The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy).
The study groups are:
* Control group: standard pain control with opioids
* Experimental group: multimodal non-opioid pain control
Study Outcomes are:
* VAS pain scores (7 days),
* Total opioid usage
* Patient satisfaction
* Adverse events
We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.

Start Date01 May 2025

Sponsor / Collaborator

University of Puerto Rico

NCT06903585

/ Not yet recruitingPhase 2IIT

Non-steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy: A Randomized Controlled Trial

Solid tumors have the tendency to spread to other organs in around 26% of cases, with many cases involving the bone causing severe bone destruction and pain that reduces patients' quality of life. Palliative radiation therapy is used as a standard of care to decrease cancer-related bone pain, as it has been proven to provide pain relief in many patients, either partially or totally, within only a few weeks. However, some patients experience worsening of bone pain especially within the first 10 days after radiation therapy, this is called bone pain flare, and its incidence is estimated to be around 40%. This pain flare tends to further reduce these patients' quality of life considering their main illness, which necessitates its prevention or alleviation.
Non-Steroidal Anti-inflammatory Drugs (NSAIDs) which are a key component of the World Health Organization (WHO) analgesic options used to alleviate cancer pain have not had a good share of published trials in the prevention of bone pain flares.
In this light the investigators aim to conduct a double-blinded, placebo-controlled randomized controlled trial to investigate the effectiveness of NSAIDs, specifically Proxen, in preventing bone pain flares after palliative radiotherapy, and as a secondary endpoint they will compare the quality of life and side effects experienced by patients in either group.

Start Date01 Apr 2025

Sponsor / Collaborator

American University of Beirut Medical Center

NCT06861920

/ RecruitingPhase 4

Targeting Interindividual Variability in NSAID Responses to Mitigate Chronic Pelvic Pain Risk in Dysmenorrhea

The goal of this clinical trial is to learn if NSAIDs (i.e. naproxen sodium) can treat menstrual pain and prevent the development of chronic pelvic pain in menstruating adults with painful periods. The main questions it aims to answer are:
* Can non-menstrual pelvic pain reduction be predicted by menstrual pain response to NSAIDs?
* Will participants with the largest reductions in multi-site sensitivity following NSAID therapy have the largest reductions in non-menstrual pelvic pain?
Researchers will compare naproxen sodium to a placebo (a look-alike substance that contains no drug) to see if naproxen sodium works to treat painful periods.
Participants will:
* Take naproxen sodium or placebo during several days of their menstrual period every month for 1 year.
* Complete computer questionnaires and tests from home every 3 months.
* Complete at-home urine tests to measure hormones every few days for 1-year.
* Use a pin-prick to collect a small spot of blood, and use a pad or tampon to collect a sample of menstrual blood, and bring it to the research site twice over a 1-year period.
* Come to the research site twice over a 1-year period to complete sensory assessments and undergo a blood draw.
The major goal of the study is to develop a multivariable statistical model (see https://grants-nih-gov.libproxy1.nus.edu.sg/grants/guide/rfa-files/RFA-NS-24-021.html ) describing the factors that effectiveness of pain medication and risk for chronic pain

Start Date01 Apr 2025

Sponsor / Collaborator

Endeavor Health

[+2]

100 Clinical Results associated with Naproxen

100 Translational Medicine associated with Naproxen

100 Patents (Medical) associated with Naproxen

16,235

Literatures (Medical) associated with Naproxen

01 Sep 2025·COLLOIDS AND SURFACES B-BIOINTERFACES

Understanding the transport of drugs across biomimetic barriers of various phospholipid compositions using a combined experimental and computational approach

Article

Author: Teleki, Alexandra ; Jacobsen, Ann-Christin ; Tønning, Mikkel Højmark ; Bauer-Brandl, Annette ; Kabedev, Aleksei

Permeapad® is an artificial biomimetic barrier for in vitro permeation experiments, which has an intricate nano- and microstructure consisting of two cellulose hydrate sheets enclosing a layer of phospholipids forming multiple, multilamellar vesicles in contact with the assay medium. Due to this structure, transport across this barrier can be regarded as complex deserving further attention. Until now, only Permeapad® with phosphatidylcholine, the most abundant phospholipid in cell membranes, has been described in literature. However, from biological systems and other artificial barriers, it is known that permeation properties can vary with phospholipid composition. This study presents a combination of experimental and computational techniques to study and explain the transport of molecules across the Permeapad® barrier. For this, we investigated Permeapad® variants with other phospholipid compositions including phosphatidylethanolamine, the second most abundant phospholipid in cell membranes, and phosphatidylglycerol, representing a phospholipid with a negatively charged headgroup by measuring the permeability of three drugs, metoprolol (a weak base), naproxen (a weak acid) and hydrocortisone (a non-ionizable drug). Phospholipid composition only affected the permeability of metoprolol significantly. We used molecular dynamics simulations to understand the underlying mechanisms of the permeability differences extracting several descriptors of membrane properties and predicting permeability. Surprisingly, an almost inverse relationship between experimental and computational permeability was observed. Permeapad®'s highly compartmentalized structure was hypothesized to cause this observation. This study offers a deeper understanding of the functionality of the Permeapad® barrier.

01 Aug 2025·ENVIRONMENTAL RESEARCH

Occurrence and removal of pharmaceuticals in hospital wastewater and the contribution to wastewater treatment plants

Article

Author: Di, Bin ; Zheng, Xiaoyu ; Tao, Wenjia ; Qiao, Hongwei ; Zhang, Yu ; Liu, Peipei

The pervasive presence of drugs in aquatic environments has emerged as a pressing global issue, with hospital wastewater (HWW) recognized as a significant pollution source. This study evaluates the occurrence, removal efficiency, and environmental risks of 21 common pharmaceuticals or their metabolites in HWW. The 21 compounds included opioids, methylxanthines, β-blockers, non-steroidal anti-inflammatory drugs (NSAIDs), antihistamines, β-adrenoceptor agonists, phenylethylamines, benzodiazepines, organic amine compounds, neuraminidase inhibitors, and amide local anesthetics. Additionally, the contribution of HWW discharges to the influent concentrations of downstream wastewater treatment plants (WWTPs) was assessed. In HWW, opioid concentrations varied from 0 ng/L to 7263 ng/L (tramadol) in influent samples and from 0 ng/L to 4163 ng/L (tramadol) in effluent samples. NSAID concentrations in the hospital influents ranged from 0 ng/L to 47,299 ng/L (acetaminophen), while effluent concentrations ranged from 0 ng/L to 58,520 ng/L (acetaminophen). Other compounds ranged from 0 ng/L to 11,956 ng/L (caffeine) in influents and from 0 ng/L to 10,804 ng/L (caffeine) in effluents. Removal efficiencies for various compounds ranged from negative values to 100 %, with significant variability across hospitals and compound types. Opioid removal varied between -49.63 % (pethidine) and 100 %. For NSAIDs, the range was -28.08 % (naproxen) to 100 %. Other compounds exhibited removal efficiencies spanning from -37.90 % (methoxyphenamine) to 100 %. These findings underscore the ineffectiveness of conventional wastewater treatment processes in removing pharmaceutical contaminants. The overall contribution of the HWW effluent to downstream WWTPs drugs loads varied significantly. Opioid contributions ranged from 0 % to 69.46 % (tramadol), while NSAIDs contributions ranged from 0 % to 12.12 % (acetaminophen). Other compounds showed contributions ranging from 0 % to 18.58 % (lidocaine). Environmental risk assessments indicated that four compounds posed high-risk, three presented moderate-risk and fourteen constituted low-risk. This study aims to improve HWW control in China and reduce uncertainties in drug-related early warning systems, thereby supporting broader anti-drug initiatives.

01 Aug 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Utilizing copper-doped graphene quantum dots as a fluorescent sensor for determination of carbamazepine in exhaled breath condensate

Article

Author: Jouyban-Gharamaleki, Vahid ; Rahimpour, Elaheh ; Khoubnasabjafari, Maryam ; Keyvani, Aylar ; Jouyban, Abolghasem ; Soleymani, Jafar

Carbamazepine is a versatile pharmaceutical used mainly for epilepsy and mood stabilization, but like all medications, it requires careful monitoring due to its potential side effects and interactions. In the current work, a fluorescent nanosensor was developed for the carbamazepine determination in the exhaled breath condensate (EBC). The nanosensor consists of graphene quantum dots doped with copper (Cu-doped GQDs). The presence of carbamazepine significantly decreased the fluorescence of Cu-doped GQDs, resulting in a quenching effect within a concentration range of 0.02-2.0 µg/mL, which occurs due to dynamic, rather than static, quenching according to Stern-Volmer plot. The relative standard deviations for intra-day and inter-day analysis of carbamazepine were 1.8 % and 4.8 %, respectively. The validated sensor was effectively employed for carbamazepine analysis in EBC of patients receiving the drug.

News (Medical) associated with Naproxen

12 Mar 2025

·www.prnewswire.com

Psoriatic Arthritis Market Sees Major Shift with Growing Biosimilar Adoption | DelveInsight

The arrival of biosimilars like Celltrion's STEQEYMA and Biocon's YESINTEK is shaking up the psoriatic arthritis market, challenging blockbuster biologics with cost-effective alternatives. As competition intensifies, these biosimilars are reshaping treatment choices and driving a shift in the market landscape. LAS VEGAS, March 12, 2025 /PRNewswire/ -- Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects approximately 112 per 100,000 adults worldwide. It is more prevalent in Europe and North America than in Asia and South America. In patients with psoriasis, the prevalence of psoriatic arthritis can range from 6% to 34% in Western populations. Despite its impact, many individuals with psoriatic arthritis remain undiagnosed or receive inadequate treatment, highlighting the need for increased awareness and access to specialized care. As per DelveInsight analysis, among the 7MM, the United States accounted for the highest number of prevalent cases of psoriatic arthritis in 2023, and these cases are expected to increase by the end of 2034 due to several key factors such as an increase in awareness and diagnosis, as well as the rapid prevalence of PsA. Psoriatic arthritis, occurring in approximately 20% of individuals with psoriasis, is a chronic inflammatory arthritis intricately linked to psoriatic arthritis. This aggressive condition is characterized by potential significant morbidity and compromised quality of life. Treatment approaches for psoriatic arthritis encompass a variety of strategies aimed at managing symptoms, slowing disease progression, and improving the overall quality of life. These approaches typically involve a combination of pharmacological therapies, lifestyle modifications, and, in severe cases, surgical interventions. Psoriatic arthritis treatment is highly individualized based on disease severity, response to therapy, and patient preferences, with multidisciplinary care from rheumatologists, dermatologists, and physical therapists playing a key role. Pharmacological treatment for psoriatic arthritis primarily targets inflammation and pain relief. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, are often the first line of defense, helping to reduce pain and inflammation. Disease-modifying antirheumatic drugs (DMARDs) like methotrexate, sulfasalazine, and leflunomide are commonly prescribed to prevent joint damage and suppress the inflammatory process. For individuals with mild-to-moderate psoriatic arthritis, oral small molecules (OSMs) like OTEZLA (apremilast) offer a convenient, non-injectable option by modulating inflammatory pathways. Biologic agents have revolutionized the treatment landscape for psoriatic arthritis. These medications specifically inhibit key molecules in the inflammatory cascade. TNF inhibitors like HUMIRA (adalimumab), ENBREL (etanercept), and REMICADE (infliximab) are frontline biologics that target tumor necrosis factor, a crucial driver of inflammation. Patients who do not respond to TNF inhibitors may benefit from IL-17 inhibitors like COSENTYX (secukinumab) and TALTZ (ixekizumab) or IL-12/23 inhibitors such as STELARA (ustekinumab). Learn more about the FDA-approved psoriatic arthritis drugs @ Drugs for Psoriatic Arthritis Treatment SKYRIZI (risankizumab), developed by AbbVie, is a humanized IgG1 monoclonal antibody that acts as an interleukin-23 (IL-23) antagonist. It can be used on its own or in conjunction with non-biologic DMARDs. In June 2022, the FDA approved SKYRIZI as the first and only targeted IL-23 inhibitor for adults with active psoriatic arthritis. Another biologic, TREMFYA (guselkumab by Janssen), was approved by the FDA in July 2020 as the first monoclonal antibody that selectively binds to the p19 subunit of IL-23, further expanding treatment options for psoriatic arthritis patients. BIMZELX (bimekizumab), developed by UCB Biopharma, is a humanized monoclonal antibody that targets IL-17A and IL-17F. It received European Commission approval in June 2023 for adults with active psoriatic arthritis and axial spondyloarthritis. On September 23, 2024, the FDA approved BIMZELX for treating adults with active psoriatic arthritis, non-radiographic axial spondyloarthritis (nr-axSpA) with objective inflammation, and active ankylosing spondylitis. In Phase III studies, BIMZELX showed meaningful responses in patients with inadequate TNF inhibitor responses and those new to biologics, indicating its potential as an important treatment option for psoriatic arthritis. In cases where joint damage becomes severe and unresponsive to medical therapies, surgical interventions like joint replacement surgery may be necessary to restore function and alleviate pain. Lifestyle changes, such as regular exercise, joint protection techniques, and weight management, are also critical in managing psoriatic arthritis, as excess weight can worsen symptoms and increase disease severity. The treatment landscape for psoriatic arthritis continues to evolve, offering hope to patients with more targeted therapies and improved outcomes. As companies like UCB Biopharma, AbbVie, and Janssen advance their biologic portfolios, the future looks promising for psoriatic arthritis management. The competition in the biosimilar market is intensifying as companies introduce cost-effective alternatives to blockbuster biologics. In December 2024, Celltrion announced FDA approval for STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. Simultaneously, Biocon Biologics Ltd. is strengthening its position with positive Phase III results for YESINTEK, its biosimilar to ustekinumab, in adult patients with moderate to severe chronic plaque psoriasis. The pivotal randomized, double-blind, parallel-group study demonstrated comparable efficacy and safety to the reference biologic, STELARA, and the findings are being presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida. With the approval of STEQEYMA and the promising clinical outcomes for YESINTEK, these biosimilars are poised to challenge STELARA by offering cost-effective alternatives in key immunology indications. As pricing pressures and healthcare sustainability concerns drive the demand for biosimilars, these developments mark a significant shift in the treatment landscape, providing greater accessibility and affordability for patients while increasing competition in the immunology market. To know more about psoriatic arthritis treatment options, visit @ New Treatment for Psoriatic Arthritis The psoriatic arthritis market is buzzing with numerous companies advancing treatments to cater to the growing patient base. Several therapies are expected to enter the market during the forecast period, providing new hope for patients. Some of these potential therapies include ACELYRIN Inc.'s Izokibep, Novartis Pharmaceuticals' Secukinumab, UCB Biopharma SRL's Bimekizumab, and Bristol-Myers Squibb's Deucravacitinib. Additionally, AbbVie's Upadacitinib and Risankizumab, as well as Eli Lilly and Company's Ixekizumab, are also part of the promising pipeline. Other noteworthy therapies include Sun Pharma's ILUMYA/ILUMETRI, Bristol-Myers Squibb's SOTYKTU, and Affibody's Izokibep in collaboration with Acelyrin and Inmagene. With these advancements, the psoriatic arthritis treatment landscape is set for a major shift, offering patients more tailored and effective options. The companies involved in developing biosimilars include Alvotech, Teva, Biocon Biologics, Celltrion, Fresenius Kabi, and others. Discover which therapies are expected to grab major psoriatic arthritis market share @ Psoriatic Arthritis Market Report ILUMYA/ILUMETRI by Sun Pharma is an interleukin-23 (IL-23) inhibitor classified as a humanized, anti-IL-23p19 monoclonal antibody. It works by blocking inflammatory proteins (cytokines and chemokines) in the body. By inhibiting the effects of IL-23, ILUMYA helps control the release of other inflammatory proteins, including IL-17 and TNF-α. This mechanism reduces inflammation, decreases the number of inflammatory cells in psoriatic lesions, helps prevent plaque formation, and resolves tissue damage. The drug is currently undergoing evaluation in Phase III clinical development, actively recruiting subjects with active psoriatic arthritis who have prior exposure to anti-TNF agents, as well as those who are anti-TNF naïve. SOTYKTU, developed by Bristol-Myers Squibb, is the first and only novel oral selective tyrosine kinase 2 (TYK2) inhibitor being studied across multiple immune-mediated diseases. Deucravacitinib binds to the regulatory domain of the TYK2 enzyme, inhibiting its activation. This selective inhibition reduces the release of proinflammatory cytokines and chemokines, helping to control the inflammation associated with psoriatic arthritis and alleviating its signs and symptoms. Currently, the drug is being investigated for the treatment of psoriatic arthritis in a Phase III clinical trial. Izokibep, developed by Affibody in partnership with Acelyrin and Inmagene, is a unique antibody mimetic and a novel bispecific agent that potentially targets both subunits of the IL-17A homo-dimer and serum albumin. Affibody has entered into a partnership agreement with Acelyrin for the development and commercialization of izokibep and has completed a Phase II trial. As part of this agreement, Acelyrin obtained worldwide rights to izokibep, excluding selected Asian countries, where rights have been granted to Inmagene Biopharmaceuticals. In March 2024, Acelyrin announced the release of positive top-line results from the Phase IIb/III trial, indicating that izokibep was well-tolerated with a favorable safety profile. This drug is currently in Phase III clinical trial. Discover more about drugs for psoriatic arthritis in development @ Psoriatic Arthritis Clinical Trials The anticipated launch of these emerging therapies for psoriatic arthritis is poised to transform the market landscape in the coming years. As these cutting-edge treatments continue to mature and gain regulatory approval, they are expected to reshape the psoriatic arthritis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the psoriatic arthritis market size was USD 9 billion in 2021 and is expected to grow significantly in the coming years. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the condition. The anticipated launch of these therapies is also expected to attract new entrants to the psoriatic arthritis market, resulting in increased competition and innovation. DelveInsight's latest published market report titled " Psoriatic Arthritis Market Insight, Epidemiology, and Market Forecast – 2034" will help you discover which market leader is set to capture the largest market share. The report provides comprehensive insights into country-specific treatment guidelines, patient pool analysis, and epidemiology forecasts to help understand key opportunities and assess the market's underlying potential. The psoriatic arthritis market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of Psoriatic Arthritis Total Diagnosed Prevalent Cases of Psoriatic Arthritis Gender-specific Diagnosed Prevalent Cases of Psoriatic Arthritis Severity-specific Diagnosed Prevalent Cases of Psoriatic Arthritis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Psoriatic Arthritis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this psoriatic arthritis market report to assess the epidemiology forecasts, understand patient journeys, gain insights into KOLs' opinions about upcoming treatment paradigms, and identify the factors contributing to changes in the psoriatic arthritis market. Additionally, stay informed about the mitigating factors that can enhance your market position in the psoriatic arthritis therapeutic space. Related Reports Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Affibody, Kymera, Selection Therapeutics GmbH, Jiangsu HengRui Medicine Co., Ltd., Nimbus Lakshmi, Inc., Hansoh BioMedical R&D Company, Bio-Thera Solutions, ACELYRIN Inc., among others. Psoriatic Arthritis Epidemiology Forecast Psoriatic Arthritis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and Psoriatic Arthritis epidemiology trends. Ankylosing Spondylitis Market Ankylosing Spondylitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Ankylosing Spondylitis companies, including UCB, AbbVie, Pfizer, Astella, Amgen, Janssen Biotech, Pozen, Novartis, Iroko Pharmaceuticals, Syntex Pharmaceuticals, Horizon Pharma, Eli Lilly and Company, among others. Psoriasis Market Psoriasis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Psoriasis companies, including Amgen, Janssen, Abbvie, Novartis, AstraZeneca, Bausch Health, Eli Lilly, Sun Pharmaceutical, Janssen Biotech, UCB Inc., LEO Pharma, Promius Pharma, Mayne Pharma, Bausch Health Companies, MC2 Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalClinical ResultPhase 2

04 Mar 2025

·www.fiercepharma.com

Glenmark issues another recall, this time for nearly 1.5M bottles of generic ADHD drug

Glenmark Pharma is recalling nearly 1.5 million bottles of the attention-deficit/hyperactivity disorder drug atomoxetin. Glenmark Pharma, an India-based drug manufacturer that has been the focal point of a spate of recalls in recent years, has issued another. This time, the product pull covers about 1.48 million bottles of the generic attention-deficit/hyperactivity disorder (ADHD) drug atomoxetine.Eli Lilly previously sold the branded version of the drug, Strattera, but discontinued all strengths in 2023 after the arrival of generics.Unlike stimulant-based drugs that make up the bulk of ADHD treatment, including those like Vyvanse and Adderall, atomoxetine is a selective norepinephrine reuptake inhibitor (sNRI).The recall was triggered by the presence of unacceptable levels of N-nitroso atomoxetine, a possible carcinogen, in multiple Glenmark atomoxetine batches, according to the FDA. The voluntary pull, which began Jan. 29, covers bottles of the drug in strengths ranging from 10 mg to 100 mg, the FDA said on its Enforcement Report webpage. The ADHD drugs were manufactured in Glenmark’s facility in Goa, India, and were distributed nationwide. Glenmark has weathered a string of recalls in recent years due to both manufacturing and labelling issues.In June 2024, the company recalled 114 batches of 750 mg potassium chloride extended-release capsules—or roughly 47 million capsules—over concerns that they failed to dissolve properly.In December, the company recalled 90,528 bottles of the high blood pressure drug diltiazem hydrochloride in tablet and extended-release forms due to unacceptable levels of another N-nitroso compound, N-nitroso-Desmethyl-Diltiazem.In separate actions in 2023, Glemark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets used to treat high blood pressure; 37,200 bottles of Indomethacin, which is a non-steroidal anti-inflammatory used to treat pain and arthritis symptoms; and five lots (no bottle count provided) of Naproxen that is used to reduce fever or relieve mild pain.The previous year it recalled 98,307 packs of mometasone furoate topical solution, a corticosteroid lotion that treats skin conditions such as eczema, psoriasis, allergies and rash.

Clinical Result

18 Nov 2024

·www.drugs.com

Bleeding Risk Increased With NSAID Use for VTE Patients Receiving Anticoagulants

MONDAY, Nov. 18, 2024 -- Patients with venous thromboembolism (VTE) initiating oral anticoagulants have an increased risk for bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDs), according to a study published online Nov. 17 in the European Heart Journal . Søren Riis Petersen, from Aarhus University Hospital in Denmark, and colleagues conducted a nationwide cohort study of 51,794 VTE patients initiating oral anticoagulants between Jan. 1, 2012, and Dec. 31, 2022. Adjusted hazard ratios between NSAID use and hospital-diagnosed bleeding episodes were computed. The researchers found that the event rates for any bleeding per 100 person-years were 3.5 and 6.3 during periods without and with NSAID use, respectively (number needed to harm, 36 patients treated for one year). The adjusted hazard ratios for any bleeding associated with NSAID use versus nonuse were 2.09, 1.79, 3.30, and 4.10 overall, for ibuprofen, for diclofenac, and for naproxen, respectively. The adjusted hazard ratios associated with NSAID use versus nonuse were 2.24, 3.22, 1.36, 1.57, and 2.99 for gastrointestinal bleeding, intracranial bleeding, thoracic and respiratory tract bleeding, urinary tract bleeding, and anemia caused by bleeding, respectively. For anticoagulant and VTE subtypes, the results were consistent. "The common use of NSAIDs in patients with cardiovascular disease emphasizes the importance of being aware of the bleeding risks associated with their use," the authors write. Several authors disclosed ties to the pharmaceutical industry. Abstract/Full Text Editorial Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

AHA

100 Deals associated with Naproxen

External Link

KEGG	Wiki	ATC	Drug Bank
D00118	Naproxen	G02CC02 M01AE02 M02AA12	DB00788

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pain	China	Hubei Huazhong Pharmaceutical Co. Ltd.	01 Jan 1983
Gout	China	Hubei Huazhong Pharmaceutical Co. Ltd.	01 Jan 1982
Analgesia	Japan	Nipro ES Pharma KK	24 Jan 1978
Inflammation	Japan	Nipro ES Pharma KK	24 Jan 1978
Ankylosing Spondylitis	United States	Atnahs Pharma US Ltd.	11 Mar 1976
Juvenile Idiopathic Arthritis	United States	Atnahs Pharma US Ltd.	11 Mar 1976
Osteoarthritis	United States	Atnahs Pharma US Ltd.	11 Mar 1976
Rheumatoid Arthritis	United States	Atnahs Pharma US Ltd.	11 Mar 1976

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Low Back Pain	Phase 3	-	Targeted Medical Pharma, Inc.	01 Feb 2009
Toothache	Phase 2	United States	Iroko Pharmaceuticals LLC	01 Oct 2010
Peptic Ulcer	Phase 1	United Kingdom	Oxford Pharmascience Ltd.	01 May 2015
Rheumatic Diseases	Phase 1	United Kingdom	Oxford Pharmascience Ltd.	01 Feb 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03771612 (CTgov)	Early Phase 1	Inflammation	144	Naproxen (Naproxen)	xegwhadgdi(yartwhnvdn) = goiwqswktd utdzquljyz (ahhicwsatm, 10) View more	-	25 Feb 2025
				Placebos (Placebo)	xegwhadgdi(yartwhnvdn) = erthcfmepp utdzquljyz (ahhicwsatm, 10.5) View more
NCT05026320 (CTgov)	Phase 2	Contusions \| Soft Tissue Injuries	76	Placebo gel	dakeodtyke(wpvjwnhxfn) = lgmaowxkgq wjwbfywioj (iwkxpzlfxs, ozrbybfsef - gnsjbsgnrv) View more	-	22 Jan 2025
NCT02451748 (CTgov)	Phase 4	Rheumatoid Arthritis	32	Lab Work (DMARD's Responder and Non-Responder)	gkxqhgtvxd(maxryxlxun) = htqrzgjcuo fzmzguxept (hhszoduwav, bvaqpebkwy - fkolgajlbp) View more	-	10 Jul 2024
				Naproxen+Medrol+Hydroxychloroquine+humira+Prednisone+Lab Work+Triamcinolone+Sulfasalazine+Certolizumab pegol (CDP870, tradename Cimzia)+Methotrexate+Leflunomide (DMARD's Plus Cimzia (Certolizumab Pegol))	cmudqkmfli(jjcuzytbxi) = evyrbeavbx mskwcihfut (beieobmukj, 0.132) View more
NCT03347929 (Pubmed \| Pain) Manual	Phase 4	Sciatica	123	Naproxen 500 mg	lrgitvxlwu(wcfyguvpzx) = zrylzgyebk waoxrltddk (gkhhbbklbh ) View more	Negative	04 Jun 2024
				Placebo	-
NCT04694300 (CTgov)	Phase 4	Mouth and Tooth Diseases \| Acute Pain	30	Tramadol+Naproxen (Naproxen Sodium)	ptzoqodyzj(scfudytfep) = ufiynalven akteihoxbc (uqduopbmwy, meyyphaeft - xzktaxqvps) View more	-	16 May 2024
				Tramadol+Acetaminophen (Acetaminophen)	ptzoqodyzj(scfudytfep) = dkyodgkban akteihoxbc (uqduopbmwy, kvqhevvekk - ongrkaqwvb) View more
ISN WCN2024	Not Applicable	Nephrosis, Lipoid	1	Naproxen 500 mg	pxccxptfei(uhwucqpjzz) = tncjvyhyqd zgfvzqobvg (hzbmdfcbvv ) View more	Positive	01 Apr 2024
NCT02502006 (CTgov)	Phase 1	-	16	Celecoxib (Celecoxib)	ubdmzqiusb(wwngjlehyc) = ftjinztslo etaofjiriq (meuxyhmzkj, 1357) View more	-	13 Dec 2023
				Naproxen (Naproxen)	ubdmzqiusb(wwngjlehyc) = ztpeheabmr etaofjiriq (meuxyhmzkj, 66.8) View more
NCT03697720 (CTgov)	Phase 4	Dysmenorrhea \| Bladder pain	26	Naproxen	jgxkmsplln(ydzpybdwem) = pbyjingijq ybgwtmodsv (dukhopqwgu, 2.4) View more	-	18 Oct 2023
EULAR2022	Not Applicable	Non-radiographic axial spondyloarthritis	43	Continuous NSAIDs intake	xknxjmdtwy(znfkmxoixh) = toibnhesvx zkqrgvysps (rhvqjczdhz ) View more	Positive	01 Jun 2022
				Occasional NSAIDs intake	piecnuewhv(bmskzhcwus) = girtqzpqjn yizcamijqr (zyywoqqbfo )
NCT00346216 (PRECISION, Pubmed \| Eur Heart J Cardiovasc Pharmacother)	Phase 4	Arthritis	24,081	Celecoxib	araibvbxrc(fnulxrjqvz) = fbbqsphovy nfohijrvap (drapugicjb )	Positive	02 Mar 2022
				Ibuprofen	araibvbxrc(fnulxrjqvz) = bljosaettd nfohijrvap (drapugicjb )

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