HealthDay News — An estimated 20.9% of US adults experienced chronic pain during 2021, according to research published in the April 14 issue of the US Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

S. Michaela Rikard, PhD, from the US National Center for Injury Prevention and Control at the CDC in Atlanta, and colleagues examined data from the 2019 to 2021 National Health Interview Survey to provide updated estimates of the prevalence of chronic pain and high-impact chronic pain among adults in the US and within population subgroups.

The researchers found that an estimated 20.9% of US adults experienced chronic pain during 2021, and 6.9% experienced high-impact chronic pain (51.6 and 17.1 million persons, respectively). Populations experiencing a higher prevalence of chronic pain and high-impact chronic pain include non-Hispanic American Indian or Alaska Native adults, adults identifying as bisexual, and adults who are divorced or separated.

“This study provides updated estimates of the prevalence of chronic pain and high-impact chronic pain and highlights disparities in the prevalence of pain among certain populations,” the authors write. “These findings can guide policymakers, clinicians, and researchers in future research examining the underlying reasons for disparities and in the development of tailored interventions and strategies addressing chronic pain in the United States.”

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Arnicare Arthritis Cream is now available over-the-counter (OTC) for the temporary relief of minor joint pain, muscle pain, and stiffness due to arthritis for individuals aged 12 years and older.

The cream is part of Boiron’s Arnicare product line, which also includes oral pellets and tablets, as well as arthritis tablets. Arnicare Arthritis Cream contains Arnica montana and Harpagophytum (devil’s claw). These homeopathic agents are expected to improve muscle pain and stiffness. The fragrance-free formulation does not contain ingredients that may irritate the skin such as camphor and menthol.

Arnicare Arthritis Cream is supplied in a 2.5oz tube and retails for $17.99.

“We are excited to bring Arnicare Arthritis Cream to the market as an affordable and alternative pain relief option for the millions of Americans living with arthritis,” said Ron Gentry, vice president of Marketing, Boiron USA. “Harpagophytum has demonstrated its versatility and utility in the joint supplement space, and our homeopathic medicine now brings this ingredient to the OTC world.”

A recent review of articles published about devil’s claw found the medicinal plant to have both anti-inflammatory and analgesic properties, though the study’s authors note that additional clinical trials in humans would help close the gap on research regarding its efficacy and safety.

Products labeled as homeopathic medicines have not been evaluated by the Food and Drug Administration for safety and effectiveness.

HealthDay News — The incidence of chronic pain is high among US adults compared with other chronic diseases and conditions, including diabetes, depression, and hypertension, according to a study published online May 16 in JAMA Network Open.

Richard L. Nahin, MPH, PhD, from the National Center for Complementary and Integrative Health at the National Institutes of Health in Bethesda, Maryland, and colleagues estimated the rates of chronic pain and high-impact chronic pain (HICP) incidence and persistence in US adults across demographic groups in a cohort study using data from the 2019 to 2020 National Health Interview Survey (NHIS) Longitudinal Cohort. The final analytical sample included 10,415 adult participants in both the 2019 and 2020 NHIS (51.7% female; 54.0% aged 18 to 49 years; 72.6% White).

The researchers found that the incidence rates of chronic pain and HICP in 2020 were 52.4 and 12.0 cases per 1000 person-years (PY), respectively, among adults who were pain-free in 2019. In 2020, the rates of persistent chronic pain and persistent HICP were 462.0 and 361.2 cases per 1000 PY, respectively, among adults with baseline chronic pain.

“The incidence of chronic pain (52.4 cases per 1000 PY) was high compared with other chronic diseases and conditions for which the incidence in the US adult population is known, including diabetes, depression, and hypertension,” the authors write. “This comparison emphasizes the high disease burden of chronic pain in the US adult population and the need for both prevention and early management of pain before it can become chronic.”

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HealthDay News — For patients with acute low back pain, the comparative effectiveness and safety of analgesic medications is unclear, according to a systematic review and meta-analysis published online March 22 in The BMJ.

Michael A. Wewege, from the University of New South Wales in Sydney, and colleagues conducted a systematic review and network meta-analysis to assess the comparative effectiveness and safety of analgesic medicines for acute nonspecific low back pain. Data were reviewed from 98 randomized controlled trials (15,134 participants), which included 69 medicines and combinations.

The researchers observed low or very low confidence in evidence for reduced pain intensity after treatment with tolperisone, aceclofenac plus tizanidine, pregabalin (mean differences, −26.1, −26.1, and −24.7, respectively), and 14 other medicines vs placebo. There was low or very low confidence seen for no difference between the effects of several of these medications. There was moderate to very low confidence noted for increased adverse events with tramadol, acetaminophen plus sustained-release tramadol, baclofen, and acetaminophen plus tramadol compared with placebo (risk ratio, 2.6, 2.4, 2.3, and 2.1, respectively). There was moderate-to-low confidence for these medicines increasing the risk for adverse events compared with other medicines. For secondary outcomes and a secondary analysis of medicine classes, moderate-to-low confidence was also noted.

“Despite nearly 60 years of research involving more than 15,000 patients, high quality evidence to guide clinical decisions on analgesic medicines for acute nonspecific low back pain remains limited,” the authors write.

The Sydney Pharmacy School receives funding from GlaxoSmithKline for a postgraduate scholarship supporting a research student supervised by one of the authors.

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The Food and Drug Administration (FDA) has approved Daxxify^® (daxibotulinumtoxinA- lanm) for the treatment of cervical dystonia in adults.

DaxibotulinumtoxinA-lanm is an acetylcholine release inhibitor and neuromuscular blocking agent. The approval was based on data from a double-blind, placebo-controlled trial (ASPEN-1; ClinicalTrials.gov Identifier: NCT03608397) that included patients with a clinical diagnosis of cervical dystonia with baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score of at least 20, TWSTRS severity score of at least 15, TWSTRS disability score of 3 or greater, and TWSTRS pain score of 1 or greater (N=301). Eighty-four percent of these patients had previously received botulinum toxin as a treatment for cervical dystonia.

Study participants were randomly assigned to receive a single administration of 2.5mL of Daxxify 125 Units (n=125), Daxxify 250 Units (n=130), or placebo (n=46), divided amongst the affected muscles. The primary endpoint was the mean change in the TWSTRS total score from baseline averaged over weeks 4 and 6.

Compared with placebo, the mean change from baseline in the total TWSTRS score was significantly greater in the Daxxify 125U group (least squares mean [LSM] difference from placebo, -8.4 [95% CI, -12.2, -4.6]; P <.0001) and the Daxxify 250U group (LSM difference from placebo, -6.6 [95% CI, -10.4, -2.8]; P =.0007).

Median duration of effect (defined as time from treatment until loss of ≥80% of the peak effect) was reported to be 24 and 20.3 weeks in the Daxxify 125U and Daxxify 250U groups, respectively. Significant improvement with both dosages was also observed in the clinician global impression of change and patient global impression of change scales.

The most common adverse reactions reported were headache, injection site pain, injection site erythema, muscular weakness, and upper respiratory tract infection.

Daxxify is supplied as a lyophilized powder for reconstitution in single-dose 50 Unit and 100 Unit vials. The recommended dose for cervical dystonia ranges from 125 Units to 250 Units. Treatment is administered intramuscularly as a divided dose among affected muscles.

Drug-Induced Photosensitivity

Horizon Therapeutics will no longer be manufacturing Duexis^®, according to the FDA’s Drug Shortages tracker. The update was noted as a business decision and not related to the drug’s safety.

Duexis is a combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the histamine H₂-receptor antagonist famotidine. It is indicated for the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications.

While therapeutic equivalents of Duexis are currently available, Teva Pharmaceuticals has announced that it has discontinued manufacturing its generic version of the drug.

Additional information on NSAID-based therapies for rheumatoid arthritis and osteoarthritis can be found here.

The Companies were flagged for marketing the following products:

• TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9%;
• SeeNext Venture, Ltd.: NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30g) and NumbSkin 10.56% Lidocaine Numbing Cream;
• Tattoo Numbing Cream Co.: Signature Tattoo Numbing Cream and Miracle Numb Spray;
• Sky Bank Media, LLC, doing business as Painless Tattoo Co.: Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray;
• Dermal Source, Inc.: New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1; and
• Indelicare, doing business as INKEEZE: Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label and Ink Eeze B Numb Numbing Foam Soap. 

According to the FDA, some of these OTC analgesic products may contain concentrations of lidocaine that are higher than what is permitted, which may put consumers at risk for serious injury, including irregular heartbeat, seizures, and breathing difficulties.  

The FDA states that consumers should not use OTC pain relief products with more than 4% lidocaine on their skin. Moreover, these products should not be applied heavily over large areas of skin or to irritated or broken skin. Consumers should also not wrap skin treated with these products with plastic wrap or other dressings.

“These products pose unacceptable risks to consumers and should not be on the market,” said Jill Furman, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We are committed to using all available tools to stop the sale of these illegal high-risk products.”

By year’s end, patients who meet a very narrow criteria for medical cannabis use under Georgia’s law will be able to buy low-dose THC products at their local pharmacy.

What that will not mean is joints being sold at pharmacies, said Gary Long, CEO of the medical cannabis production company Botanical Sciences, one of two licensed distributors in Georgia, CNN reported. What it will mean is that pharmacies around the state that want to sell products with THC content of 5% or less can file an application with the Georgia Board of Pharmacy. Products may include oils, tinctures, topicals, capsules, and lozenges.

Long said 130 local pharmacies have agreed to sell his products. A professional association representing independent pharmacies said many of the state’s 400 independent pharmacies have seemed interested in getting the license.

Yet, it is still federally illegal to sell any form of cannabis. “It’s federally illegal for a pharmacist, I’m pretty certain, to dispense cannabis, but it’s also federally illegal to do anything with cannabis,” said Jay Wexler, a professor of law at Boston University School of Law and author of Weed Rules, a book focused on legalization. “In the cannabis space, many things are formally illegal, but the question becomes whether anybody can or is willing to do anything about it,” he told CNN.

Long is hoping to see increased access because Georgia’s medical marijuana law is still more restrictive than most states, CNN reported. Among those restrictions are that doctors can only prescribe the drug for people with 16 particular diseases, including some stages of cancer, posttraumatic stress disorder, and Alzheimer disease.

CNN Article

The Food and Drug Administration (FDA) is advising against the purchase of several dietary supplements that are being promoted for the treatment of joint pain and rheumatoid arthritis as these products contain hidden drug ingredients.

Specifically, the Agency has issued alerts for Fast-Act Rheuma Capsule, New Fast-Act Rheumatism Capsule, and UA-Block. These dietary supplements were sold online on various websites as well as in retail stores.

Laboratory analysis has confirmed the following active ingredients have been identified in these products and are not listed on the label:

• Fast-Act Rheuma Capsule: Prednisone-21-acetate, a corticosteroid, and piroxicam, a nonsteroidal anti-inflammatory drug (NSAID);
• New Fast-Act Rheumatism Capsule: Indomethacin, an NSAID;
• UA-Block: Indomethacin.

Individuals taking these supplements may be at increased risk for serious side effects (eg, cardiovascular events, gastrointestinal damage), especially if they are already using a medication that contains an NSAID, or are on a medication that interacts with the hidden ingredient. Additionally, the use of corticosteroids for a prolonged period of time can lead to adrenal suppression, with abrupt cessation resulting in withdrawal symptoms.

Adverse events related to these products should be reported to the FDA’s MedWatch program.

The table below is a review of notable updates that occurred in May 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

The Motive Knee, a muscle stimulation device for knee pain, has been made available by Motive Health, Inc.

Approved by the Food and Drug Administration (FDA), the Motive Knee is an over-the-counter electrical muscle stimulator that continuously contracts the quadriceps muscles, strengthening them, and relieving knee pain associated with knee arthritis. The device is supplied with reusable therapy pads, a knee wrap, conductive gel, and a charging cable. Each reusable pad lasts for approximately 14 uses.

The device is indicated for use by adults aged 22 years and older. The recommended duration of treatment is 30 minutes per day. Using the MyMotive application, users can personalize therapy levels and monitor their progress. 

A clinical study (ClinicalTrials.gov Identifier: NCT04128618) evaluating the device in 156 patients with knee osteoarthritis showed that home-based neuromuscular electrical stimulation therapy led to clinically meaningful reductions in knee pain at 12 weeks. Improvements in mobility and functionality were also observed.

The Motive Knee device is contraindicated for use in patients who are pregnant, younger than 22 years of age, or in those with an implanted electronic device (eg, cardiac pacemaker, defibrillator). The device should not be placed over fresh surgical stitches, on freshly shaved skin, or across the chest, head, or mouth.

Motive Knee is available without a prescription on Motive Health’s website with prices starting at $399 for a complete therapy system. 

“The direct-to-consumer launch of Motive Health is an exciting time not only for the company but for consumers who can now have access to lasting knee pain relief from home,” added Rob Morocco, President and CEO of Motive Health. “Our technology is a game changer for anyone trying to get back to an active lifestyle that is limited by debilitating knee pain. We are delighted to make Motive Knee accessible to those in need through our new e-commerce platform.”

HealthDay News — For acute nonspecific low back pain or neck pain, opioids do not confer benefits compared with placebo, according to a study published online June 28 in The Lancet.

Caitlin M.P. Jones, PhD, from the University of Sydney, and colleagues recruited adults presenting to one of 157 primary care or emergency department sites within 12 weeks or less of low back or neck pain (or both) of at least moderate severity. Participants were randomly assigned to guideline-recommended care plus an opioid (oxycodone-naloxone, up to 20mg oxycodone per day orally) or guideline-recommended care and an identical placebo for up to six weeks. The primary analysis included 151 participants in the opioid group and 159 in the placebo group.

The researchers found that pain severity for each group was not different at 6 weeks: 2.78 and 2.25 in the opioid and placebo groups, respectively (adjusted mean difference, 0.53; 95% CI, −0.00 to 1.07; P =.051). At least one adverse event was reported by 35 and 30% of participants in the opioid and placebo groups, respectively; more people in the opioid group reported opioid-related adverse events (e.g., constipation in 7.5 vs 3.5%).

“There is no evidence that opioids should be prescribed for people with acute nonspecific low back pain or neck pain,” the authors write.

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