* opioid;

New Strategy Almost Halves Opioid Use in Surgical Cancer Patients

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A new approach almost halved the use of opioid analgesics in surgical oncology patients without increasing their pain or anxiety.

The two-prong approach included maximizing the use of over-the-counter nonopioid therapies and changing the nature of postsurgery discussions with patients. The result was a 46% reduction in opioid use.

These findings will be presented at the American Society of Clinical Oncology’s (ASCO’s) upcoming Quality Care Symposium.

“While opioids can be an effective pain management tool for cancer patients, there is a risk of addiction, particularly for people who have recently undergone surgery,” said lead author Kerri Stevenson, NP, Stanford Health Care, California, in an ASCO press release.

“We found that when you have conversations with patients about pain control, including nonopioid therapies available and the potential risks associated with opioids, they appreciate being involved in their own care and, subsequently, have a reduced need for opioid medications,” she said.

Opioid overuse and misuse have become a top public health concern. Recent data suggest that the situation is getting worse rather than improving, as reported by Medscape Medical News. In 2016, more than 40,000 Americans died from opioid overdose. For many individuals, the first encounter with opioids comes when opioids are prescribed for acute pain management following surgery. An estimated 6% of patients who are not regular users of opioids become newly addicted to these medications post surgery. One recent study found that 10% of cancer patients who underwent curative surgery were still filling opioid prescriptions 1 year after the procedure.

Use Reduced by 46%

In the latest study, Stevenson and her colleagues aimed to reduce reliance on opioid medications in managing postoperative pain by 50%, from a baseline morphine equivalent daily dose (MEDD) of 95.1 to a target MEDD of 47.5.

The authors retrospectively reviewed daily opioid use, pain scores, and anxiety scores for inpatients recovering from surgery for urologic cancers at a high-volume surgical department during a 4-month period. They then used these data to design a “two-pillared” strategy.

The first pillar was focused on developing care pathways for postoperative pain control utilizing nonopioid medications and therapies as first line. This included designing opioid-sparing pain regimens, using varying combinations of acetaminophen, ketorolac, gabapentin, and local anesthetics, and identifying key drivers that were needed to reliably decrease excess opioid use. Providers and nurses were educated about the availability and efficacy of the treatment plans, and although patients were still prescribed opioids, prescribing was at lower doses, and dosing was only escalated if necessary.

The second pillar involved changing postoperative conversations with patients. For example, instead of nurses routinely asking patients whether they needed pain medication (referring to opioids), they instead discussed the current nonopioid medications patients were receiving for pain, along with frequency and dosage, and asked whether this was sufficient. Potential side effects of opioids were also discussed with the patients.

A total of 443 surgical patients were included in the cohort. During the study period, the median opioid use per patient dropped by 46%, from 95.1 to 51.5 MEDD. The decrease in opioid use was observed across multiple procedures.

Importantly, there was no increase in 24- or 48-hour postoperative pain scores associated with the use of opioid-minimizing pathways.

The authors also noted that there were no changes in anxiety scores 24 or 48 hours after surgery.

Experts Weigh In

“New approaches for using appropriate amounts of opioids are crucial now, given the increased public attention given the opioid crisis,” commented William Dale, MD, PhD, chair, Supportive Care Medicine, the City of Hope, Duarte, California. “There has been tension in the cancer world about this, and we don’t want to cut off the ability for patients to get pain relief. So the question is, how do we go about optimizing the use of opioids while minimizing the risk?”

There has been tension in the cancer world about this. Dr William Dale

The patient cohort used in this study was an “interesting population” in that the patients were completely opioid naive, Dale commented to Medscape Medical News. “This kind of program shows that it can be done through the use of other types of medications and discussions with providers,” he said.

One caveat is that alternate medications also have a risk/benefit profile and may have their own side effects. “It’s a matter of customizing the options and not just eliminating one or another,” he said. “There are multidisciplinary methods of managing pain, and opioids don’t have to be used for everyone and in every situation. The bottom line is to evaluate the risk and if they are needed, to use them in a thoughtful way.”

Another expert who was contacted for comment noted that these results are useful in two ways. “One is that we do know that a small percentage of patients will end up addicted to opioids,” said Michael S. Sabel, MD, FACS, associate professor of surgery and chief of surgical oncology, the University of Michigan, Ann Arbor. “And we see here is that it is not always necessary to give patients a large amount of opioids.”

The second is that reducing opioid use also keeps the drugs out of the community, he explained. Even though there are many sources and ways for people to obtain opioids, prescriptions that patients fill and then end up not using can inadvertently fall into the wrong hands.

“We don’t want to reduce opioids and have patients in pain,” Sabel said. “But this study shows that use was reduced almost by half, and so that lowers the risk of addiction and reduces the number of pills out in the community.”

The interventions used in this study can also help guide patients once they return home. “If you can decrease use in the hospital, then it is likely use will be decreased once the patient is discharged,” he added.

FDA revises labelling to contain opioid use in cough products in kids

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https://speciality.medicaldialogues.in/fda-revises-labelling-to-contain-opioid-use-in-cough-products-in-kids/

A Shocking Decline in American Life Expectancy

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For the first time since the early 1960s, life expectancy in the United States has declined for the second year in a row, according to a CDC report released Thursday. American men can now expect to live 76.1 years, a decrease of two-tenths of a year from 2015. American women’s life expectancy remained at 81.1 years.

The change was driven largely by a rising death rate among younger Americans. The death rate of people between the ages of 25 and 34 increased by 10 percent between 2015 and 2016, while the death rate continued to decrease for people over the age of 65.

Life Expectancy By Age

The only racial group that saw a significant increase in their death rate between 2015 and 2016 were black men: Their age-adjusted mortality rate increased by 1 percent.

“What you see this year is a leveling off of the gains that we’ve had over the years, especially with heart disease and cancer,” among black men, said Garth Graham, the president of the Aetna Foundation and former head of the U.S. Office of Minority Health. “And the opioid epidemic is starting to overtake whatever gains we’ve made in that sector.”

Age-Adjusted Death Rate, By Race And Sex

The rise in young American deaths has been fueled by fentanyl overdoses. Unintentional injuries, a category that includes drug overdoses, became the third leading cause of death in 2016, after heart disease and cancer. In 2015, it had been the fourth-leading cause.

In 2016, more than 63,600 Americans died of drug overdoses, according to another CDC report released Thursday, or 21 percent more than in 2015. The overdose rate was highest among men and people under 55.

Age-Adjusted Drug-Overdose Death Rates, By Opioid Category

Because that number is likely an underestimate, Keith Humphreys, an addiction specialist at Stanford University, toldThe Washington Post that “even if you ignored deaths from all other drugs, the opioid epidemic alone is deadlier than the AIDS epidemic at its peak.”

Scientists design a drug that relieves pain like an opioid without some dangerous side effects

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What if you could design a drug that has all the pain-relieving power of morphine but none of its dangerous or addictive side effects?

Scientists have spent years trying to do just that, and on Wednesday, they unveiled one of their most promising compounds yet — a chemical concoction they dubbed “PZM21.”

When tested in mice that were placed on a hot surface, PZM21 offered nearly as much pain relief as morphine and lasted for up to three hours. That’s “substantially longer” than morphine or other experimental drugs, the scientists wrote in the journal Nature.

Mice treated with PZM21 did not find it addictive, as evidenced by the fact that they were no more likely to return to a place where they got the drug than to visit a similar chamber where they could get a saline solution. Plus, while the animals became hyperactive after a dose of morphine — considered a sign of the drug’s addictive power — they remained perfectly calm after getting a comparable dose of PZM21.

They also were less constipated, a side effect of opioid drugs that was highlighted in a much-maligned Super Bowl commercial.

But the drug isn’t perfect. Like morphine and other opioids, PZM21 caused mice to slow their breathing to dangerously low levels. However, their breathing improved before the drug’s painkilling properties wore off. That’s in contrast to morphine, which continues to cause respiratory depression even after it allows pain to return.

The researchers, led by Dr. Aashish Manglik of the Stanford University School of Medicine and Henry Lin of UC San Francisco, found their way to PZM21 by searching for a compound that would precisely fit a specific type of opioid receptor in the brain and spinal cord. They used powerful computers to test more than 3 million compounds, each in an average of 1.3 million configurations.

The top 2,500 contenders — representing 0.08% of the possible candidates — were checked manually. Among these, 23 were selected for further testing, of which seven were deemed most promising. The researchers then tested 500 analogs of three of them and narrowed the field to 15, then seven, then finally one.

But they weren’t done. They tweaked this compound, rearranging the atoms in the molecule to get the best possible fit. Their creation was PZM21.

In the tests with mice, the higher the dose of PZM21, the more pain relief they felt. Ultimately, the compound ameliorated 87% of their pain, compared with 92% for morphine, according to the study.

Although their computer-assisted approach wasn’t able to find the optimal drug — one that had no effect on breathing — it did allow the researchers to create something that is tantalizingly close.

The need for such a drug is clear. According to the Centers for Disease Control and Prevention, sales of prescription opioids like morphine, OxyContin and Vicodin have quadrupled since 1999, and so has the number of overdose deaths. By 2014, the number of annual overdose deaths in America reached 14,000. The drugs send more than 1,000 people to U.S. emergency rooms every day.

“An ideal opioid would kill pain potently without producing morphine’s harmful respiratory effects, would show sustained efficacy in chronic treatments and would not be addictive,” molecular biologist Brigitte Kieffer, an expert on opiate receptors, wrote in anessay that accompanied the Nature study.

PZM21, she added, represents a step “toward this perfect drug.”

Painkillers are Killing So Many People, Morgues Are Literally Overflowing

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HHL_july14_10

More than 28,000 Americans died from opioid overdoses in 2014 — more deaths than any other year on record, according to data from the U.S. Centers for Disease Control and Prevention (CDC).

The number includes deaths from both heroin and prescription opioid pain relievers, but the latter accounted for at least half. The epidemic, which, by the way, is the CDC’s own term for this increasingly alarming trend, appears to only be getting worse.

Since 1999, opioid overdose deaths quadrupled, as did the amount of prescription opioids sold in the U.S. All of these pain relievers did not equate to equal amounts of pain relief, however, as Americans reported pain levelsstayed steady during that time.

Meanwhile, death rates from overdoses of oxycodone, hydrocodone, methadone and other prescription opioids also quadrupled since 1999. In some areas, such deaths are becoming so commonplace they’re overwhelming coroner and medical examiner systems.

Some Areas Are Looking Into Renting Refrigerated Trucks to Store Bodies

In Connecticut, the chief medical examiner has considered renting a refrigerated truck to store bodies because the storage space at the medical examiner’s office is often maxed out.

The space shortage is attributed to rising drug overdose deaths, including opioid overdoses, which are pushing many medical examiner and coroner offices to their limits.

In areas like Cincinnati, Ohio, forensic pathologists responsible for conducting autopsies on many such victims may conduct more than 325 autopsies this year alone.

The National Association of Medical Examiners’ (NAME) accrediting program puts the limit at 325 a year, and offices that conduct more risk losing accreditation.

Some coroner’s offices are also facing backlogs of DNA testing for drug investigations, again in large part due to overdose deaths. Dr. David Fowler, Maryland’s chief medical examiner and president of NAME, told STAT News:

“There are many, many parts of the country that have substantial problems … I think the drug overdoses have substantially increased the problems.”

Opioid Use Among Seniors Soars

oxycodone

The opioid epidemic has touched lives both young and old. A new report from the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) revealed that seniors take the drugs at an “astounding” rate.

About 12 million Medicare beneficiaries, or about 1 in 3, received at least one opioid painkiller prescription in 2015, totaling $4.1 billion. Among those taking the drugs, most received more than one prescription or refill; the average was actually five opioid prescriptions or refills per opioid user.

The most popular opioid drugs among seniors include the commonly abused OxyContin, Percocet, Vicodin, fentanyl and generic equivalents. The study’s lead author noted concerns about the high rates of use as well as the potential for abuse.

Among seniors, the health risks of all medications are increased, because the body takes longer to break down and get rid of the drug than it does in a younger person.

As a result, the drug stays in an older person’s system longer, where it can cause even greater damage. Seniors are also likely to be taking multiple medications, which raises the risk of drug interactions.

Researchers Surprised by Opioid Scripts for Low-Risk Surgical Procedures

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Opioid-naive adults who underwent at least one of four low-risk surgical procedures—carpal tunnel release, laparoscopic cholecystectomy, inguinal hernia repair and knee arthroscopy—in the years 2004, 2008 and 2012 were prescribed over time an increasing mean opioid morphine equivalent for postoperative pain. The adjusted increase was highest for knee arthroscopy (18%), according to a JAMA research letter (2016 Mar 15. doi: 10.1001/jama.2016.0130. [Epub ahead of print]).

The study authors evaluated a cohort of 155,297 patients from the Clinformatics Data Mart Database. Within seven days after surgery, 80% of patients filled a prescription for an opioid, with 86.4% of prescriptions for either hydrocodone-acetaminophen or oxycodone-acetaminophen.

“Anesthesiologists, surgeons and intensivists spend a lot of time thinking about how best to care for surgical patients while in the hospital,” said lead author Hannah Wunsch, MD, a staff physician in the Department of Critical Care Medicine at Sunnybrook Hospital, in Toronto.

“But more and more we recognize that what we do in the hospital is only part of the story and that many of the problems faced by patients occur after hospital discharge. There is a paucity of data on prescribing practices for patients after surgery.”

The authors were surprised by the amount of opioids prescribed per day for procedures that are considered relatively minor and, therefore, “are unlikely to be associated with a lot of postoperative pain for most people,” Dr. Wunsch said.

The researchers hope that their study, along with new guidelines and other research, will help clinicians recognize the need to evaluate their own prescribing practices.

“Individual prescribers may want to assess whether their prescribing habits have changed and why,” Dr. Wunsch said. “The increase in opioids prescribed may be due to a perception that pain was being undertreated in many patients, or it is an attempt to try to minimize the number of patients who need to be reassessed after discharge.”

Joseph V. Pergolizzi Jr., MD, adjunct assistant professor of medicine at Johns Hopkins School of Medicine, in Baltimore, said the study underscores the ongoing concern of excessive opioid prescribing in a postoperative pain setting.

However, he noted that pain is very individualized, so some patients may require more pain relief than others. In addition, because these patients are no longer under the direct supervision of a physician once discharged from the hospital, it is important that they “have adequate analgesic coverage, thus potentially being prescribed more than they use,” Dr. Pergolizzi said.

Because there are data lacking for a pain trajectory, “we do not know exactly what is going to happen for every person,” Dr. Pergolizzi said. “By not knowing individual pain phenotypes, physicians with the best intentions may overprescribe.” He also said there needs to be a balance between access to these medications for patients who need them and appropriate opioid prescribing, “so that excess amounts of opioids are not prescribed that could potentially find their way out into the general public.”

“There is clearly increasing awareness of the need to be judicious in prescribing opioids,” said Dr. Wunsch. “Care around surgery represents a unique opportunity to focus on ensuring adequate, but not excessive, acute pain treatment. However, the need for large quantities of opioids as the mainstay of routine postoperative care for many patients needs to be reassessed.”

Pharma and Feds Hide Opioid Report

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Increasing numbers of middle-aged Americans are becoming hooked on painkillers, often after using the drugs for back pain. Seeking ever-stronger highs, more potent drugs are now reaching the black market.

opioid report

Story at-a-glance

  • In 2012, Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) began an investigation into financial ties between opioid drug makers and the medical organizations setting guidelines on opioid use
  • Senate staffers spent a year working on the investigation and subsequent report, but its results have not been made public
  • In 2015, public health advocates asked that the findings of the opioid investigation be released, noting that many of those targeted by the report continue to “promote aggressive opioid use and continue to block federal and state interventions that could reduce overprescribing”

There’s W-18, a synthetic opioid that’s said to be 100 times more potent than the opioid pain reliever fentanyl and 10,000 times stronger than morphine. Fentanyl is also being picked up by drug traffickers, who are selling it mixed with (or instead of) heroin.

It’s cheaper to make and far more potent than heroin, making it extremely easy to overdose. In New Orleans, deaths caused by Fentanyl are now higher than the murder rate.1

Meanwhile, more than 28,000 Americans died from opioid overdoses in 2014 — more deaths than any other year on record according to data from the U.S. Centers for Disease Control and Prevention (CDC).

The number includes deaths from both heroin and prescription opioid pain relievers, but the latter accounted for at least half.2,3 The United Nations World Drug Report 2016 also revealed a three-fold increase in U.S. heroin users from 2003, reaching about 1 million in 2014. That’s the most reported in 20 years.

The CDC states that addiction to prescription opioid painkillers is the strongest risk factor for heroin addiction, and among heroin users, 45 percent are also addicted to opioid painkillers.4

Clearly, Americans’ excessive use of opioid painkillers has created a nation of drug addicts, which leaves the burning question: how did this excessive opioid use begin?

Sealed Opioid Report May Hold Clues to the Opioid Overdose Epidemic

In 2012, as opioid overdoses continued to rise, two senators — Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) — began an investigation into financial ties between the drugs’ makers and the medical organizations setting guidelines on opioid use.

The targets of the investigation were Purdue Pharma (maker of Oxycontin), Endo International plc (Percocet) and Johnson & Johnson (Duragesic) along with five organizations, including the Center for Practical Bioethics and the American Pain Foundation (APF).

Senate staffers spent a year working on the investigation and subsequent report, but its results have not been made public (the report is sealed in the Senate Committee on Finance’s office).5

Financial Ties Between Drug Makers, Nonprofits and Policy Makers

There are many reasons to question the relationships between opioid makers and some leading non-profits, as well as their influence on the now out-of-control opioid epidemic. STAT reported some of the most concerning examples in an op-ed article:6

  • The APF, billed as the largest U.S. organization for pain patients, was at one point receiving 90 percent of its funding from pharmaceutical and medical device companies (the foundation shut down days after the investigation began)
  • The Center for Practical Bioethics, which is a supposedly independent nonprofit that helps policymakers and corporate leaders make health care decisions, received ample funding from Purdue Pharma, including seed money to create a $1.5-million chair in pain management

Myra Christopher, who co-founded the Center for Practical Bioethics and holds the chair in pain management, has authored studies in support of opioid use. STAT reported:7

“In 2008, Christopher coauthored a study to calm physicians’ fears that they might be criminally prosecuted or disciplined for inappropriately prescribing opioids.8

In 2011, as money from pharmaceutical companies continued to pour into the center, she wrote a commentary titled ‘It’s Time for Bioethics to See Chronic Pain as an Ethical Issue’ for the American Journal of Bioethics,9 which was then housed at the Center for Practical Bioethics.

The commentary failed to disclose that the center had received funding from the pharmaceutical industry and was one of many articles promoting opioid use the journal published.”

Due to changes in position, it’s now Senator Orrin Hatch (R-Utah), current chair of the Senate Committee on Finance, and Senator Ron Wyden (D-Ore.), who stand to get the opioid report released.

In 2015, public health advocates asked the senators that the findings of the opioid prescribing investigation be released, noting that many of those targeted by the report continue to “promote aggressive opioid use and continue to block federal and state interventions that could reduce overprescribing.”10 Still, the report remains sealed.

New Haven, Connecticut, Declares Public Health Emergency Due to Overdoses

In late June, New Haven, Connecticut — a city known for its New England charm and Yale University — declared a public health emergency after 16 people overdosed on tainted heroin or cocaine in a one-week period.11

Police were investigating whether fentanyl was involved. The surge in overdoses highlights the fact that drug overdoses have reached virtually the entire U.S. In Connecticut alone, more than 200 people had already died from accidental drug overdoses.

Unfortunately, stats like these are not unique. In Utah, 24 people die each month from prescription drug overdoses, and such deaths have outpaced deaths due to firearms, falls and motor vehicle crashes. In Utah, the majority of prescription drug overdoses are due to oxycodone.12

Connecticut Senator Richard Blumenthal told The New York Times, “an increase in ‘treatment services, law enforcement support, opioid overprescription prevention and other steps’ was ‘urgent and critical,’” and this sentiment applies not only to his home state but all of the U.S.13

Overdose Deaths Are Overwhelming Coroner Offices

In Connecticut, the chief medical examiner has considered renting a refrigerated truck to store bodies because the storage space at the medical examiner’s office is often maxed out.

The space shortage is attributed to rising drug overdose deaths, including opioid overdoses, which are pushing many U.S. medical examiner and coroner offices to their limits.

In areas like Cincinnati, Ohio, forensic pathologists responsible for conducting autopsies on many such victims may conduct more than 325 autopsies this year alone. The National Association of Medical Examiners’ (NAME) accrediting program puts the limit at 325 a year, and offices that conduct more risk losing accreditation.

Some coroner’s offices are also facing backlogs of DNA testing for drug investigations, again in large part due to overdose deaths.

Dr. David Fowler, Maryland’s chief medical examiner and president of the NAME, again highlighted the fact that this problem isn’t confined to one area; it stretches across the U.S. He told STAT:14

“There are many, many parts of the country that have substantial problems … I think the drug overdoses have substantially increased the problems.”

Painkiller Deaths Drop in Medical Marijuana States

If you’re in severe pain, there are times when opioid drugs have a place, and they can be of great benefit when used cautiously and correctly. It’s quite clear however, that prescription opioid painkillers are being overprescribed and can easily lead you into addiction and other, more illicit, drug use.

If you’re in severe pain, you need a knowledgeable practitioner who can help you attack the pain from multiple angles, giving you both relief and healing. One option that is receiving increasing attention in the U.S. is medical marijuana.

It’s the cannabidiol (CBD) in marijuana that has medicinal properties. CBD is an excellent painkiller and has been used successfully to treat a variety of pain disorders.

In states where medical marijuana is legal, overdose deaths from opioids like morphine, oxycodone and heroin decreased by an average of 20 percent after one year, 25 percent after two years and up to 33 percent by years five and six.15 For those with severe chronic pain, medical marijuana can be life changing, allowing for a far safer form of treatment than opioids.

There is a wealth of research linking marijuana with pain relief. In one study, just three puffs of marijuana a day for five days helped those with chronic nerve pain to relieve pain and sleep better.16 I do, however, still recommend working with a health care practitioner who can guide you on the most effective dosage and form of use (marijuana may be inhaled, smoked, vaporized, taken orally or even applied topically in oil form).

Non-Drug Solutions for Pain Relief

Not everyone who takes a prescription opioid will wind up an addict, but the risk is real. This is why I strongly recommend exhausting other options before you resort to an opioid pain reliever. The health risks associated with these drugs are great, and addiction and overdose happen far more often than you might think.

Many people find themselves addicted to painkillers before they even realize what’s happened, often after taking the drugs to recover from surgery or treat chronic back, or other pain. The drugs work by binding to receptors in your brain to decrease the perception of pain. But they also create a temporary feeling of euphoria, followed by dysphoria, which can easily lead to physical dependence and addiction.

This may drive some people to take larger doses in order to regain the euphoric effect or escape the unhappiness caused by withdrawal. Others find they need to continue taking the drugs not only to reduce withdrawal symptoms but also to simply feelnormal. Large doses of the painkillers can cause sedation and slowed breathing to the point that your breathing stops altogether, resulting in death.

If you have chronic pain of any kind, please understand that there are many safe and effective alternatives to prescription and even over-the-counter painkillers. The pain remedies that follow are natural, providing excellent pain relief without any of the health hazards that pain medications often carry.

•Astaxanthin: one of the most effective oil-soluble antioxidants known, astaxanthin has very potent anti-inflammatory properties. Higher doses are typically required and one may need 8 milligrams or more per day to achieve this benefit.

•Ginger: this herb is anti-inflammatory and offers pain relief and stomach-settling properties. Fresh ginger works well steeped in boiling water as a tea or grated into vegetable juice.

•Curcumin: curcumin is the primary therapeutic compound identified in the spice turmeric. In a study of osteoarthritis patients, those who added only 200 milligrams of curcumin a day to their treatment plan had reduced pain and increased mobility. In fact, curcumin has been shown in over 50 clinical studies to have potent anti-inflammatory activity, as well as demonstrating the ability in four studies to reduce Tylenol-associated adverse health effects.

•Boswellia: also known as boswellin or “Indian frankincense,” this herb contains powerful anti-inflammatory properties, which have been prized for thousands of years. This is one of my personal favorites, as I have seen it work well with many rheumatoid arthritis patients.

•Bromelain: this protein-digesting enzyme found in pineapples is a natural anti-inflammatory. It can be taken in supplement form, but eating fresh pineapple may also be helpful. Keep in mind that most of the bromelain is found within the core of the pineapple, so consider leaving a little of the pulpy core intact when you consume the fruit.

•Cetyl Myristoleate (CMO): this oil, found in fish and dairy butter, acts as a “joint lubricant” and an anti-inflammatory. I have used a topical preparation for myself to relieve ganglion cysts and a mild annoying carpal tunnel syndrome that pops up when I type too much on non-ergonomic keyboards.

•Evening Primrose, Black Currant and Borage Oils: these contain the fatty acid gamma-linolenic acid (GLA), which is useful for treating arthritic pain.

•Cayenne Cream: also called capsaicin cream, this spice comes from dried hot peppers. It alleviates pain by depleting the body’s supply of substance P, a chemical component of nerve cells that transmit pain signals to your brain.

Dietary Changes and Additional Pain Relief Options

When physicians don’t know how to effectively treat chronic pain, they resort to the only treatment they know: prescription drugs, which will do nothing to solve the underlying reasons why you’re in pain. Toward that end, if you suffer from chronic pain, there’s a good chance you need to tweak your diet as follows:

  1. Start taking a high-quality, animal-based omega-3 fat like krill oil. Omega-3 fats are precursors to mediators of inflammation called prostaglandins. (In fact, that is how anti-inflammatory painkillers work, they positively influence prostaglandins.) The omega-3 fats EPA and DHA contained in krill oil have been found in many animal and clinical studies to have anti-inflammatory properties, which are beneficial for pain relief.
  2. Reduce your intake of most processed foods as not only do they contain sugar and additives, but also most are loaded with omega-6 fats that upset your delicate omega-3 to omega-6 ratio. This, in turn, will contribute to inflammation, a key factor in most pain.
  3. Eliminate or radically reduce most grains and sugars (especially fructose) from your diet. Avoiding grains and sugars will lower your insulin and leptin levels. Elevated insulin and leptin levels are one of the most profound stimulators of inflammatory prostaglandin production. That is why eliminating sugar and grains is so important to controlling your pain.
  4. Optimize your production of vitamin D by getting regular, appropriate sun exposure, which will work through a variety of different mechanisms to reduce your pain. This satisfies your body’s appetite for regular sun exposure.

Finally, the natural pain relief methods that follow are useful for ongoing and lasting pain relief and management:

  • Chiropractic adjustments: according to a study published in the Annals of Internal Medicine and funded by the National Institutes of Health (NIH), patients with neck pain who used a chiropractor and/or exercise were more than twice as likely to be pain-free in 12 weeks compared to those who took medication.17
  • Massage: massage releases endorphins, which help induce relaxation, relieve pain and reduce levels of stress chemicals such as cortisol and noradrenaline.
  • Acupuncture: researchers concluded that acupuncture has a definite effect in reducing chronic pain such as back pain and headaches — more so than standard pain treatment.

Opioid Linked to Low Blood Sugar

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Tramadol was associated with an increased risk of hospitalization for hypoglycemia.

  • Medpage Today

The mild opioid tramadol was associated with an increased risk of hospitalization for hypoglycemia, researchers reported.

In a case-control study, the use of tramadol was associated with a 52% higher risk of hospitalization for hypoglycemia compared with codeine, Samy Suissa, PhD, of McGill University in Montreal, and colleagues reported online in JAMA Internal Medicine.

Risk was highest within the first 30 days of use, they reported — nearly three times as high as that seen with codeine.

Tramadol is seen as a lower-risk alternative to other opioids and its prescriptions have increased in recent years. In August, the opioid became a schedule IV controlled substance.

Suissa and colleagues wrote that three recent case reports have described tramadol-induced hypoglycemia, which included patients with and without diabetes who used the drug at recommended doses.

It’s biologically plausible that tramadol may induce hypoglycemia; it activates the mu-opioid receptor and inhibits central serotonin and norepinephrine reuptake. Serotonin pathways are known to have complex effects on peripheral glucose regulation, the researchers wrote, and antidepressants that work via either serotonin or norepinephrine reuptake inhibition both have been tied to hypoglycemia risk.

They conducted a nested case-control analysis within the U.K. Clinical Practice Research Datalink and the Hospital Episodes Statistics database of 334,034 patients newly treated with tramadol or codeine for pain between 1998 and 2012.

Among these, 1,105 were hospitalized for hypoglycemia during follow-up, and were subsequently matched with 11,019 controls.

Overall, tramadol use was associated with an increased risk of hospitalization for hypoglycemia compared with codeine use (odds ratio 1.52, 95% CI 1.09 to 2.10).

That risk was particularly elevated in the first 30 days of use, they reported (OR 2.61, 95% CI 1.61 to 4.23).

Suissa and colleagues noted that the 2-day increased risk of hospitalization was confirmed in an propensity score-adjusted model (HR 3.6, 95% CI 1.56 to 8.34) and in cross-over analyses (OR 3.80, 95% CI 2.64 to 5.47).

In an accompanying commentary, Lewis Nelson, MD, of New York University Medical Center in New York City, and David Juurlink, MD, PhD, of Sunnybrook Health Sciences Center in Toronto, noted that hypoglycemia was uncommon in the study, with only eight events in more than 26,000 person-months of tramadol therapy.

It’s also unclear why hypoglycemia is less common in patients taking other mu-opioid agonists such as morphine, oxycodone, and hydrocodone, they noted.

Still, since hypoglycemia “can be life threatening, clinicians should remain vigilant for this potential complication of tramadol use, in patients taking the drug as directed, as well as those who abuse it,” they wrote. “Whether tramadol therapy should be particularly avoided in patients receiving hypoglycemic drugs is unclear, but given the drug’s limited benefit and unpredictable pharmacological properties, it should be handled at least as carefully in these patients as in others.”

FDA Okays First Single-Entity Extended-Release Hydrocodone.

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The US Food and Drug Administration (FDA) has approved the first single-entity extended-release formulation of hydrocodone bitartrate (Zohydro ER, Zogenix Inc) for the management of pain severe enough to require daily around-the-clock long-term treatment and for which alternative options are inadequate.

“Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product,” a statement from FDA released today notes.

“Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids.”

This formulation belongs to the class of extended-release/long-acting (ER/LA) opioids, the statement notes. “Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the FDA release said.

It is not approved for as-needed pain relief.

In addition, the labeling approved for this drug conforms to updated labeling requirements for all ER/LA opioids announced by the FDA on September 10 and reported at that time by Medscape Medical News, the first opioid to be labeled in this way, the statement notes.

“The new class of labeling and stronger warnings will more clearly describe the risks and safety concerns associated with ER/LA opioid analgesics, along with the appropriate use of these medications,” the FDA said. “These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices.”

Schedule II drugs can be dispensed only by prescription, and no refills are allowed. Stringent record-keeping, reporting, and physical security requirements are also in place for these substances.

The FDA will require postmarketing studies of this agent to assess the “known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long-term use beyond 12 weeks,” the FDA release said. “These studies will also be required for other ER/LA opioid analgesics.”

Safety of this new formulation of hydrocodone is based on clinical studies that have included more than 1100 patients with chronic pain. Efficacy is based on a clinical study that enrolled more than 500 patients with chronic low back pain and showed a significant improvement in chronic pain vs placebo.

It will also be part of the ER/LA Opioids Analgesics risk evaluation and mitigation strategy (REMS) approved in 2012. The REMS requires companies to make educational programs on how to safety prescribe these agents to healthcare professionals and provide medication guides and patient counseling documents with information on safe use, storage, and disposal of ER/LA opioids.

The most common adverse effects of this single-entity hydrocodone are constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, and pruritus.

In December 2012, FDA’s Anesthetic and Analgesic Drug Advisory Committee of independent experts voted 11 to 2, with 1 abstention, to recommended against approval of this agent for the treatment of moderate to severe chronic pain.

Most panel members voted that the drug had met regulatory requirements for safety and efficacy, as indicated by their responses to questions on efficacy and safety. However, for the last question voted on — “Based on the data presented and discussed today, do the efficacy, safety and risk-benefit profile of Zohydro ER support the approval of this application?” — most had negative responses.

The main concern of those voting against approval was that the potential for abuse of these agents; because the product does not include acetaminophen, they feared the potential for abuse might be even greater.

FDA Okays First Single-Entity Extended-Release Hydrocodone.

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The US Food and Drug Administration (FDA) has approved the first single-entity extended-release formulation of hydrocodone bitartrate (Zohydro ER, Zogenix Inc) for the management of pain severe enough to require daily around-the-clock long-term treatment and for which alternative options are inadequate.

“Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product,” a statement from FDA released today notes.

“Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids.”

This formulation belongs to the class of extended-release/long-acting (ER/LA) opioids, the statement notes. “Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the FDA release said.

It is not approved for as-needed pain relief.

In addition, the labeling approved for this drug conforms to updated labeling requirements for all ER/LA opioids announced by the FDA on September 10 and reported at that time by Medscape Medical News, the first opioid to be labeled in this way, the statement notes.

“The new class of labeling and stronger warnings will more clearly describe the risks and safety concerns associated with ER/LA opioid analgesics, along with the appropriate use of these medications,” the FDA said. “These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices.”

Schedule II drugs can be dispensed only by prescription, and no refills are allowed. Stringent record-keeping, reporting, and physical security requirements are also in place for these substances.

The FDA will require postmarketing studies of this agent to assess the “known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long-term use beyond 12 weeks,” the FDA release said. “These studies will also be required for other ER/LA opioid analgesics.”

Safety of this new formulation of hydrocodone is based on clinical studies that have included more than 1100 patients with chronic pain. Efficacy is based on a clinical study that enrolled more than 500 patients with chronic low back pain and showed a significant improvement in chronic pain vs placebo.

It will also be part of the ER/LA Opioids Analgesics risk evaluation and mitigation strategy (REMS) approved in 2012. The REMS requires companies to make educational programs on how to safety prescribe these agents to healthcare professionals and provide medication guides and patient counseling documents with information on safe use, storage, and disposal of ER/LA opioids.

The most common adverse effects of this single-entity hydrocodone are constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, and pruritus.

In December 2012, FDA’s Anesthetic and Analgesic Drug Advisory Committee of independent experts voted 11 to 2, with 1 abstention, to recommended against approval of this agent for the treatment of moderate to severe chronic pain.

Most panel members voted that the drug had met regulatory requirements for safety and efficacy, as indicated by their responses to questions on efficacy and safety. However, for the last question voted on — “Based on the data presented and discussed today, do the efficacy, safety and risk-benefit profile of Zohydro ER support the approval of this application?” — most had negative responses.

The main concern of those voting against approval was that the potential for abuse of these agents; because the product does not include acetaminophen, they feared the potential for abuse might be even greater.

Source: Medscape.com