurgical pain. Like any medication, NSAIDs can cause side effects, some of them serious.

Common Names

Aspirin (Bayer, Bufferin, etc.), ibuprofen (Advil, Motrin, etc.), naproxen sodium (Aleve, Anaprox, Naprosyn), celecoxib (Celebrex), fenoprofen (Nalfon), indomethacin (Indocin), oxaprozin (Daypro), piroxicam (Feldene), diclofenac (Voltaren), salsalate (Disalcid)

How They Work (Method of Action)

NSAIDs block proteins called cyclooxygenase enzymes (COX enzymes) that help make prostaglandins, hormone-like chemicals that cause pain by activating the inflammatory response. Blocking COX enzymes decreases the level of prostaglandins, reducing pain. NSAIDs also lessen inflammation like swelling, redness and fever.

Side Effects and What to Do About Them

The most common side effects of taking NSAIDs are stomach issues like irritation, pain, heartburn, gas, bloating, constipation and diarrhea. These side effects can usually be relieved by taking your NSAIDs with food or milk or by also taking antacids such as Mylanta or Tums. Dizziness, mild headaches, problems concentrating, balance issues and lightheadedness are also common.

More serious side effects can include high blood pressure, ulcers, allergic reactions, retaining fluid (which can cause swelling in the face, hands, lower legs, feet or ankles), bloody or cloudy urine, rashes, blurry vision, jaundice, exhaustion, difficulty breathing, ringing in the ears, vomiting blood, weakness in one side of the body, light sensitivity, extremely painful headache or back pain, a change in balance or ability to think clearly, chest pain and faster heartbeat. Let your doctor know right away if you experience any of these.

The FDA strengthened its warning about non-aspirin NSAIDs in 2015, saying they can increase the risk for heart attacks and strokes, even in the first weeks of use. The increased risk of heart attack or stroke still applies if you don’t have heart disease, though the risk is generally higher for those with heart disease or risk factors for heart disease.

User Experiences

Rick Schneider, 52, used aspirin for most of his life, but when ibuprofen became available over the counter, he started taking that instead. “After two wrist surgeries, I found that the relief gained from ibuprofen was the same as that from narcotic pain tabs, or better,” he says. He also notes that even though he has Crohn’s disease, he hasn’t had any bad effects from taking either ibuprofen or aspirin.

When Laura Swanson, 34, has to work, she takes anywhere from 4 to 8 ibuprofen to help reduce the aches and pains she gets from being on her feet all day, as well as to help with her idiopathic pressure urticaria (hives), which doesn’t respond to antihistamines or steroids. She notices that she bruises more easily on the days she takes ibuprofen, and she tries not to take it when she’s home so she doesn’t overwhelm her kidneys and liver.

Pam Nielsen, 55, is a big fan of ibuprofen and says it’s her go-to for pain and inflammation. Years ago, an OB/GYN nurse told her that taking 4 to 5 at a time every 4 to 6 hours would slow down her bleeding and her horrendous monthly cramps, so for years, she took it that way on the days in her cycle when she couldn’t function. “For me, it works miracles,” she says. She has never had any issues with side effects.

Gail Stoltenberg, 42, is on Voltaren (diclofenac), a type of NSAID, and Motrin (ibuprofen), along with a couple of other medications, for her psoriatic arthritis, ankylosing spondylitis and a central nervous disorder. She uses the ibuprofen as needed for inflammation and says sometimes it helps, but not very often. Her doctor put her on diclofenac, which gives her some relief, but not 100%. However, when she has tried to go off of the diclofenac, her psoriatic arthritis flare-ups have gotten worse.

Drug Interactions

NSAIDs may interact with other medications, which can make them less effective. Talk to your doctor before taking any NSAIDs, whether prescription or OTC, if you’re on any medications that treat high blood pressure, diabetes, heart disease or arthritis; or that thin blood or are immunosuppressants, such as (but not limited to) warfarin (Coumadin), clopidogrel (Plavix), cyclosporine (Neoral or Sandimmune), phenytoin (Dilantin), corticosteroids, lithium and probenecid. Also let your doctor know about any other prescription or over-the-counter medications, vitamins, supplements or herbs you’re taking.

Effectiveness and Considerations

NSAIDs are relatively safe for healthy individuals who use them occasionally, and they are often very effective at preventing pain and inflammation. Long-term use and taking higher doses of NSAIDs can increase the likelihood of side effects.

Be sure to use only the lowest dose you need for effectiveness, and only increase it if that doesn’t work. Once your pain is manageable, try other pain relief methods such as cold or warm compresses or a hot bath to give your system a break from the NSAIDs.

Studies consistently show that NSAIDs are just as effective as, and in some studies, more effective than, opioids for relieving pain. The fact that they have far fewer side effects without the risk of dependency that opioids do makes them a good choice for postoperative and chronic pain.

Alternatives to NSAIDs

If you have chronic pain, there aren’t many alternatives to NSAIDs since they are so effective. However, to reduce risks, try taking the lowest dose you can while still maintaining some relief, especially if you have heart disease. You can also incorporate exercise, weight loss, physical therapy and hot or cold therapy for natural pain relief.

If you have arthritis, you can try acetaminophen (Tylenol) for pain relief, though it won’t help much with inflammation. Antidepressants and anticonvulsants are another alternative to help pain relief, though they come with their own set of risks. As with chronic pain, you can also add physical therapy, massage, acupuncture, joint-supporting splints, exercise and weight loss to help manage your pain. Topical agents such as Bengay, lidocaine patches and Icy Hot can also relieve pain due to arthritis.

Transcutaneous electrical nerve stimulation (TENS) units electrically stimulate nerve and muscle fibers to relieve pain and have been shown to be effective for some people, though they are better for chronic pain than for acute pain.

Is Kratom Really As Dangerous As the FDA Makes It Out to Be?

America is in the midst of one of the worst epidemics in its history over opioids, which may be one of the reasons the FDA recently issued a warning that kratom, a plant-based supplement often used for pain, is potentially addictive since it has opioid-like qualities.

Kratom has also been used by some people to treat withdrawal from opioids. However, the agency stated that there is “no reliable evidence” to support this and “significant safety issues exist.” The FDA also said it has received reports of 44 deaths related to kratom use. However, as a recent Reason.com blog pointed out, in many of these cases, other substances were found along with kratom in the systems of the deceased, making it difficult to prove kratom was the cause of death.

In one of those deaths, a 22-year-old man had a cocktail of drugs in his system that included the antidepressant Prozac (fluoxetine), antipsychotics Seroquel (quetiapine) and Zyprexa (olanzapine), Lyrica (pregabalin), which is used for nerve pain, and several benzodiazepines (tranquilizers) – in addition to kratom. Also, as Jacob Sullum argued in another Reason.com blog, more people have died from prescription and over-the-counter pain relievers than kratom.

So is kratom really as dangerous as the FDA makes it out to be?

It’s hard to say. But it may be harder to get your hands on kratom. The FDA has already blocked importation of the substance. And in 2016, the Drug Enforcement Agency (DEA) ruled to classify kratom as a Schedule 1 drug, putting it in the same class as marijuana, LSD and heroin as substances with no currently accepted medical use and a high potential for abuse. The DEA backpedaled a bit later in the year following outcry from the public. However, the FDA’s warning could make it more likely for kratom’s Schedule 1 designation to go through.

To me, it seems the FDA is making a bit of a rash decision. Although the FDA says it conducted its own medical analysis of kratom, there is a lot of existing research supporting kratom as effective for conditions such as PTSD and depression. Did they consider this before issuing a warning?

Much like the FDA’s and DEA’s position on marijuana, it seems that decisions are being made based on incomplete examinations of the positives and negatives of herbal substances. The FDA and DEA owe it to patients who use kratom and find benefit from it to conduct a more thorough investigation before deeming it unsafe for public consumption.