AANA developed policies and procedures that align with best available evidence for treating patients taking GLP-1 receptor agonists, which increase insulin synthesis and secretion, suppress glucagon secretion, reduce food intake through appetite suppression, slow gastric emptying, and promote beta-cell proliferation.

Considerations related to preoperative use of GLP-1 receptor agonists include withholding medication on the day of surgery/procedure in the case of a daily dose or the week before surgery in the case of a weekly dose. At this point, there are no changes to fasting guidelines. However, improvements in outcomes have been reported with changes such as a longer fasting period or clear-liquid diet for one to three days before surgery. Gastric point-of-care ultrasound (POCUS) should be considered to assess gastric contents and aspiration risks; the gastric antrum should be visualized when performing POCUS. Where gastric contents are present, a volumetric assessment should be performed to stratify aspiration risks. GLP-1 receptor agonists should be restarted after the procedure at the next scheduled dose.

“Open communication between patients and the surgical team is important with regard to recommendations for withholding GLP-1 agonist medications prior to surgery,” Micah Walden, D.N.P., a member of the AANA Practice Committee, said in a statement. “As providers, we take that information into account to perform an individualized, case-by-case assessment and create a care plan that will keep the patient safe and comfortable before, during, and after the procedure.”

More Information

The Food and Drug Administration (FDA) has approved the Proclaim XR spinal cord stimulation (SCS) system for the treatment of painful diabetic peripheral neuropathy.

The Proclaim XR SCS system consists of an implantable pulse generator that delivers electrical pulses through leads to nerves along the spinal cord.  It was originally approved in 2019 for the treatment of chronic pain.

Clinical studies have shown that SCS treatment in patients with painful diabetic peripheral neuropathy (PDPN) can lead to significant reduction in pain and improved quality of life. When compared with conventional medical treatment alone, the addition of SCS reduced pain more effectively in patients with PDPN in the lower limbs.

Prior to implanting the SCS, a stimulation trial should be performed on a patient to confirm satisfactory pain relief. Patients who successfully complete the trial and undergo implantation of the Proclaim XR SCS device can then control their therapy using an Apple device. The system also pairs with Abbott’s NeuroSphere Virtual Clinic, allowing individuals to communicate with a clinician via a secure in-app video chat and receive remote programming adjustments.

Commenting on the expanded approval, Pedro Malha, vice president, neuromodulation, Abbott, said: “This new indication for Proclaim XR will drive meaningful change in the treatment of pain associated with diabetic peripheral neuropathy and will be an important tool for physicians and patients in managing this debilitating condition.”

Reference

FDA approves Abbott’s spinal cord stimulation for people living with painful diabetic peripheral neuropathy. News release. January 26, 2023. https://www.prnewswire.com/news-releases/fda-approves-abbotts-spinal-cord-stimulation-for-people-living-with-painful-diabetic-peripheral-neuropathy-301731127.html

The Food and Drug Administration (FDA) has expanded the approval of Abbott’s spinal cord stimulation (SCS) devices for the treatment of chronic back pain in people who have not had or are not eligible to receive back surgery. 

The new indication applies to Abbott’s Proclaim SCS products and the Eterna SCS platform. These devices use proprietary BurstDR stimulation technology to deliver pulses of mild electrical energy to alter pain signals traveling from the spinal cord to the brain.

The expanded approval was supported by data from the DISTINCT study (ClinicalTrials.gov Identifier: NCT04479787), which evaluated the efficacy of the BurstDR SCS therapy in adults with chronic back pain (average of 12.8 years of pain) who had not had or were ineligible for surgery. Compared with conventional medical management (eg, physical therapy, medications, injections, acupuncture, massage therapy), patients who received SCS therapy achieved significant back pain reduction at 6 months that was sustained at the 12-month follow-up.

Abbott’s SCS systems are also indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome or diabetic peripheral neuropathy of the lower extremities.

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.”

Abstract/Full Text

Lasmiditan, at higher doses, was found to be more effective than rimegepant and ubrogepant for treating acute migraine attacks, though it was linked to higher odds of adverse events, according to a study published in Cephalalgia.

To investigate the efficacy of newer migraine agents, the researchers conducted a random-effects network meta-analysis that included 7 studies involving nearly 13,000 patients. The trials included were phase 3 studies that examined lasmiditan, a serotonin (5-HT) 1F receptor agonist, and rimegepant and ubrogepant, both calcitonin gene-related peptide receptor antagonists, as acute treatments for migraine.

Findings showed that all 3 medications were superior to placebo on the coprimary endpoints of 2-hour pain freedom and freedom from the most bothersome migraine symptom (MBS) associated with migraine attack. Treatment with higher dose lasmiditan (100mg and 200mg) was found to be more effective than rimegepant (75mg) and ubrogepant (50mg or 100mg) with respect to 2-hour pain freedom, while freedom from MBS was achieved equally by all 3 interventions.

Compared with rimegepant and ubrogepant, lasmiditan was associated with greater odds of treatment-emergent adverse events including dizziness, nausea, and somnolence. Of the 3 medications, ubrogepant 50mg was ranked best for tolerability.

“Rimegepant 75mg and ubrogepant 50 and 100mg present good efficacy and a favorable tolerability profile, albeit lower odds of achieving complete pain freedom,” the authors concluded. They noted that the findings should be interpreted cautiously due to the lack of head-to-head comparisons. 

Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Puledda F, Younis A, Tassorelli C, et al. Efficacy, safety and indirect comparisons of lasmiditan, rimegepant, and ubrogepant for the acute treatment of migraine: A systematic review and network meta-analysis of the literature. Published online February 14, 2023. Cephalalgia. doi.org/10.1177/03331024231151419

Funded by a Food and Drug Administration-provided grant, the new clinical practice guideline for adults and adolescents was developed by the American Dental Association Science & Research Institute, the University of Pittsburgh School of Dental Medicine and the Center for Integrative Global Oral Health at the University of Pennsylvania School of Dental Medicine. This is the second guideline the ADA created for managing acute dental pain; recommendations for pediatric patients were published in 2023.

According to the guideline, following surgical tooth extraction, a nonopioid analgesic such as naproxen 440mg or ibuprofen 400mg either alone or in combination with acetaminophen 500mg should be used as first-line treatment for short-term dental pain. In rare cases when pain control is not attained with the use of an NSAID and acetaminophen, an opioid analgesic (1 tablet combination of acetaminophen 325mg plus hydrocodone 5-7.5mg or oxycodone 5mg) may be added at the lowest effective dose and for the shortest duration possible (eg, max of 3 days). In cases where an NSAID is contraindicated, the panel recommends acetaminophen at its full therapeutic dose (1000mg) or 1 tablet of acetaminophen 325 plus an acetaminophen 325mg/opioid (hydrocodone 5-7.5mg or oxycodone 5mg) combination. 

For simple tooth extraction, the panel recommends against the use of opioid analgesics, favoring only the use of NSAIDs (naproxen 440mg, ibuprofen 400mg) alone or in combination with acetaminophen 500mg. If NSAIDs are contraindicated, the full therapeutic dose of acetaminophen (1000mg) should be used. 

Additional good practice statements outlined in the guideline include:

• Reviewing patient records thoroughly prior to prescribing to avoid potential drug interactions or the possibility of overdose in patients who have reported prior illicit or recreational drug use.
• Writing prescriptions for the minimum effective dose and for the shortest duration possible; routine use of “just-in-case” prescribing of opioids should be avoided.
• Counseling patients on appropriate storage and  disposal of opioids.
• Reviewing the state’s prescription drug monitoring program to determine if the patient is already being prescribed a controlled substance.
• Prioritizing the use of nonopioid analgesics for patients receiving opioids to manage chronic pain.

“It’s important to take special consideration when prescribing any type of pain reliever, and now, dentists have a set of evidence-based recommendations to determine the best care for their patients,” said Dr Paul Moore, DMD, PhD, MPH, the guideline’s senior author and panel chair and professor emeritus at the University of Pittsburgh’s School of Dental Medicine. “Patients are encouraged to discuss pain management expectations and strategies with their dentist so they can feel confident that they are receiving the safest, most effective treatment for their symptoms.”

The full guideline is available here.

Anlan Cao, MBBS, from Yale University in New Haven, Connecticut, and colleagues evaluated the effect of a 6-month aerobic exercise intervention on CIPN among women treated for ovarian cancer. The analysis included 134 participants in the Women’s Activity and Lifestyle Study in Connecticut (65 controls).

The researchers found that at 6 months, the self-reported CIPN score was 1.3 points lower in the exercise intervention arm (95% CI, −2.3 to −0.2) vs an increase of 0.4 points in the attention control arm (95% CI, −0.8 to 1.5). The between-group difference was −1.6 points (95% CI, −3.1 to −0.2). Among participants with CIPN symptoms at baseline, the point estimate was larger (−2.0; 95% CI, −3.6 to −0.5).

“While replication of the findings in other studies is warranted, incorporating referrals to exercise programs into standard oncology care could reduce CIPN symptoms and increase quality of life in patients with ovarian cancer,” the authors write.

Abstract/Full Text

HealthDay News — Following a 4-day raid, Mexico has closed 23 pharmacies in Caribbean resorts of Cancun, Playa del Carmen, and Tulum for irregular pill sales.

Last spring, the US warned of dangerous pill sales to foreigners and tourists where counterfeit drugs contained fentanyl, heroin, and methamphetamine. Mexican investigators went to 55 drug stores, finding irregular sales at 23 of them, according to the Mexican Navy Department.

In a study from researchers at the University of California in Los Angeles, the scientists said they visited 40 pharmacies in four Northern Mexico cities, finding that 68% sold oxycodone, Xanax, or Adderall. About 27% of those pharmacies were selling fake pills, according to the report, which said “brick and mortar pharmacies in Northern Mexican tourist towns are selling counterfeit pills containing fentanyl, heroin, and methamphetamine. These pills are sold mainly to US tourists, and are often passed off as controlled substances such as oxycodone, Percocet and Adderall.”

In the raids, the Navy said it found outdated medications and those with no supplier record, the Associated Press reported. Also found were blank and unsigned prescription forms. The Navy did not confirm finding fentanyl-laced pills, but it did say that the medications would be tested for the presence of fentanyl.

Fentanyl is responsible for about 70,000 deaths each year in the US, the AP reported, noting that Mexican cartels produce it from chemicals smuggled in from China.

“These counterfeit pills represent a serious overdose risk to buyers who think they are getting a known quantity of a weaker drug,” researcher Chelsea Shover, PhD, an assistant professor-in-residence of medicine at the David Geffen School of Medicine at UCLA, told the AP in February.

Associated Press Article

Akorn has initiated a voluntary recall of various within-expiry drug products as the company has shut down operations and is unable to assure the quality of the products.

The recalled products were distributed nationwide to wholesalers, retailers, manufacturers, medical facilities, and repackagers and via the Internet to consumers. The discontinuation of the Company’s Quality program means that it is unable to support or guarantee that the medications will meet all intended specifications through the labeled shelf life of the product.

All NDCs and Lots of the following Akorn products have been recalled:

• Acetaminophen & Codeine Phosphate Oral Solution 120mg & 12mg/5mL
• Acetic Acid Otic Solution
• Acyclovir Oral Suspension, 200mg/5mL
• Albuterol Sulfate Syrup, 2mg (base)
• Amantadine HCl Syrup, USP 50mg per 5mL
• Apraclonidine Ophthalmic Solution 0.5%
• Artificial Tears
• Atropine Sulfate Ophthalmic Solution
• Azelastine Hydrochloride Nasal Spray, 0.1%
• Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, 3.5g
• Calcipotriene Scalp Solution, 0.005%
• Calcitriol Injection 1mcg and 2mcg
• Cetrorelix Acetate for Injection, 0.25mg/vial, Single-Dose Vial
• Ciclopirox Topical Solution 8%
• Cimetidine HCl Oral Solution
• Clobetasol Propionate Cream 0.05%
• Clobetasol Propionate Ointment, 0.05%
• Clobetasol Propionate Shampoo, 0.05%
• Cromolyn Sodium Ophthalmic Solution 4%
• Detomidine Hydrochloride 20mL and 5mL
• Dicyclomine Hydrochloride Injection USP, 20mg/2 mL (10mg/mL)
• Diuril^® (chlorothiazide sodium) Injection
• DOCU LIQUID- docusate sodium liquid
• Ephedrine Injection 50mg/mL
• Fentanyl Citrate Injection
• Ferrous Sulfate Elixir and Iron Supplement
• Fluticasone Propionate Nasal Spray
• Gonak Hypromellose Ophth Sol
• Granisetron HCl Injection 1mg/mL
• Guaifenesin and Codeine Phosphate Liquid
• Hydralazine HCl Injection
• Hydrocortisone and Acetic Acid Otic Solution
• Hydromorphone High Potency Injection USP – Ampule and Vial
• IC-Green Sterile Indocyanine Green Injection USP
• Ketorolac Tromethamine Ophthalmic Solution, 0.5%
• Lactulose Syrup (Oral) and (Oral/Rectal)
• Levetiracetam Injection USP, 500mg/5 mL (100mg/mL) single-dose vial
• Levocarnitine Oral Solution, USP
• Levofloxacin Injection, 25mg/mL
• Levofloxacin Oral Solution
• Levofloxacin Opth Solution
• Lidocaine 2.5% & Prilocaine 2.5% Cream
• Lidocaine Ointment
• Lidocaine HCl Jelly USP, 2%
• Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%
• Lorazepam Injection 2mg/mL vial
• Lorazepam Oral Concentrate, 2mg
• Megestrol Acetate Oral Suspension 40mg/mL
• Midazolam Injection USP 1mg/mL & 5mg/mL – vial
• Moxifloxacin HCl Solution 0.5%  
• Naloxone Injection 0.4mg/mL; 1mL and 10mL Vial
• Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment
• Olopatadine HCl Nasal Spray, 665mcg/spray
• Olopatadine Solution 0.1% and 0.2%   
• Oxcarbazepine Oral Suspension USP, 300mg/5 mL
• Pilocarpine 1, 2, & 4%         
• Prednisolone Sodium Phosphate Oral Solution
• Promethazine HCl & Codeine Phosphate Oral Solution
• Promethazine HCl Oral Solution
• Proparacaine HCl Ophthalmic Solution, 0.5%
• Rifampin Capsules USP, 150mg & 300mg
• Ropivacaine Hydrochloride Injection USP, 0.2% and 5mg/mL
• Sodium Chloride Ophthalmic Ointment
• Sodium Chloride Solution Drops
• Sodium DIURIL
• Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL
• Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL
• Timolol Maleate Ophthalmic Solution 0.5%, 2.5, 5, 10, & 15mL
• Tobramycin Inhalation Solution USP, 300mg/5 mL
• Tobramycin Ophthalmic Solution 0.3%
• Trihexyphenidyl HCl Oral Sol
• Tropicamide Ophthalmic Solution 0.5% and 1%
• Valproic Acid Oral Solution
• Vitamin D Suppl. Drops 50mL
• Xopenex– levalbuterol hydrochloride solution, concentrate

Further distribution or use of these recalled products should be discontinued immediately. To date, the Company has not received any reports of adverse events related to this recall.

Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program. Consumers with questions regarding this recall can contact Akorn at (800) 932-5676.

The Food and Drug Administration (FDA) has approved Amphastar’s New Drug Application (NDA) for naloxone hydrochloride nasal spray 4mg for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression for adult and pediatric patients.

Naloxone hydrochloride nasal spray is an opioid antagonist designed using the Company’s proprietary nasal delivery device. It is a prescription medication intended for immediate administration as emergency therapy in settings where opioids may be present.

The product is supplied as a carton containing 2 unit-dose devices; each device delivers a single spray containing 4mg of naloxone hydrochloride (equivalent to 3.6mg of naloxone). The device is ready to use and does not require priming or testing prior to administration.

Commenting on the FDA nod, Dr Jack Zhang, Amphastar’s President and Chief Executive Officer, said: “The approval of our naloxone hydrochloride nasal spray marks an important step in helping alleviate the opioids crisis as patients can further broaden their access to a critical product.”

References

1. Amphastar Pharmaceuticals receives FDA approval for Naloxone Hydrochloride Nasal Spray 4mg. News release. Amphastar Pharmaceuticals. March 8, 2023. Accessed March 9, 2023. https://ir.amphastar.com/websites/amphastar/English/2110/news-detail.html?airportNewsID=fd568d0c-36f7-43b9-a888-87c8afa3e096.
2. Naloxone Hydrochloride Nasal Spray. Package insert. Amphastar Pharmaceuticals; 2023. Accessed March 9, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s000lbl.pdf.