Current Drug Safety

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...

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). METHODOLOGY: 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...

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...

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...

No abstract text is available yet for this article.

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...

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...

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...

BACKGROUND: Survival in multiple myeloma (MM) has improved in the past years with the introduction of immunomodulators and proteasome inhibitors. However, chemotherapy-induced 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...

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 study 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...

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 pre-existing 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...

BACKGROUND: Over the past few years, major inspection findings have been identified in the "management of adverse reactions" that may be due to increasing workload in pharmaceutical organizations impacting the correctness of information in individual case safety reports (ICSRs). Although retrospective quality checks (Retro-QC) and late submission analyses are important steps in ensuring ICSR quality, their manual application poses several challenges that can be overcome through automation...

BACKGROUND: Prior research has suggested that buprenorphine-containing medications may be associated with an increased risk of dental disorders. However, published data describing adverse dental reactions in buprenorphine users by active ingredient composition and route of administration are limited. OBJECTIVE: The purpose of this study was to evaluate the influence of formulation on spontaneous reporting of dental disorders among patients treated with buprenorphine...

Epidemiologic studies on the risk of multiple sclerosis (MS) or demyelinating events associated with anti-tumor necrosis factor alpha (TNFαalpha;) use among patients with rheumatic diseases or inflammatory bowel diseases have shown conflicting results. Causal directed acyclic graphs (cDAGs) are useful tools for understanding the differing results and identifying the structure of potential contributing biases. Most of the available literature on cDAGs uses language that might be unfamiliar to clinicians...

BACKGROUND: Proton pump inhibitors (PPIs) are one of the most used classes of drugs. For most indications, PPIs are only recommended up to 8 weeks duration. However, PPI use continues to expand. Regular and prolonged use of PPIs should be avoided because of the risk of adverse events. OBJECTIVES: The main objective of this study was to (1) investigate the extent of PPI usage in people aged 65 or older in the province of British Columbia (BC), Canada, (2) provide an overview of the harms associated with the long-term use of PPIs...

No abstract text is available yet for this article.

INTRODUCTION: Spasticity is common sequelae of stroke, and often these patients receive anti-spastic drugs such as baclofen or tizanidine. Stroke patients have multiple co-morbidities such as hypertension, diabetes, and seizure. Tizanidine is an α2 and imidazole receptor agonist at a spinal and supraspinal level resulting in reduced central sympathetic outflow and causing hypotension rarely, especially in those receiving beta-blockers or angiotensin-converting enzyme inhibitors...

AIM: Pfizer/BioNTech (BNT162b2) is a COVID-19 vaccine with a reassuring safety profile. The main adverse reactions are mild local reactions. Cutaneous reactions are generally minor. The most common cutaneous reaction reported was a local injection-site reaction. CASE STUDY: Here we present 2 cases of erythema multiform (EM) following BNT162b2 vaccination with positive rechallenge. The 1st case was about a 51-year-old woman who developed 5 days after the 1st dose of the mRNA Pfizer/BioNTech (BNT162b2) a macular, erythematous, round-shaped lesions on the hands, knees and soles...

INTRODUCTION: Mercaptopurine, a thiopurine, is used in various disorders of immune regulation, such as autoimmune hepatitis. Thiopurine metabolism is complex with risk for overdosing, especially when metabolism is impaired by liver dysfunction. Hepatotoxicity may be due to mercaptopurine overdose and is often reversible after prompt cessation of the drug. CASE DESCRIPTION: Treatment of thiopurine toxicity is mainly supportive and literature on enhanced elimination by renal replacement therapy is ambiguous...

INTRODUCTION: The Coronavirus Disease 2019 (COVID-19) pandemic led to the fast development of vaccines, which is considered a medical advance in healthcare. With the extensive vaccination campaign performed worldwide, many adverse events following immunization (AEFI) were reported [1]. Most of them were flu-like symptoms, mild and self-limiting. However, serious adverse events, such as dermatomyositis (DM), an idiopathic autoimmune connective tissue disease, have also been reported. CASE PRESENTATION: In this report, we describe a case of skin erythema, edema, and diffuse myalgia attributed at first to Pfizer BioNTeh, COVID-19 vaccination, given the temporal relationship and the absence of significant medical history...