Expert Opinion on Drug Safety

Article	Citations
Tackling antimicrobial resistance across sub-Saharan Africa: current challenges and implications for the future	53
Newer formulations of intravenous iron: a review of their chemistry and key safety aspects – hypersensitivity, hypophosphatemia, and cardiovascular safety	50
Long-term safety of ketamine and esketamine in treatment of depression	47
Gastrointestinal and cardiovascular adverse events associated with NSAIDs	44
Efficacy and safety of biologics and small molecules for psoriasis in pediatric and geriatric populations. Part II: focus on elderly patients	42
A real-world pharmacovigilance study of axitinib: data mining of the public version of FDA adverse event reporting system	38
Efficacy and safety of biologics and small molecules for psoriasis in pediatric and geriatric populations. Part I: focus on pediatric patients	38
Chemotherapy in patients with early breast cancer: clinical overview and management of long-term side effects	35
Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines	34
Tocilizumab in COVID-19: a study of adverse drug events reported in the WHO database	31
Inclisiran: a small interfering RNA strategy targeting PCSK9 to treat hypercholesterolemia	30
Vitiligo induced by immune checkpoint inhibitors in melanoma patients: an expert opinion	28
Efficacy and safety of racemic ketamine and esketamine for depression: a systematic review and meta-analysis	27
The association between glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and suicidality: reports to the Food and Drug Administration Adverse Event Reporting System (FAERS)	26
Use of medications during pregnancy and breastfeeding for Crohn’s disease and ulcerative colitis	26
Cemiplimab for the treatment of advanced cutaneous squamous cell carcinoma	26
Drug safety evaluation of tildrakizumab for psoriasis: a review of the current knowledge	24
The therapeutic potential of psilocybin: a systematic review	24
Bimekizumab treatment in patients with moderate to severe plaque psoriasis: a drug safety evaluation	24
Current and emerging long-acting antipsychotics for the treatment of schizophrenia	23
Vortioxetine in major depressive disorder: from mechanisms of action to clinical studies. An updated review	23
Assessment of adverse events associated with remdesivir use for coronavirus disease 2019 using real-world data	21
Antifungal agents and the kidney: pharmacokinetics, clinical nephrotoxicity, and interactions	21
Safety and efficacy of pharmacologic agents used for rapid tranquilization of emergency department patients with acute agitation or excited delirium	20
Gastroenterological safety of IL-17 inhibitors: a systematic literature review	19

Antimicrobial resistance and the post antibiotic era: better late than never effort	19
The role of GLP-1 receptor agonists during COVID-19 pandemia: a hypothetical molecular mechanism	19
Safety and efficacy of P2Y12inhibitor monotherapy in patients undergoing percutaneous coronary interventions	18
Tafenoquine: a toxicity overview	18
Thalidomide: history, withdrawal, renaissance, and safety concerns	18
Deprescribing in migraine	18
The treatment of glaucoma using topical preservative-free agents: an evaluation of safety and tolerability	18
Prevalence, characteristics, and reporting of adverse drug reactions in an Australian hospital: a retrospective review of hospital admissions due to adverse drug reactions	16
Safety issues of psilocybin and LSD as potential rapid acting antidepressants and potential challenges	16
Current strategies for managing intestinal failure-associated liver disease	16
Efficacy and safety of CDK4/6 and PI3K/AKT/mTOR inhibitors as second-line treatment in postmenopausal patients with hormone receptor-positive, HER-2-negative metastatic breast cancer: a network meta-a	16
Harm related to recreational ketamine use and its relevance for the clinical use of ketamine. A systematic review and comparison study	16
Risks and benefits of reducing the number of drugs to treat HIV-1 infection	16
Oral isotretinoin for acne: a complete overview	15
Safety and tolerability of spesolimab in patients with ulcerative colitis	15
An umbrella review of systematic reviews on contributory factors to medication errors in health-care settings	15
Online information discrepancies regarding safety of medicine use during pregnancy and lactation: an IMI ConcePTION study	14
Evaluating safety in hyaluronic acid lip injections	14
Safety profile of D-penicillamine: a comprehensive pharmacovigilance analysis by FDA adverse event reporting system	14
An update on phosphate binders for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis: a review of safety profiles	14
Serious adverse events with tedizolid and linezolid: pharmacovigilance insights through the FDA adverse event reporting system	14
Improving the safety of intravenous iron treatments for patients with chronic kidney disease	14
Safety and tolerability of preventive treatment options for chronic migraine	13
Current approaches to overcome the side effects of GnRH analogs in the treatment of patients with uterine fibroids	13
Safety of dupilumab in patients with atopic dermatitis: expert opinion	13
A systematic review on pediatric medication errors by parents or caregivers at home	13
Safety review of anti-VEGF therapy in patients with myopic choroidal neovascularization	13
The efficacy and safety of adjunctive intranasal esketamine treatment in major depressive disorder: a systematic review and meta-analysis	13
A long-term open-label safety study of galcanezumab in Japanese patients with migraine	12
The effect of patient sex on the efficacy and safety of anticancer immunotherapy	12
The safety of current treatment options for advanced esophageal cancer after first-line chemotherapy	12
The safety of current pharmacotherapeutic strategies for osteosarcoma	12
Remdesivir for the treatment of COVID 19: review of the pharmacological properties, safety and clinical effectiveness	12
Psychopharmacology of Williams syndrome: safety, tolerability, and effectiveness	12
OnabotulinumtoxinA for the prophylactic treatment of headaches in adult patients with chronic migraine: a safety evaluation	12
Expert opinion on sonidegib efficacy, safety and tolerability	11
Exocrine pancreatic insufficiency and somatostatin analogs in patients with neuroendocrine neoplasia	11
Adverse effects of proton pump inhibitors (PPIs) on the renal system using data mining algorithms (DMAs)	11
Does the gut microbiome mediate antipsychotic-induced metabolic side effects in schizophrenia?	11
Risk of invasive fungal infections among patients treated with disease modifying treatments for multiple sclerosis: a comprehensive review	11
Long-term efficacy and safety of botulinum toxin treatment for cervical dystonia: a critical reappraisal	11
Safety review of tenofovir disoproxil fumarate/emtricitabine pre-exposure prophylaxis for pregnant women at risk of HIV infection	11
Safety and efficacy of anakinra as first-line or second-line therapy for systemic onset juvenile idiopathic arthritis - data from the German BIKER registry	11
Investigating the root cause of N-nitrosodimethylamine formation in metformin pharmaceutical products	11
Systematic review and meta-analysis on the safety of dalbavancin	11
Risks of molecular targeted therapies to fertility and safety during pregnancy: a review of current knowledge and future needs	10
Persistent sexual dysfunction after SSRI withdrawal: a scoping review and presentation of 86 cases from the Netherlands	10
Sexual dysfunction with major depressive disorder and antidepressant treatments: impact, assessment, and management	10
The safety of JAK kinase inhibitors for the treatment of myelofibrosis	10
Compared of efficacy and safety of high-dose donepezil vs standard-dose donepezil among elderly patients with Alzheimer’s disease: a systematic review and meta-analysis	10

Ayahuasca, a potentially rapid acting antidepressant: focus on safety and tolerability	10
Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: final results of a 3-year post-marketing surveillance study	10
A new look at the safety and tolerability of prostaglandin analogue eyedrops in glaucoma and ocular hypertension	9
Overview of checkpoint inhibitor pneumonitis: incidence and associated risk factors	9
Severe and persistent mental illness (SPMI) in pregnancy and breastfeeding: focus on second-generation long acting injectable antipsychotics	9
How can we manage the cardiac toxicity of immune checkpoint inhibitors?	9
Safety and tolerability evaluation of erenumab for the preventive treatment of migraine	9
Can ketamine be a safe option for treatment-resistant bipolar depression?	9
A review of hydroxyurea-related cutaneous adverse events	9
Association of H1-antihistamines with torsade de pointes: a pharmacovigilance study of the food and drug administration adverse event reporting system	9
Underreporting of Adverse Drug Events: a Look into the Extent, Causes, and Potential Solutions	9
Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1 (Oxford-AstraZeneca) and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines in the United Kingdom	9
Adverse drug reactions in elderly: a five-year review of spontaneous reports to the Portuguese pharmacovigilance system	9
Hallucinations and delusions associated with Parkinson’s disease psychosis: safety of current treatments and future directions	9
Hallucinogen persisting perceptual disorder: a scoping review covering frequency, risk factors, prevention, and treatment	9
Safety of topical interventions for the treatment of actinic keratosis	9
Cardiovascular risks associated with protease inhibitors for the treatment of HIV	8
Safety of intranasal corticosteroids for allergic rhinitis in children	8
Safety considerations when managing gastro-esophageal reflux disease in infants	8
An updated safety review of the drug treatments for idiopathic pulmonary fibrosis	8
Introducing sexual dysfunction in mental care	8
A safety review of approved intrathecal analgesics for chronic pain management	8
Trends and concerns of potentially inappropriate medication use in patients with cardiovascular diseases	8
A systematic review of digital technology and innovation and its potential to address anti-corruption, transparency, and accountability in the pharmaceutical supply chain	8
Association between cyclin-dependent kinase 4/6 inhibitors and venous thromboembolism: analysis of F.A.E.R.S. data	8
A reappraisal of the role of fever in the occurrence of neurological sequelae following lithium intoxication: a systematic review	8
Safety and benefit of incretin-based therapies in patients with type 2 diabetes: learnings and reflections	8
Safety considerations selecting antiseizure medications for the treatment of individuals with Dravet syndrome	8
Safety implications of combining ACE inhibitors with thiazides for the treatment of hypertensive patients	8
A new paradigm in adverse drug reaction reporting: consolidating the evidence for an intervention to improve reporting	8
Efficacy and safety of finerenone for treatment of diabetic kidney disease: current knowledge and future perspective	7
A safety review of biologic therapies for the management of hidradenitis suppurativa and unmet needs	7
A systematic review, meta-analysis and meta-regression evaluating the adverse reactions to erenumab in the preventive treatment of migraine	7
An update on the safety of insulin-GLP-1 receptor agonist combinations in type 2 diabetes mellitus	7
Novel uses of ketamine in the emergency department	7
Safety and efficacy review of aflibercept for the treatment of metastatic colorectal cancer	7
Resident and family engagement in medication management in aged care facilities: a systematic review	7
Hepatotoxicity of FDA-approved small molecule kinase inhibitors	7
Comparisons of adverse event reporting for colistin versus polymyxin B using the US Food and Drug Administration Adverse Event Reporting System (FAERS)	7
Safety review of current pharmacotherapies for levodopa-treated patients with Parkinson’s disease	7
Factors affecting persistence with biologic treatments in patients with rheumatoid arthritis: a systematic literature review	7
Safety of current treatments for paroxysmal nocturnal hemoglobinuria	7
Effect of drug interactions between carbapenems and valproate on serum valproate concentration: a systematic review and meta-analysis	7
A review of the evidence on the risk of congenital malformations and neurodevelopmental disorders in association with antiseizure medications during pregnancy	7
Cardiac adverse effects of antiseizure medications	7
An inter-professional student-run medication review programme. Reducing adverse drug reactions in a memory outpatient clinic: a controlled clinical trial	7
Combining two CGRP inhibitors to treat migraine	7
Icosapent ethyl: safely reducing cardiovascular risk in adults with elevated triglycerides	7
Risk factors for immune-mediated hepatotoxicity in patients with cancer treated with immune checkpoint inhibitors: a systematic review and meta-analysis	7
Pharmacovigilance approaches to study rare and very rare side-effects: the example of clozapine-related DiHS/DRESS syndrome	7
Improving the treatment of patients with diabetes using insulin analogues: current findings and future directions	7
Cardiac disorder-related adverse events for aryl hydrocarbon receptor agonists: a safety review	7
Effect of levosimendan on renal function in background of left ventricular dysfunction: a meta-analysis of randomized trials	7
Medication errors during a pandemic: what have we learnt?	7
Adverse events in long-term studies of exogenous melatonin	7
A review of potential neuropathological changes associated with ketamine	7
Serotonin 5-HT 2B receptor agonism and valvular heart disease: implications for the development of psilocybin and related agents	7
Effectiveness and sustainability of deprescribing for hospitalized older patients near end of life: a systematic review	7
The safety of oral antifungals for the treatment of onychomycosis	7
Lasmiditan for single migraine attack in Japanese patients with cardiovascular risk factors: subgroup analysis of a phase 2 randomized placebo-controlled trial	7
Regulatory experience of handling Risk Management Plans (RMPs) for medicinal products in the EU	7
Safety of treatment options available for postoperative pain	7
Defining and enhancing collaboration between community pharmacists and primary care providers to improve medication safety	7
Effect of Acetaminophen use during pregnancy on adverse pregnancy outcomes: a systematic review and meta-analysis	6
A comparative review of current topical antibiotics for impetigo	6
Liver tests abnormalities with licensed antiviral drugs for COVID-19: a narrative review	6
The safety of available treatment options for short bowel syndrome and unmet needs	6
Safety of treating acute liver injury and failure	6
An update on safety evaluation of immune-based combinations in patients with advanced renal cell carcinoma	6
Clinical profile of acute pancreatitis following treatment with protease inhibitors: a real-world analysis of post-marketing surveillance data	6
Ocular toxicities associated with antibody drug conjugates and immunotherapy in oncology: clinical presentation, pathogenesis, and management strategies	6
Key considerations for the use of ketamine and esketamine for the treatment of depression: focusing on administration, safety, and tolerability	6
Systemic quinolones and risk of retinal detachment I: analysis of data from the US FDA adverse event reporting system	6
High risks adverse events associated with trastuzumab emtansine and trastuzumab deruxtecan for the treatment of HER2-positive/mutated malignancies: a pharmacovigilance study based on the FAERS databas	6
Pregnancy-related adverse events associated with statins: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System (FAERS)	6
The Safety of Medications used to Treat Peripheral Neuropathic Pain, Part 2 (Opioids, Cannabinoids and Other Drugs): review of Double-Blind, Placebo-Controlled, Randomized Clinical Trials	6
Comparing the use of individual and composite terms to evaluate adverse drug event disproportionality: a focus on glucagon-like peptide-1 receptor agonists and diabetic retinopathy	6
Craving and addictive potential of esketamine as side effects?	6
An overview of methodological flaws of real-world studies investigating drug safety in the post-marketing setting	6
Phenytoin and damage to the cerebellum – a systematic review of published cases	6

Safety of secukinumab for the treatment of active ankylosing spondylitis	6
What is the risk of cardiovascular events in osteoporotic patients treated with romosozumab?	6
Anti-inflammatory strategies for atherosclerotic artery disease	6
Barriers and facilitators for systematically registering adverse drug reactions in electronic health records: a qualitative study with Dutch healthcare professionals	5
Ocular adverse events associated with BRAF and MEK inhibitor combination therapy: a pharmacovigilance disproportionality analysis of the FDA adverse event reporting system	5
Safety evaluation of ustekinumab for moderate-to-severe ulcerative colitis	5
Long-term safety and effectiveness of linagliptin as add-on therapy in Japanese patients with type 2 diabetes: final results of a 3-year post-marketing surveillance	5
Dropped head syndrome: a rare adverse drug reaction identified in the FDA adverse event reporting system and review of case reports in the literature	5
Bleeding in acute coronary syndrome: from definitions, incidence, and prognosis to prevention and management	5
Bosutinib – related pleural effusion in patients with chronic myeloid leukemia	5
Fatigue and its management in cancer patients undergoing VEGFR-TKI therapy	5
A safety evaluation of current medications for adult women with the polycystic ovarian syndrome not pursuing pregnancy	5
Assessment of suspected adverse drug reactions in elderly patients with diabetes mellitus based on a Portuguese spontaneous reporting database: analysis of reporting from 2008 to 2018	5
Safety of elobixibat and lubiprostone in Japanese patients with chronic constipation: a retrospective cohort study	5
New approaches to antipsychotic medication adherence – safety, tolerability and acceptability	5
Post-marketing safety surveillance of erenumab: new insight from Eudravigilance	5
Investigating the risk of deep vein thrombosis with JAK inhibitors: a disproportionality analysis using FDA Adverse Event Reporting System Database (FAERS)	5
A safety review of current monoclonal antibodies used to treat multiple sclerosis	5
Risk of pancreatitis and pancreatic carcinoma for anti-diabetic medications: findings from real-world safety data analysis and systematic review and meta-analysis of randomized controlled trials	5
Efficacy and safety evaluation of safinamide as an add-on treatment to levodopa for parkinson’s disease	5
Flu vaccination in multiple sclerosis patients: a monocentric prospective vaccine-vigilance study	5
Update on infective complications in patients treated with alemtuzumab for multiple sclerosis: review and meta-analysis of real-world and randomized studies	5
Associations between hyper-polypharmacy and potentially inappropriate prescribing with clinical and functional outcomes in older adults	5
Risks and benefits of current and novel drugs to treat agitation in Alzheimer’s disease	5
Safety evaluation of perampanel as monotherapy or first adjunctive therapy in patients with epilepsy	5
Drug induced stuttering: pharmacovigilance data	5
Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System	5
Comment about the safety of intravenous voriconazole formulated with sulfobutylether beta-cyclodextrin	5
Methods for the detection of adverse drug reactions in hospitalized children: a systematic review	5
Safety considerations of current drug treatment strategies for nosocomial pneumonia	5
Safety of non-hormonal medications for managing hot flashes	5
Improving the data quality of spontaneous ADR reports: a practical example from Malta	5
Effects of anti-diabetes medications on cardiovascular and kidney outcomes in Asian patients with type 2 diabetes: a rapid evidence assessment and narrative synthesis	5
Safety of current immune checkpoint inhibitors in non-small cell lung cancer	5
Current treatment options for secondary hyperparathyroidism in patients with stage 3 to 4 chronic kidney disease and vitamin D deficiency	5
Reporting, handling, and subjective importance of adverse drug reactions among general practitioners: an exploratory cross-sectional survey	5
Tirzepatide and glucagon-like peptide-1 receptor agonists: safety always comes first!	5
Safety and tolerability of sacubitril-valsartan: a systematic review and meta-analysis	5
The safety profile of denosumab in oncology beyond the safety of denosumab as an anti-osteoporotic agent: still more to learn	5
Assessing intravitreal anti-VEGF drug safety using real-world data: methodological challenges in observational research	5
Safety evaluation of current therapies for high-risk severely ill patients with carbapenem-resistant infections	4
Thromboembolism profiles associated with cyclin-dependent kinase 4/6 inhibitors: a real-world pharmacovigilance study and a systematic review	4
Patients’ and health-care professionals’ perspectives on adverse drug reaction burden attributed to the use of biological DMARDs: a qualitative study	4
Ibrutinib plus rituximab for the treatment of adult patients with Waldenström’s macroglobulinemia: a safety evaluation	4
Fluoroquinolones: old drugs, putative new toxicities	4
A pharmacovigilance study on drug-induced liver injury associated with antibody-drug conjugates (ADCs) based on the food and drug administration adverse event reporting system	4
A drug safety evaluation of enzalutamide to treat advanced prostate cancer	4
Identification of novel signal of Raynaud’s phenomenon with Calcitonin Gene-Related Peptide(CGRP) antagonists using data mining algorithms and network pharmacological approaches	4
Interstitial pneumonitis associated with EGFR/ ALK tyrosine kinase inhibitors used in non–small cell lung cancer: an observational, retrospective, pharmacovigilance study	4
Comparative safety review of recommended, first-line single-tablet regimens in patients with HIV	4
Improving drug safety with adverse event detection using natural language processing	4
Safety evaluation of emicizumab prophylaxis in individuals with haemophilia A	4
A real-world pharmacovigilance study of severe cutaneous adverse reactions associated with antiepileptic drug combination therapy: data mining of FDA adverse event reporting system	4
Malignant syndromes: current advances	4
Post-Marketing Safety Concerns with Upadacitinib: A Disproportionality Analysis of the FDA Adverse Event Reporting system	4
Do new drugs for diabetic macular edema offer a safer option?	4
An update on the safety of long-term vedolizumab use in inflammatory bowel disease	4
Safety profile of lasmiditan in patients with migraine in an Asian population	4
Tailored first-line biologic and targeted synthetic disease modifying anti-rheumatic drugs therapy in patients with rheumatoid arthritis: 2021 updated ITABIO statements	4
Cardiovascular safety of current and emerging drugs to treat anaemia in chronic kidney disease: a safety review	4
Post-marketing safety of anti-IL-5 monoclonal antibodies (mAbs): an analysis of the FDA Adverse Event Reporting System (FAERS)	4
Safety review of current systemic treatments for severe chronic rhinosinusitis with nasal polyps and future directions	4
Drug-induced Stevens-Johnson syndrome: a disproportionality analysis from the pharmacovigilance database of the World Health Organization	4
Comparative safety review of current pharmacological treatments for interstitial cystitis/ bladder pain syndrome	4
Safety evaluation of oliceridine for the management of postoperative moderate-to-severe acute pain	4
Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle – a focus on benefits and risks	4
Immune checkpoint inhibitors increase the risk of kidney transplant rejection: a real-world pharmacovigilance study	4
Interstitial lung disease and CDK4/6 inhibitors in the treatment of breast cancer	4
A novel approach for the treatment of hypertension with the soluble guanylate cyclase stimulating drug	4
Drug safety evaluation of ixekizumab for psoriasis: a review of the current knowledge	4
Comparative safety review of the current therapies for gastroenteropancreatic neuroendocrine tumors	4
Safety profile of clobazam in the real world: an analysis of FAERS database and systematic review of case reports	4
Directly acting antivirals are safe and effective in HCV positive patients aged 80 years and older: a multicenter real-life study	4
The safety profile of FLT3 inhibitors in the treatment of newly diagnosed or relapsed/refractory acute myeloid leukemia	3
Opioid-related adverse drug events in surgical patients: risk factors and association with clinical outcomes	3
A safety review of recently approved and emerging drugs for patients with relapsed or refractory multiple myeloma	3
A pharmacovigilance analysis of FDA adverse event reporting system events for romosozumab	3
Performance of subgrouped proportional reporting ratios in the US Food and Drug Administration (FDA) adverse event reporting system	3
Colistin-associated Stevens-Johnson syndrome and toxic epidermal necrolysis reactions: a retrospective case-non-case pharmacovigilance study	3
Proton pump inhibitors and increased reporting odds of renal neoplasms: FAERS-based adverse event data mining and analysis	3
Pre-therapeutic evaluation and practical management of cardiovascular and renal toxicities in patients with metastatic radioiodine-refractory thyroid cancer treated with lenvatinib	3
Safety and efficacy of anti-SARS-CoV-2 monoclonal antibodies in pregnancy	3
Safety and effectiveness of fifth generation cephalosporins for the treatment of methicillin-resistant staphylococcus aureus bloodstream infections: a narrative review exploring past, present, and fut	3
Seizures associated with antibiotics: a real-world disproportionality analysis of FAERS database	3
The efficacy and safety of Capivasertib (AZD5363) in the treatment of patients with solid tumor: a systematic review and meta-analysis of randomized clinical trials	3
Progressive multifocal leukoencephalopathy with natalizumab extended or standard interval dosing in the United States and the rest of the world	3
Safety of current antiviral drugs for chronic hepatitis B	3
Advocating a person-centered care approach to drug safety	3
Direct oral anticoagulants toxicity in children: an overview and practical guide	3
Safety evaluation of the DTaP5-IPV-Hib-HepB vaccine: a review	3
Urinary tract infections and genital mycotic infections associated with SGLT‑2 inhibitors: an analysis of the FDA Adverse Event Reporting System	3
The long-term safety of chronic azithromycin use in adult patients with cystic fibrosis, evaluating biomarkers for renal function, hepatic function and electrical properties of the heart	3
Cardiovascular toxicities following the use of tyrosine kinase inhibitors in hepatocellular cancer patients: a retrospective, pharmacovigilance study	3
A safety evaluation of ruxolitinib for the treatment of polycythemia vera	3
Safety of lenalidomide for maintenance treatment of patients with multiple myeloma following autologous stem cell transplantation	3