Current Drug Safety

BACKGROUND: Levetiracetam, a relatively recent addition to antiepileptic medications, is known for its broad-spectrum efficacy in treating partial and generalized tonic-clonic seizures in individuals of all age groups. Despite its favourable tolerability profile, rare instances of psychiatric side effects have been reported. This case study presents a rare occurrence of significant behavioural changes attributed to levetiracetam in a young female patient. CASE HISTORY: A 40-year-old woman with a long-standing history of epilepsy, well-managed with medication, presented with abrupt-onset behavioural changes, including irritability, aggression, crying spells, insomnia, increased talkativeness, and screaming...

INTRODUCTION: Prescribing cascade is a condition in which a drug administered to a patient causes an adverse reaction that is misinterpreted as a new condition, resulting in the addition of a new drug. CASE PRESENTATION: Here, we report the case of an elderly female patient who suffered from metabolic, neurologic, and urinary consequences of a prescribing cascade of antiemetic, antiepileptic, and dopaminergic drugs. While levosulpiride caused Parkinsonian symptoms, the dopaminergic drugs and valproate caused refractory hyponatremia followed by altered sensorium, and clidinium contributed to urinary retention...

INTRODUCTION: Hand-Foot Syndrome (HFS), also known as palmar-plantar erythrodysesthesia, is a common reaction to Tyrosine Kinase Inhibitors ( TKIs), which can often lead to discontinuation of the drug. Lenvatinib is a recently approved drug for the treatment of endometrial carcinoma, which has been proven to provide a better overall survival rate and longer duration of progression-free survival among patients with advanced endometrial cancer. Herein, we have reported a case of carcinoma endometrium with metastasis who had to discontinue the use of lenvatinib due to the adverse drug reaction...

BACKGROUND: Hyperprolactinemia is a commonly underestimated adverse effect of antipsychotic medications. There are still no consensus guidelines for the optimal monitoring and treatment strategies. OBJECTIVE: The aim of the study was to assess the monitoring and treatment practices of antipsychotic- induced hyperprolactinemia, in addition to the prevalence and risk factors associated with it. METHODS: A retrospective cohort observational study was conducted among patients attending the psychiatric clinics at an academic tertiary hospital in Riyadh, Saudi Arabia, from May 2020 until May 2021, by reviewing each patient's medical record for up to five years...

A drug called Xylazine has gained notoriety in recent times, earning the nickname "zombie drug" due to reported alarming effects on its users. Although Xylazine is primarily intended for veterinary use as a sedative and muscle relaxant for animals, there have been growing concerns about its misuse among humans, particularly in the context of illicit drug use. However, it is essential to rely on accurate and evidence-based information when discussing the health risks associated with any substance, rather than resorting to sensationalized terms like "zombie drug...

Bispecific antibodies (BsAbs) are promising immunotherapies for cancer treatment designed to engage both tumour and immune cells. However, their use is associated with potential toxicities, including cytokine release syndrome (CRS), neurotoxicity, and on-target, off-tumour toxicity. CRS, characterized by cytokine release, is the most common, potentially life-threatening toxicity. Neurotoxicity presents as neurological symptoms and on-target, off-tumour toxicity damages healthy cells. Incidence and severity vary based on BsAb type, dose, patient factors, and tumor characteristics...

BACKGROUND: There are concerns about indiscriminate prescriptions and the inappropriate use of proton pump inhibitors (PPIs) without any clear indications, especially among noncritically hospitalized patients. OBJECTIVE: This study aimed to characterize PPI prescriptions among non-critically hospitalized patients in a tertiary care hospital in Saudi Arabia. METHODS: A retrospective cross-sectional study was conducted at the King Abdulaziz University Hospital between June and August 2021...

UNLABELLED: In this review paper, we have analyzed the potential and issues associated with Pharmacovigilance (PV). The analysis is divided into four sections: background, stakeholders, data sources, and medicinal chemistry. Each section discusses the current state, the future trends, and the best practices of Pharmacovigilance (PV). The main purpose, methods, results, and implications of our analysis are summarized. BACKGROUND: Pharmacovigilance (PV) is the science and practice of monitoring, evaluating, understanding, and preventing adverse drug reactions...

BACKGROUND AND OBJECTIVE: Tramadol can inhibit serotonin and norepinephrine reuptake leading to stimulation of the central component of the hiccup reflex arc. We have found only two previous cases of tramadol-induced hiccups. Additionally, three pharmacovigilance studies have investigated the involvement of tramadol in cases who have developed hiccups as adverse effects. Herein, we have presented a case of a middle-aged male who has developed hiccups shortly after tramadol intake. CASE PRESENTATION: A 35-year-old male complaining of chronic pain in the right knee was treated with tramadol...

BACKGROUND: Most studies have focused on the impact of medication reconciliation on one of the points of hospital admission or discharge. In this study, we aimed to investigate the impact of medication reconciliation at both admission and discharge on medication safety in patients hospitalized with acute decompensated heart failure. METHODS: This was a prospective, single-center, cohort study conducted in a tertiary care cardiovascular hospital from October 2022 to March 2023 on patients hospitalized with acute decompensated heart failure...

AIMS & OBJECTIVES: The objective of this study was to conduct a systematic review of research pertaining to the COVID-19 vaccine and its association with neurological complications. METHOD: We performed a comprehensive search of the literature using Google Scholar, PubMed, and NCBI databases from December 2021 to December 2022. For Google Scholar, PubMed, and NCBI databases we used the following key search terms: "neurological adverse effects", "COVID-19 vaccination", "SARS-CoV-2", CNS complications, and CNS adverse effects...

BACKGROUND: We report a case of a 25-year-old female who presented with fever, rash and general malaise. CASE PRESENTATION: She was initially diagnosed and treated for peri-/myocarditis, but she deteriorated quickly with the development of extensive bilateral consolidations for which she was mechanically ventilated. Two weeks before admission, she took isotretinoin for less than a week for disfiguring acne. Diagnosis of drug-induced acute eosinophilic pneumoniae (EP) was made after excluding other causes of AEP...

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 who was treated with pyridostigmine, prednisolone, and AZA for 5 years. He presented with abdominal pain and increased fatiguability for 7 days...

BACKGROUND: Immune checkpoint inhibitors (ICIs) used in immunotherapy have revolutionized cancer management. However, ICI therapy can come with serious neurologic risks. OBJECTIVE: The objective of our study is to analyze the occurrence of neurologic events with ICIs. METHODS: We referred to EudraVigilance (EV) and VigiAccess to evaluate the frequency of individual case safety reports (ICSRs), including neurologic events with ICIs. Data was gathered for a period from the date of ICI's marketing authorization till 30 January 2023...

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...

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. METHOD: 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...

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...

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...

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...

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 ®...