Current Drug Safety - Current Issue

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 Aloe vera. A comprehensive literature search was conducted to gather relevant information from various biomedical databases. The chemical composition, mechanism of action, and therapeutic activities of Aloe vera 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. Aloe vera 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 Aloe vera as a therapeutic agent.

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.

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.

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.

Background: Atorvastatin and other statins belong to a category of cholesterollowering drugs, which may cause some damage to pancreatic cells despite their effectiveness. Aims: The present study investigated the effects of melatonin against atorvastatin-induced toxicity on islets of Langerhans and CRI-D2 cells. Methods: The MTT assay was used to determine cell viability. The effect of various concentrations of melatonin (0,10, 50, 100, 250, 500 and 1000 μM) on CRI-D2 cell viability was evaluated for 24 hours to determine the non-cytotoxic concentrations of melatonin. Additionally, cells were treated with different concentrations of atorvastatin (10, 100, and 150 ng/mL) for 24 hours to determine a concentration that could induce the maximum cell death. After selecting the appropriate concentrations for melatonin, cells were treated with atorvastatin (10, 100, and 150 ng/ml) and melatonin (10 and 100 μM) simultaneously for a period of 24 hours. Malondialdehyde (MDA), reactive oxygen species (ROS), superoxide dismutase, catalase, and glutathione peroxidase activity were assessed as indicators of oxidative stress. To assess mitochondrial function, the ratio of adenosine diphosphate (ADP) to adenosine triphosphate (ATP) and mitochondrial membrane potential (MMP) were measured. Results: Atorvastatin markedly raised ROS and MDA levels. This result was associated with a decrease in MMP, an increase in the ADP/ATP ratio, and a change in the activity of antioxidant enzymes. Atorvastatin (150 ng/mL)-induced mitochondrial damage was alleviated by concurrent melatonin and atorvastatin therapy. Conclusion: These results suggest that melatonin has a protective effect against atorvastatininduced toxicity in the mitochondria of pancreatic cells.

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 1^st 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, roundshaped lesions on the hands, knees and soles. She experienced a positive rechallenge one month later. In the 2^nd case, a 55-year-old man presented 6 days following the 2^nd shot of the mRNA Pfizer/ BioNTech (BNT162b2), targetoid eruption on the upper and lower members. The patient reported that he had the same skin lesions in ankles and soles few days following the 1^st shot of the same vaccine. Conclusion: Few cases of EM following COVID-19 vaccination were reported in the literature and positive rechallenge in only one case. Rechallenge was not performed in most cases. Our two cases are particular because of the positive rechallenge in both patients. This is the gold standard to confirm that the vaccine was the culprit agent in inducing EM.

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.

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.

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.

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.

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.