Current drug safety最新文献

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.

Results: Among the 662 patients, 35 patients (5.3%) and 242 patients (36.6%) had their serum prolactin levels monitored (at baseline and at follow-up, respectively). The prevalence of hyperprolactinemia was observed in 212 patients (32%). Only 76 patients (36%) were symptomatic. Female gender, younger age, and bipolar disorder had a significantly higher risk of developing hyperprolactinemia. 60% of the confirmed cases received treatment, of which 76 (60%) were adherent to treatment guidelines. The most common treatment strategies implemented were dose reduction (42.5%) and aripiprazole augmentation (29.1%).

Conclusion: It is imperative to conduct a baseline check of prolactin levels before commencing any antipsychotic therapy. Similarly, routine prolactin level monitoring is recommended regardless of symptoms in patients treated with antipsychotics with a possible prolactin-raising effect. Adherence to evidence-based treatment guidelines can improve patient quality of life and therapeutic compliance.

Introduction: With the increasing use of traditional medicine, there is a need to be vigilant in identifying and reporting adverse reactions associated with them. Punarnava Mandura is a commonly used Ayurvedic medicine for the treatment of anemia. It is well tolerated by the patients. To our knowledge, allergic reactions to Punarnava Mandura have not been reported in the literature. We reported a case of adverse cutaneous reaction, which was probably associated with Purnarnava Mandura.

Case presentation: A 60-year-old female patient developed skin rashes over her neck region after taking Punarnava Mandura and other drugs for osteoarthritis. She recovered upon withdrawal of all the medicines and treatment with anti-allergic drugs. The patient re-initiated treatment for joint pain except for Punarnava Mandura and completed the course without a recurrence of the event making the Punarnava Mandura the culprit drug.

Conclusion: Punarnava Mandura may cause allergic reactions, and clinicians should keep such adverse reactions in mind when using traditional medicine and report them to increase the scientific literature in this area.

Background: For surgical procedures of the upper limbs, ultrasound-guided supraclavicular brachial plexus block (SCBPB) represents a safe substitute for general anesthesia. The present study evaluated the effectiveness and safety of incorporating 1μg/kg dexmedetomidine (DEX) into 20 ml bupivacaine, as opposed to using 20 ml and 30 ml bupivacaine without additives, in SCBPB.

Methods: This randomized, controlled, double-blind study included 75 patients assigned to elective upper-limb surgery under the mid-humerus level. Patients were randomized into three equal groups to receive US-guided SCBPB with 20 ml bupivacaine 0.5% + 1 μg/kg DEX in group BD, 20 ml bupivacaine 0.5% without additives in group B20, and 30 ml bupivacaine 0.5% in group B30 (control).

Results: Compared to group B20, groups BD and B30 had significantly quicker onset times for sensory and motor blocks. Groups BD and B30 had a more significant block duration than group B20. Group BD experienced considerably lower intraoperative hemodynamics than groups B20 and B30. Groups BD and B30 had a significantly delayed time to first rescue analgesia and consumed less pethidine than group B20. Compared to group B20, the pain score was significantly reduced in groups BD and B30. Comparable levels of pain score, rescue analgesia time, total pethidine consumption, and motor and sensory block onset and duration were seen in the BD and B30 groups.

Conclusion: DEX with a lower volume (20 ml) of bupivacaine reaches the same result as a higher volume of bupivacaine (30 ml) in managing perioperative pain and hemodynamic stability without the risk of the high volume of bupivacaine. Further, adding DEX to small dose of bupivacaine (20 ml) is more effective than small dose of bupivacaine (20 ml) alone without additives in prolonging the duration of sensory and motor block, reducing pain intensity, and delaying the need for rescue analgesia.

Pharmacovigilance is an important subject in medicine and healthcare, which aims to prevent side effects and other drug-related problems by identifying, evaluating, understanding, and avoiding them. Its main objectives are ensuring that a drug's benefits balance its hazards and improving patient safety. Within medicine and healthcare, pharmacovigilance is an essential subject that focuses on identifying, evaluating, comprehending, and preventing side effects or any other issues associated with drugs. Its main objective is to improve patient safety and ensure a drug's advantages exceed its drawbacks. Pharmacovigilance has evolved significantly as a result of technological advancements, enabling more efficient medication, safety monitoring, and management. The combination of machine learning (ML) with artificial intelligence (AI) for data analysis, adverse reaction prediction, and signal detection, electronic health records (EHRs), and mobile health (mHealth) applications have enhanced real-time data collecting and expedited the reporting of adverse drug reactions (ADRs). Pharmacovigilance plays an important role which focuses on detecting, assessing, comprehending, and averting adverse medication reactions. Making sure a drug's advantages outweigh its disadvantages is its main objective to improve patient safety. Pharmacovigilance, which balances patient safety, efficacy, and regulatory compliance in clinical trials, is necessary to promote the safe and effective use of drugs.

Opioid Use Disorder (OUD) is defined by the persistent use of opioids despite adverse consequences. It is associated with increased mortality and a variety of mental and general medical comorbidities. Risk factors include younger age, male sex, lower educational attainment, lower income, and psychiatric disorders, such as other substance use disorders and mood disorders. Genetics also play a role in susceptibility to opioid use disorders. Long-term selfefficacy in opioid use for non-medical purposes suggests irreversible opioid use disorders. To evaluate the current understanding of opioid use disorders, the limitations in existing treatment approaches were examined, and strategies to improve outcomes through expanded treatment access and personalized care interventions were identified. An analysis was carried out regarding the role of existing pharmacological treatments, barriers within the care cascade, and potential advancements in healthcare delivery and innovation was carried out to address opioid use disorders. A comprehensive review of the literature was conducted by searching electronic databases (e.g., PubMed, Scopus) for articles published over the past 20-25 years. Relevant studies were selected based on predefined inclusion criteria, focusing on OUD risk factors, pharmacological treatments, barriers in the care cascade, and strategies for improving care. The selection process prioritized systematic reviews, clinical trials, and key guidelines. Although medications for opioid use disorders are effective, their impact is hindered by systemic issues at multiple levels of care. Addressing these challenges requires comprehensive efforts, including professional training, innovative treatments, and healthcare reforms to expand access and personalize care.

This extensive review delves into the complex relationship between prolonged use of metformin and the possible emergence of vitamin B12 deficiency (VB12D) in diabetic patients. Metformin, a pivotal element in diabetes management, is constantly linked with decreased absorption of vitamin B12, prompting concerns about the enduring consequences of this interaction. The review systematically amalgamates current evidence, elucidating the prevalence, mechanisms, and clinical ramifications of VB12D induced by consistent consumption of metformin. Exploring the different pathways through which metformin might disrupt the absorption of Vitamin B12, the review encompasses interference with the calcium-dependent membrane activity and alterations of the microbiota present in the gut. A meticulous analysis of experimental studies and human trials is undertaken, accentuating the prevalence of variable VB12D among individuals on long-duration treatment of metformin across diverse populations and age groups. Clinical indications of cobalamin deficiency, spanning haematological abnormalities to neurological complications, are systematically examined. Furthermore, the review delves into the potential implications of cobalamin deficiency associated with metformin on diabetes-related complications and overall patient health. This review offers a comprehensive overview of the intricate interplay between the use of metformin and deficiency of vitamin B12 in diabetic patients, emphasizing the importance that lies in routine monitoring, early detection, and personalized interventions to optimize the long-period safety and efficiency of metformin in the treatment of diabetes. It also proposes future research directions to refine clinical guidelines and enhance the understanding regarding the correlation between diabetes, metformin, and vitamin B12.

Background: Non-small Cell Lung Cancer (NSCLC) makes up about 85% of lung cancer cases, mainly adenocarcinoma and squamous cell carcinoma. Recently, PD-1 inhibitors have become crucial in NSCLC treatment, significantly enhancing survival for some. However, side effects, like skin reactions and hematotoxicity, limit their use, with drug-induced TEN and immunotherapy-induced agranulocytosis as severe adverse effects.

Case presentation: Herein, we have reported the case of a 75-year-old male diagnosed with metastatic Lung Squamous cell Carcinoma (LUSC) in the left lung. He received first-line treatment with one cycle of tislelizumab in combination with nab-paclitaxel and carboplatin, after which he developed Toxic Epidermal Necrolysis (TEN) and granulocytopenia. To address these two serious immune-related Adverse Events (irAEs), the patient was administered methylprednisolone in combination with gamma globulin for TEN and dexamethasone in combination with G-CSF for agranulocytosis. Antibiotics were also administered according to the patient's medication regimen. After treatment, the patient recovered and was discharged from the hospital. It was also noted that the lung tumor condition improved.

Conclusion: Effective management of severe immune-related side effects from tislelizumab, including TEN and agranulocytosis, can be partly achieved through steroids, gamma globulin, GCSF, and antibiotics. This strategy not only alleviates these adverse effects, but also potentially improves tumor conditions, highlighting the crucial role of vigilant monitoring and management in immunotherapy.

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 PV. The main purpose, methods, results, and implications of our analysis are summarized.

Background: PV is the science and practice of monitoring, evaluating, understanding, and preventing adverse drug reactions. PV was established by the World Health Organization in response to the thalidomide tragedy of 1961. The main purpose of PV is to ensure the safety and efficacy of drugs in clinical practice. Stakeholders: PV involves various stakeholders, such as patients, pharmacists, pharmaceutical companies, healthcare professionals, and regulatory authorities. Each stakeholder has a different role and responsibility in reporting, processing, analyzing, and communicating information about adverse drug reactions. Patient engagement is a key factor for enhancing PV practices.

Data sources: PV relies on data from various sources, such as clinical trials, spontaneous reports, electronic medical records, biomedical literature, and patient-reported data in online health forums. These data sources can provide valuable insights into the real-world use and safety of drugs, as well as the preferences and needs of patients. However, these data sources also pose challenges in terms of quality, validity, reliability, and accessibility. Medicinal Chemistry: Medicinal chemistry is the branch of chemistry that deals with the design, synthesis, and evaluation of new drugs and their biological effects. Medicinal chemistry can enhance PV practices by finding new therapeutic indications for existing drugs or compounds that have already been tested for safety and efficacy. Medicinal chemistry also requires careful design and evaluation of covalent inhibitors, bi-substrate inhibitors, stabilizers of protein non-effective conformations, and hydrophobic pocket modifiers to ensure their safety and efficacy.

Implications: PV is a dynamic and evolving discipline that requires collaboration, regulation, education, and innovation to improve patient safety and care. This review aims to provide a comprehensive overview of the potential and issues associated with PV practices.

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.