Current Drug Safety[JOURNAL]
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200 papers
Azathioprine-induced Veno-occlusive Hepatotoxicity in a Patient with Myasthenia Gravis.
Dongre N, Kalita J, Misra UK
Curr Drug Saf · 2025 · PMID 38265400 · Publisher ↗
INTRODUCTION: Myasthenia gravis (MG) is an autoimmune disorder of post-synaptic neuromuscular junction characterised by fatigable muscle weakness and is treated with prednisolone with or without other immunosuppressants,...
INTRODUCTION: Myasthenia gravis (MG) is an autoimmune disorder of post-synaptic neuromuscular junction characterised by fatigable muscle weakness and is treated with prednisolone with or without other immunosuppressants, including azathioprine (AZA). Veno-occlusive hepatotoxicity of AZA is a rare complication in MG. CASE REPORT: We report a 35-year-old man with MG, was treated with pyridostigmine, prednisolone, and AZA for 5 years. He presented with abdominal pain and increased fatiguability for 7 days. His serum bilirubin and liver enzymes were elevated, and ultrasound revealed a dilated hepatic vein and portal vein suggestive of veno-occlusive liver disease. The clinical symptoms, liver functions, and ultrasound of the hepatobiliary system normalized after withdrawal of AZA. CONCLUSION: A possibility of AZA veno-occlusive hepatoxicity should be considered in a MG patient if presented with abdominal pain, elevated bilirubin and transaminases, and ultrasound showing dilatation of hepatic veins. Physicians should be aware of this complication because this toxicity is reversible following dose reduction or withdrawal of AZA.
Antidepressant-induced Paradoxical Anxiety, Akathisia, and Complex Vocal Tics in a Patient with Panic Disorder and Crohn's Disease: A Case Report.
Koh AHK, Loh SS, Lim L
Curr Drug Saf · 2024 · PMID 38251693 · Publisher ↗
BACKGROUND: Antidepressant-induced paradoxical anxiety is a fairly common phenomenon seen in patients who are initiated on antidepressants. However, akathisia is a very uncommon manifestation of antidepressants. Much mor...
BACKGROUND: Antidepressant-induced paradoxical anxiety is a fairly common phenomenon seen in patients who are initiated on antidepressants. However, akathisia is a very uncommon manifestation of antidepressants. Much more rarely, antidepressants are also associated with the emergence of motor and vocal tics. This case adds to the growing literature of rare adverse events induced by antidepressants and aims to stimulate future research into the mechanism and risk factors of this phenomenon. CASE PRESENTATION: In this case report, we describe a patient with panic disorder and co-morbid Crohn's disease who developed worsening anxiety, akathisia and vocal tics upon initiation of fluvoxamine. This is the first case report to describe the emergence of both akathisia and vocal tics in the same patient following antidepressant initiation. After discontinuation of fluvoxamine, the patient's symptoms resolved. CONCLUSION: Antidepressant-induced akathisia and tics are often distressing both to the patient and their loved ones, and can be very puzzling to the clinician. It is important for clinicians to recognise that, although rare, antidepressants can adverse effects. When these symptoms arise, it should prompt immediate discontinuation of the offending antidepressant.
Hepatitis E Virus in Individuals Undergoing Heparin Therapy: An Observational Serological and Molecular Study.
Mesquita JR, Santos-Silva S, Ferreira N … +3 more , Rivero-Juarez A, Gonçalves G, São José Nascimento M
Curr Drug Saf · 2024 · PMID 38204276 · Publisher ↗
INTRODUCTION: Heparin is derived from swine and has been suggested as a possible source of HEV. To study the potential risk of HEV infection associated with heparin treatment, two groups of individuals were compared. Ser...
INTRODUCTION: Heparin is derived from swine and has been suggested as a possible source of HEV. To study the potential risk of HEV infection associated with heparin treatment, two groups of individuals were compared. Sera from heparinized (N=93) and non-heparinized individuals (N=111) were tested for markers of acute HEV infection and anti-HEV IgG seroprevalence. METHODS: An acute HEV case was defined by the presence of anti-HEV IgM and/or HEV RNA. From the 93 heparinized individuals, one was positive for IgM and IgG anti-HEV and two were positive for HEV RNA (for both ORF3 and ORF2), and there were a total of two (2.2%) cases of current or recent HEV infection. From the 111 non-heparinized individuals, three were positive for IgM anti-HEV, one was positive for both IgM and IgG anti-HEV, and none was positive for HEV RNA, and there were a total of three (2.7%) cases of current or recent HEV infection. The difference between HEV cases in the heparinized individuals and the non-heparinized individuals was not statistically significant (2.2% vs. 2.7%; p = 0.799). RESULTS: Concerning IgG anti-HEV, it was detected in 32 individuals from the heparinized group and in 18 from the non-heparinized control group. A statistically significant difference was observed in the presence of anti-HEV IgG in heparinized individuals and controls (p = 0.003). CONCLUSION: This study has not found any association between heparin treatment and acute HEV infection, but has shown the use of therapeutic heparin as a risk factor for IgG anti-HEV seropositivity.
Treatment Modalities for Trigeminal Neuralgia and the Need for Vigilance in Monitoring Adverse Drug Events: A Case Report.
Addanki RND, Mannava AS, Velmurugan H … +1 more , Thangaraju P
Curr Drug Saf · 2024 · PMID 38204275 · Publisher ↗
INTRODUCTION: Trigeminal neuralgia is a rare condition characterised by paroxysms of intense pain in the distribution of the trigeminal nerve. This condition significantly diminishes the patient's quality of life, and th...
INTRODUCTION: Trigeminal neuralgia is a rare condition characterised by paroxysms of intense pain in the distribution of the trigeminal nerve. This condition significantly diminishes the patient's quality of life, and the side effects from chronic use of medications for symptomatic relief further exacerbate their distress. CASE DESCRIPTION: The case report discusses a patient diagnosed with Trigeminal Neuralgia who commenced carbamazepine treatment. The report tracks the disease's progression, medication adjustments, and the eventual emergence of vertigo due to long-term carbamazepine use. CONCLUSION: The article covers fundamental information about trigeminal neuralgia and its management and also offers a comprehensive review of the basics of vertigo. It delves into carbamazepine's mechanism of action and its associated side effects. The paper also looks at prospective therapy changes that could improve patients' quality of life.
Tumor Necrosis Alpha (TNF-α) Antagonists Used in Chronic Inflammatory Rheumatic Diseases: Risks and their Minimization Measures.
Lakhmiri R, Cherrah Y, Serragui S
Curr Drug Saf · 2024 · PMID 38204274 · Publisher ↗
Tumor necrosis factor alpha (TNF- α) inhibitors are widely employed for the management of chronic inflammatory rheumatism. However, their usage carries significant risks, including site and infusion reactions, serious in...
Tumor necrosis factor alpha (TNF- α) inhibitors are widely employed for the management of chronic inflammatory rheumatism. However, their usage carries significant risks, including site and infusion reactions, serious infections, malignancy, heart failure autoimmune and demyelinating disorders. These risks are comprehensively outlined in risk management plans (RMPs) associated with these molecules. RMP provides information on the safety profile of a medicinal product as well as the measures that will be taken to minimize risks; these are known as risk minimization measures. These measures are divided into routine measures related to elements, such as the summary of product characteristics, labeling, pack size, package leaflet, or legal supply status of the product, while additional measures may include educational programs, including tools for healthcare providers and patients, controlled access or pregnancy prevention programs, among others. Additional measures can consist of one or more interventions that need to be implemented in a sustainable way in a defined target group, while respecting the timing and frequency of any intervention and procedures to reach the target population. An evaluation of the effectiveness of these measures is required to determine whether or not an intervention has been effective. This comprehensive review offers an in-depth exploration of the current treatment, uses, and associated risks of TNF-α inhibitors. Additionally, it provides a detailed account of risk minimization measures and risk management practices while shedding light on their real-world implementation and effectiveness.
Cardiac Toxicity in the Treatment of Light Chain Amyloidosis: Systematic Review of Clinical Studies.
Jattin-Balcázar JJ, Quiroga-Ramírez PA
Curr Drug Saf · 2024 · PMID 38204273 · Publisher ↗
BACKGROUND: Light chain amyloidosis (AL) is a progressive and a fatal disease that primarily affects cardiac tissue. Although the current approach to anti-amyloidosis treatments has managed to reduce amyloidosis morbimor...
BACKGROUND: Light chain amyloidosis (AL) is a progressive and a fatal disease that primarily affects cardiac tissue. Although the current approach to anti-amyloidosis treatments has managed to reduce amyloidosis morbimortality, the dynamics of cardiac adverse events are unknown. OBJECTIVE: to provide evidence about reported cardiac toxicity during treatment of AL amyloidosis through a systematic review of the literature. METHODS: A search was performed for registered clinical trials on ClinicalTrials.gov filtered for AL amyloidosis up to December 31, 2022. Studies were filtered by those that reported intervention in patients with AL amyloidosis and that had reported adverse events. The type of study, the intervention performed, and the frequency of reported cardiac adverse events were discriminated from each trial. RESULTS: 25 clinical trials were analyzed, representing a population of 1,542 patients, among whom 576 (38.95%) adverse events were reported, 326 being serious (SAE) and 242 nonserious (nSAE). The most frequent SAEs were cardiac failure, atrial fibrillation, and cardiac arrest, while the most frequent nSAEs were palpitations, atrial fibrillation, and sinus tachycardia. CONCLUSION: cardiac toxicity during treatment for amyloidosis seems common, and it is important to evaluate the relationship of therapies with its occurrence.
Natural Flavonoids: Fortifying Renal Defence Mechanism.
Jain T, Singh MP, Gohil KJ
Curr Drug Saf · 2025 · PMID 38204272 · Publisher ↗
BACKGROUND: The kidneys, intricate organs responsible for maintaining fluid and electrolyte balance, are susceptible to damage from diverse nephrotoxic insults, including drugs, toxins, and metabolic disorders. In recent...
BACKGROUND: The kidneys, intricate organs responsible for maintaining fluid and electrolyte balance, are susceptible to damage from diverse nephrotoxic insults, including drugs, toxins, and metabolic disorders. In recent years, flavonoids, bioactive compounds abundant in fruits, vegetables, and herbal extracts, have emerged as promising candidates for renal protection due to their potent antioxidant and anti-inflammatory properties. METHODS: We have collected the data that supported this idea to conduct a comprehensive review by using scientific databases, such as Pub Med ®, ScienceDirect ®, Google Scholar ®, and MEDLINE ®. An attempt was made to refer to all English-language articles published between 2000 to 2020 using keywords like flavonoids potential in nephrotoxicity and nephrotoxicity treatment approaches with herbal remedies. CONCLUSION: This comprehensive review delves into the molecular mechanisms underlying the reno-protective effects of flavonoids. By scavenging reactive oxygen species, inhibiting inflammatory mediators, and modulating intracellular signalling pathways, flavonoids can mitigate oxidative stress and inflammation, thereby preserving renal function and integrity. Preclinical studies have demonstrated the potential of specific flavonoids in ameliorating drug-induced nephrotoxicity, renal ischemia-reperfusion injury, diabetic nephropathy, and other kidney diseases. Furthermore, epidemiological evidence highlights the inverse relationship between flavonoid intake and the risk of developing kidney diseases. Nevertheless, understanding the molecular mechanisms of flavonoids in nephroprotection offers exciting prospects for developing novel therapeutic strategies to combat kidney diseases and promote kidney health.
Unveiling the Latest Breakthroughs: A Comprehensive Review of the Therapeutic Activity and Safety Profile of .
Saifi A, Sharma A, Chaudhary A … +3 more , Siddiqui N, Ashwlayan VD, Singh B
Curr Drug Saf · 2024 · PMID 38204271 · Publisher ↗
The use of herbal drugs as alternative and complementary medicine has increased in popularity, raising concerns about their safety profile. Aloe vera, a plant with diverse therapeutic properties, has been extensively use...
The use of herbal drugs as alternative and complementary medicine has increased in popularity, raising concerns about their safety profile. Aloe vera, a plant with diverse therapeutic properties, has been extensively used for centuries. This review aims to assess the therapeutic activity and safety profile of . A comprehensive literature search was conducted to gather relevant information from various biomedical databases. The chemical composition, mechanism of action, and therapeutic activities of were analyzed. Aloe vera contains numerous active components such as vitamins, enzymes, minerals, sugars, lignin, saponins, and anthraquinones. Its mechanisms of action involve collagen synthesis, anti-inflammatory effects, immune modulation, laxative properties, and antiviral activity. has demonstrated potential therapeutic benefits in wound healing, diabetes management, liver and kidney protection, and glycemic control. However, it is essential to consider potential side effects, such as skin irritation and allergic reactions. This review provides evidence-based information to improve patient safety and promote informed decisions regarding the use of as a therapeutic agent.
Cyclophosphamide Toxicity in Pediatric Nephrotic Syndrome Patient: A Case Report and Literature Review.
Patil S, Patil MV, Bagalkotkar A … +1 more , Wali S
Curr Drug Saf · 2024 · PMID 38204270 · Publisher ↗
BACKGROUND: Primary membranous nephropathy is a rare presentation in children. Patients unresponsive to steroids and experiencing frequent relapse are considered steroid-resistant. They often require complex treatment re...
BACKGROUND: Primary membranous nephropathy is a rare presentation in children. Patients unresponsive to steroids and experiencing frequent relapse are considered steroid-resistant. They often require complex treatment regimens consisting of immunosuppressants like cyclophosphamide, tacrolimus, and cyclosporin A. CASE: In the present case, a 5-year-old child was suffering from steroid-resistant nephrotic syndrome for the past 10 months. He was initially treated with prednisolone 20mg but was subsequently found to be steroid-resistant. A renal biopsy revealed primary podocytopathy with immunocomplex deposits in podocyte tissues, suggesting primary membranous nephropathy as the cause of SRNS (steroid-resistant nephrotic syndrome). Cyclophosphamide 25mg twice daily was added to the treatment plan since the child did not tolerate tacrolimus therapy. During a subsequent follow-up, the physician reduced the cyclophosphamide 25mg dose to once a day, but parents misinterpreted this, and the child received a larger dose, cyclophosphamide 25mg, four times a day for 20 days. This resulted in cyclophosphamide toxicity-induced neutropenia, alopecia and posing the child at greater risk of sepsis. CONCLUSION: Nephrotic syndrome is a chronic disease that demands extensive treatment plans and strict monitoring. Medication errors are common among parents or caregivers of pediatric patients. This case is a take-home message emphasizing the significance of patient-centered communication in preventing medication errors. A clinical pharmacist can aid in conveying simple and unambiguous information to parents or caregivers.
Association of Cardiovascular Events with COVID-19 Vaccines Using Vaccine Adverse Event Reporting System (VAERS): A Retrospective Study.
Amir M, Latha S, Sharma R … +1 more , Kumar A
Curr Drug Saf · 2024 · PMID 38031796 · Publisher ↗
BACKGROUND: COVID-19 vaccines have played a crucial role in reducing the burden of the global pandemic. However, recent case reports have indicated the association of the COVID- 19 vaccines with cardiovascular events but...
BACKGROUND: COVID-19 vaccines have played a crucial role in reducing the burden of the global pandemic. However, recent case reports have indicated the association of the COVID- 19 vaccines with cardiovascular events but the exact association is unclear so far. OBJECTIVE: Therefore, the objective of the current study is to find out the association of cardiovascular events with COVID-19 vaccines. METHODS: The COVID-19 Vaccine Knowledge Base (Cov19VaxKB) tool was used to query the Vaccine Adverse Event Reporting System (VAERS) database. The proportional reporting ratio [PRR (≥2)] with associated chi-squared value (>4), and the number of cases > 0.2% of total reports, was used to assess the association of COVID-19 vaccines with cardiovascular events. RESULTS: A total of 33,754 cases of cardiovascular events associated with COVID-19 vaccines were found in the Cov19VaxKB tool. The cases were observed in different age groups (18-64, and 65 years and above) and gender. The disproportionality measures indicate a statistically significant association between cardiovascular events and COVID-19 vaccines. CONCLUSION: The current study identified a signal of various cardiovascular events with the COVID-19 vaccines. However, further causality assessment is required to confirm the association.
Preface.
Dodd S
Curr Drug Saf · 2024 · PMID 38009476 · Publisher ↗
Abstract loading — click title to view on PubMed.
Identification of Novel Signals Associated with US-FDA Approved Drugs (2013) Using Disproportionality Analysis.
Raghuvanshi S, Rahman MA, Posa MK … +1 more , Kumar A
Curr Drug Saf · 2024 · PMID 37990902 · Publisher ↗
BACKGROUND: Drugs are related with various adverse drug reactions (ADRs), however, many unexpected ADRs of drugs are reported through post-marketing surveillance. AIM: The current study's goal is to uncover potential sig...
BACKGROUND: Drugs are related with various adverse drug reactions (ADRs), however, many unexpected ADRs of drugs are reported through post-marketing surveillance. AIM: The current study's goal is to uncover potential signals connected with FDA-approved medications in the United States (2013). METHODS: Open Vigil 2.1-MedDRA-v24 (data 20004Q1-2021Q3) was used as a tool to query the FAERS data. To find possible signals, disproportionality measures such as Proportional Reporting Ratio (PRR 2) with associated Chi-square value, Reporting Odds Ratio (ROR 2) with 95% confidence interval, and case count (3) were calculated. RESULTS: A total of eight potential signals were identified with five drugs. Positive signals were found with pomalidomide, canagliflozin, dolutegravir sodium, macitentan and ibrutinib. CONCLUSION: However, further causality assessment is required to confirm the association of these drugs with identified potential signals.
A Review of Drug Abuse, Misuse, and Related Laboratory Challenges.
Ranjkeshzadeh H, Sepahi S, Zare-Zardini H … +3 more , Taghavizadeh Yazdi ME, Ghorani-Azam A, Jafari A
Curr Drug Saf · 2024 · PMID 37957844 · Publisher ↗
Various definitions can be considered for drugs and substance abuse. According to the National Institute on Abuse, the use of an over-the-counter drug in a different way than that prescribed to experience or arouse emoti...
Various definitions can be considered for drugs and substance abuse. According to the National Institute on Abuse, the use of an over-the-counter drug in a different way than that prescribed to experience or arouse emotion is a simple form of drug abuse. The World Health Organization (WHO) also defines drug abuse as the persistent or sporadic use of drugs that are incompatible or unrelated to acceptable medical practice. With the increasing non-therapeutic use of prescription drugs, serious related consequences have also increased. Therefore, there is a need to know more precisely about the types of substances and drug abuse, which is the most important part of diagnosis and recognizing the tests that cause false positive and negative results. The purpose of this review article is to collect and summarize the most important and more common types of drugs of abuse and review the drugs that cause false results in screening tests. In addition, the most common detection methods of the drug will be reviewed and the advantages and drawbacks of each method will be discussed. In this article, we aimed to point out all the facts about the emerging problems in drug abuse, the methods of screening, and the possible false results in addition to troubleshooting strategies.
Pharmacists' Medication Reconciliation Interventions During Admission and Transfer from an Emergency Department at a Tertiary Care Hospital: A Randomized Pilot Study and Evaluation of Physician and Patient Perceptions.
Joseph AG, Saji S, Kumbhar AN … +3 more , Shivakumar G, Bhandari R, Ganachari MS
Curr Drug Saf · 2024 · PMID 37702160 · Publisher ↗
AIM: The study aimed to assess the impact of pharmacist interventions during the transition of care. BACKGROUND: Medication discrepancies can occur at various levels of transition, such as during admission, the transitio...
AIM: The study aimed to assess the impact of pharmacist interventions during the transition of care. BACKGROUND: Medication discrepancies can occur at various levels of transition, such as during admission, the transition from emergency to special wards or from special to general wards, and during discharge. Discrepancies can be detected through the process of medication reconciliation. OBJECTIVE: The objective of the study was to compare discrepancies among patients exposed to pharmacist intervention groups and those who were not and assess the perception of healthcare professionals and patients towards integrating pharmacists in the transition care process. METHODS: A pharmacist-led interventional study was conducted for six months on patients above 18 years of age and either sex who were admitted to the emergency department, had chronic diseases, and subsequently transferred to another department (any). The patients were randomized into intervention and control groups. The pharmacist performed a medication reconciliation and medication review to identify discrepancies in every transition in both the groups, and then reported to the treating physician to resolve in the intervention group. RESULTS: Among the 73 patients recruited in the study, 152 discrepancies were identified. The total discrepancies observed in the control and intervention groups were 78 (51.3%) and 74 (48.6%), respectively. The majority, 35.53%, were found during the transition from emergency to special wards. The physician, upon pharmacist recommendations, accepted and resolved 48 discrepancies in the intervention group. The healthcare professional acceptance rate of pharmacist interventions was 64.86%. CONCLUSION: The transitions of care are at risk for errors due to medication discrepancies, and pharmacists could potentially identify and resolve discrepancies. Healthcare professionals and patients reported to be satisfied by the involvement of clinical pharmacists in the healthcare team.
Interactions Between Antimicrobial Peptides and Targets Responsible for their Nephrotoxic Action: Molecular Dynamics Simulations.
Lisnyak Y, Martynov A, Farber B
Curr Drug Saf · 2024 · PMID 37670709 · Publisher ↗
OBJECTIVES: Polymyxin is the last line of defense against resistant forms of microorganisms, but it has significant nephrotoxicity. One of the directions in reducing the nephrotoxicity of polymyxin is to modify the charg...
OBJECTIVES: Polymyxin is the last line of defense against resistant forms of microorganisms, but it has significant nephrotoxicity. One of the directions in reducing the nephrotoxicity of polymyxin is to modify the charge of the molecule and accordingly, to change the topicity of the polymyxin derivative to the renal megalin. Such modification can lead to a decrease in the accumulation of polymyxin in the kidneys and reduce its toxicity while maintaining its antimicrobial properties. The study aimed to investigate the structural aspects of polymyxin nephrotoxicity at the atomic level to promote the more purposeful development of the polymyxin's derivatives with the lower nephrotoxic action. MATERIALS AND METHODS: The molecular dynamics simulations of the complexes of polymyxin B and its derivative NAB7061 (that carries only three positive charges located within the macrocycle) with megalin were performed in program package YASARA structure with explicit water (TIP3P) and ions (0.9 % NaCl) in NPT ensemble using the AMRER03 force field. After 10 ns equilibration, each system was simulated at 298 K and pH 7.4 for a 25 ns production phase. Simulations were run twice for each molecular system. RESULTS: By molecular dynamics simulations, the possibility was shown for polymyxin to form a stable complex with two neighbor structural domains of megalin in accord with the universal mechanism of binding the cationic ligands by ligand-binding CR repeats of the LDLR-family receptors. It was reported that interactions of megalin with polymyxin were stronger than with its derivative having no positively charged groups outside the macrocycle. The structural prerequisites of these differences were revealed, explaining the less nephrotoxicity of such derivatives compared to polymyxin. CONCLUSION: Comparative molecular dynamics simulations of megalin interactions with polymyxin B and its derivative NAB7061, which carries no positive charges outside the macrocycle, revealed the possible structural prerequisites for the lower nephrotoxic action of such polymyxin derivatives. The weakening of polymyxins binding with megalin may become an effective preventive measure against polymyxin-induced nephrotoxicity.
Atezolizumab Lung Toxicity: Importance of Combination Treatment On The Edge of Life, A Case Report.
Koc AS, Can O, Kobak S
Curr Drug Saf · 2024 · PMID 37622710 · Publisher ↗
BACKGROUND: Lung cancer is one of the most common and mortal cancers worldwide. According to pathological and clinical groups, treatments vary, and a tailored approach is considered. Adjuvant therapies, such as chemother...
BACKGROUND: Lung cancer is one of the most common and mortal cancers worldwide. According to pathological and clinical groups, treatments vary, and a tailored approach is considered. Adjuvant therapies, such as chemotherapy, radiation, and immune checkpoint inhibitors (ICI), are recommended by recent guidelines for patients with locally advanced cancer. OBJECTIVE: This study aimed to report the case of a patient with stage 2B squamous cell lung carcinoma who was managed for pulmonary toxicity after receiving adjuvant chemotherapy and atezolizumab treatment. CASE REPORT: A 66-year-old male patient received chemotherapy and immunotherapy after surgery for squamous cell lung cancer. A diagnosis of atezolizumab-associated pneumonitis was made using laboratory tests and imaging due to the patient's worsening dyspnea after treatment. Due to the patient's rapid progression, pulse steroid and MMF therapy were administered concurrently. When Klebsiella pneumoniae growth was detected in the sputum culture during the follow-up, IVIg was used to supplement the medication. The patient showed significant clinical and radiological improvement. CONCLUSION: In this study, we present an atezolizumab-induced pneumonitis case of a squamous cell lung cancer patient. It may be life-saving not to avoid aggressive treatment approaches by combining the steps of guideline recommendations in patients with rapidly progressive pneumonitis.
Evaluation of High-dose Standard-dose of Dexamethasone on Mortality among the Mechanically Ventilated COVID-19 Patients.
Kale-Pradhan PB, Pacitto R, Giuliano CA … +1 more , Johnson LB
Curr Drug Saf · 2024 · PMID 37592771 · Publisher ↗
INTRODUCTION: Anti-inflammatory agents like dexamethasone (DEX) are a mainstay of treatment for COVID-19. Despite randomized trials demonstrating that a 6 mg daily dose of DEX improved patient outcomes in hospitalized CO...
INTRODUCTION: Anti-inflammatory agents like dexamethasone (DEX) are a mainstay of treatment for COVID-19. Despite randomized trials demonstrating that a 6 mg daily dose of DEX improved patient outcomes in hospitalized COVID-19 patients receiving oxygen, clinicians often prescribe higher doses of corticosteroids without evidence to support this practice. The purpose of this study was to compare outcomes of ventilated COVID-19 patients who received standard dose (SD) versus high dose (HD) DEX. METHODS: This was a multi-site, retrospective, observational study on ventilated COVID-19- positive patients who received DEX for at least three days between June 1, 2020, and January 31, 2022. The primary outcome of this study was the association between mortality and SD (<6 mg daily) versus HD (>10 mg daily) DEX in ventilated COVID-19 patients. Secondary outcomes included average blood glucose (BG), number of BG readings above 200, incidence of bacterial nosocomial infection, ventilator-free days, length of stay (LOS), and ICU LOS. RESULTS: Of the 212 included patients, 53 (25%) received SD DEX, and 159 (75%) received HD DEX. There was no significant effect of DEX dose on mortality, number of BG readings >200, incidence of nosocomial infections, LOS, or ventilator-free days (p >0.05). After controlling for confounding factors, no difference in mortality persisted (OR 1.34 95% CI 0.62- 2.90). Average daily BG and ICU LOS were significantly greater in the HD group compared to the SD group (p = 0.003, p = 0.019, respectively). CONCLUSION: There was no association between HD DEX and mortality among ventilated COVID- 19 patients compared to SD DEX. Moreover, HD DEX is associated with detrimental effects such as prolonged ICU LOS and higher average daily BG. This study supports the use of SD DEX in ventilated COVID-19 patients.
Chemotherapy-Induced Peripheral Neuropathy Impacts Quality of Life and Activities of Daily Living of Brazilian Multiple Myeloma Patients.
de Miranda Drummond PL, Dos Santos RMM, Silveira LP … +6 more , Malta JS, Moreira Reis AM, Costa NL, de Paula E Silva RO, Fagundes EM, de Pádua CAM
Curr Drug Saf · 2024 · PMID 37592770 · Publisher ↗
BACKGROUND: Survival in multiple myeloma (MM) has improved in the past years with the introduction of immunomodulators and proteasome inhibitors. However, chemotherapyinduced peripheral neuropathy (CIPN) is associated wi...
BACKGROUND: Survival in multiple myeloma (MM) has improved in the past years with the introduction of immunomodulators and proteasome inhibitors. However, chemotherapyinduced peripheral neuropathy (CIPN) is associated with both drug classes affecting Health- Related Quality of Life (HRQoL) and activities of daily living (ADL). OBJECTIVE: We evaluated CIPN in MM patients to identify associated factors and impacts on HRQoL and ADL. METHODS: This is a cross-sectional study with Brazilian patients from public and private health services. Patients were interviewed using validated tools to measure CIPN and HRQoL, along with sociodemographic and clinical questions. Logistic regression was used to assess the association of CIPN with sociodemographic, clinical, and HRQoL variables. RESULTS: In total, 217 patients were eligible for the study. The median age was 67, 50.9% were women, 51.6% had low income, 47.5% had low education, and 55.3% attended private health services. The chemotherapy regimen most used was the combination of cyclophosphamide, thalidomide, and dexamethasone (17.5%) among the 24 types of regimens found. Most patients (90.3%) had at least one CIPN symptom: 62.7% were severe, and 51.62% were extremely bothered ADL. Numbness was the most common symptom (40.6%). CIPN was independently associated with education, hospitalization, chemotherapy, side effects, disease symptoms, and global health status in HRQoL. CONCLUSION: MM patients showed a high frequency of CIPN, which affected ADL and impaired HRQoL. Early and accurate detection of CIPN and dose management in patients with thalidomide and bortezomib-based regimens should be performed to provide better treatment outcomes and avoid permanent disabilities.
Incidence and Severity of Adverse Drug Reactions in Medical Intensive Care Unit.
Shaikh S, Raut A, Jambhale P … +2 more , Iyer S, Shah J
Curr Drug Saf · 2024 · PMID 37587829 · Publisher ↗
BACKGROUND: Adverse drug reactions (ADRs) curtail patients' quality of life by virtue of increasing therapeutic complexity and rising multimorbidity. In India, the frequency of ADRs for individual drugs and their economi...
BACKGROUND: Adverse drug reactions (ADRs) curtail patients' quality of life by virtue of increasing therapeutic complexity and rising multimorbidity. In India, the frequency of ADRs for individual drugs and their economic burdens are rarely evaluated. This study aimed at identifying the incidence and severity of ADRs leading to hospitalization (ADRA) and occurring during a hospital stay (ADRH). OBJECTIVE: The objective of this study is to evaluate the incidence the incidence and severity of ADRs in the ICU and their impact on the duration of hospitalization, along with the cost incurred to treat ADRs in the ICU. METHODS: Demographic, clinical, and pharmacological data on patients admitted to the ICU were collected, analyzed and evaluated for ADRs. According to the setting analyzed, a descriptive analysis of the reactions, suspected medicines, and associated factors was undertaken. RESULTS: A total of 208 patients were admitted to the ICU during the study period, of which ADRA contributed 9.1% of the incidence rate and 8.1% of ADRH in 36 patients. Males had a higher incidence of ADRs than females. Patients who had ADRs had a substantially longer length of stay than those who did not. Electrolyte disturbance was the most commonly found ADR. According to the Hartwig scale and WHO-causality scale, 88.9% were moderate, and 97.2% were possible ADRs, respectively. CONCLUSION: In this study, a similar incidence rate of ADRA and ADRH was observed. The average cost for treating ADRA was higher than that for treating ADRH. As a result, identifying and preventing these reactions is critical, as they cause the patient greater suffering.
Amphotericin-B-Induced Chronic Kidney Disease in a Post-COVID-19 Patient with Widespread Rhinocerebral Mucormycosis and Pneumonia: A Case Report.
Johri N, Choudhary A, Rawat U … +1 more , Vengat M
Curr Drug Saf · 2024 · PMID 37537934 · Publisher ↗
BACKGROUND: The COVID-19 pandemic has posed a unique challenge to the medical community due to potential co-infections with bacteria and fungi. We report a case of Rhino cerebral mucormycosis infection in a 67-year-old p...
BACKGROUND: The COVID-19 pandemic has posed a unique challenge to the medical community due to potential co-infections with bacteria and fungi. We report a case of Rhino cerebral mucormycosis infection in a 67-year-old patient after recovery from COVID-19. OBJECTIVE: To report a case of Rhino cerebral mucormycosis in a 67-year-old patient with preexisting health conditions after recovering from COVID-19 and to highlight the importance of early detection and treatment of co-infections in patients with pre-existing health conditions. CASE PRESENTATION: The patient had pre-existing health conditions, including uncontrolled diabetes, hypertension, and Chronic obstructive pulmonary disease (COPD), which made him more vulnerable to complications after COVID-19. He was admitted to the hospital after experiencing a dark discharge from his left eye, later confirmed to be due to mucormycosis. Histopathological examination revealed invasive mucormycosis, highlighting the importance of early detection and treatment. However, the patient experienced Acute kidney injury (AKI) after only 5 days of treatment with conventional amphotericin B, underscoring the need for careful monitoring and adjustment of treatment regimens. DISCUSSION: The case underscores the need for early detection and treatment of co-infections in vulnerable patients. The patient's pre-existing conditions and immunocompromised state made him more susceptible to the infection. The case also highlights the importance of careful monitoring and adjustment of treatment regimens to minimize the risk of adverse effects. CONCLUSION: While COVID-19 has presented challenges and uncertainties, it has also provided valuable insights into the interactions between infectious agents and the human body. Continued research and vigilance are necessary to mitigate the impact of co-infections and improve outcomes for patients.
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