Current drug safety最新文献

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. 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 an 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.

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 ®. An attempt was made to refer to all English-language articles published between 2000 to 2020 using keywords like flavonoids potential in nephrotoxicity and nephrotoxicity treatment approaches with herbal remedies.

Conclusion: This comprehensive review delves into the molecular mechanisms underlying the reno-protective effects of flavonoids. By scavenging reactive oxygen species, inhibiting inflammatory mediators, and modulating intracellular signalling pathways, flavonoids can mitigate oxidative stress and inflammation, thereby preserving renal function and integrity. Preclinical studies have demonstrated the potential of specific flavonoids in ameliorating drug-induced nephrotoxicity, renal ischemia-reperfusion injury, diabetic nephropathy, and other kidney diseases. Furthermore, epidemiological evidence highlights the inverse relationship between flavonoid intake and the risk of developing kidney diseases. Nevertheless, understanding the molecular mechanisms of flavonoids in nephroprotection offers exciting prospects for developing novel therapeutic strategies to combat kidney diseases and promote kidney health.

Phenylalanine, an essential amino acid, is the "building block" of protein. It has a tremendous role in different aspects of metabolic events. The tyrosine pathway is the prime one and is typically used to degrade dietary phenylalanine. Phenylalanine exceeds its limit in bodily fluids and the brain when the enzyme, phenylalanine decarboxylase, phenylalanine transaminase, phenylalanine hydroxylase (PAH) or its cofactor tetrahydrobiopterin (BH4) is deficient causes phenylketonuria, schizophrenia, attentiondeficit/ hyperactivity disorder and another neuronal effect. Tyrosine, an amino acid necessary for synthesizing the pigments in melanin, is produced by its primary metabolic pathway. Deficiency/abnormality in metabolic enzymes responsible for the catabolism pathway of Phenylalanine causes an accumulation of the active intermediate metabolite, resulting in several abnormalities, such as developmental delay, tyrosinemias, alkaptonuria, albinism, hypotension and several other undesirable conditions. Dietary restriction of the amino acid(s) can be a therapeutic approach to avoid such undesirable conditions when the level of metabolic enzyme is unpredictable. After properly identifying the enzymatic level, specific pathophysiological conditions can be managed more efficiently.

Background: Pharmacovigilance (PV) deals with the detection, collection, assessment, understanding, and prevention of adverse effects associated with drugs. The objective of PV is to ensure the safety of the medicines and patients by monitoring and reporting all adverse drug reactions (ADRs) associated with prescribed medicine usage. Findings have indicated that about 0.2- 24% of hospitalization cases are due to ADRs, of which 3.7% of patients have lethal ADRs. The reasons include the number of prescribed drugs, an increased number of new medicines in the market, an inadequate PV system for ADR monitoring, and a need for more awareness and knowledge about ADR reporting. Severe ADRs lead to enhanced hospital stays, increased treatment costs, risk of death, and many medical and economic consequences. Therefore, ADR reporting at its first instance is essential to avoid further harmful effects of the prescribed drugs. In India, the rate of ADR reporting is less than 1%, whereas worldwide, it is 5% due to a need for more awareness about PV and ADR monitoring among healthcare providers and patients. The main objective of this review is to highlight the current scenario and possible futuristic ways of ADR reporting methods in rural areas of India. We have searched the literature using PubMed, Google scholar, Indian citation index to retrieve the resources related to ADR monitoring and reporting in India's urban and rural areas. Spontaneous reporting is the most commonly used PV method to report ADRs in India's urban and rural areas. Evidence revealed that no effective ADR reporting mechanisms developed in rural areas causing underreporting of ADR, thus increasing the threat to the rural population. Hence, PV and ADR reporting awareness among healthcare professionals and patients, telecommunication, telemedicine, use of social media and electronic medical records, and artificial intelligence are the potential approaches for prevention, monitoring, and reporting of ADRs in rural areas.

Introduction: Paracetamol (Acetaminophen) is a very common OTC drug that is found in more than 200 OTC products sold as pain, cough and cold remedies. Paracetamol is commonly used as an antipyretic to reduce fever and as an alternative to Non-steroidal anti-inflammatory drugs (NSAIDs) that are contraindicated in certain patients to relieve mild-moderate pain.

Objective: This review article focuses on SJS, TEN, SJS/TEN overlap, AGEP, and DRESS syndromes associated with the use of paracetamol or paracetamol-containing products.

Methods: To find published articles relevant to paracetamol-associated SJS, TEN, AGEP, and DRESS, we searched the online databases Medline/Pubmed/PMC, Google Scholar, Science Direct, Ebsco, Scopus, Web of Science, Embase, and reference lists using keywords like Stevens-Johnson Syndrome, Acetaminophen, Paracetamol, Toxic epidermal necrolysis, Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms.

Results: The paracetamol-associated SJS, TEN, SJS/TEN overlap, AGEP, and DRESS syndromes have been identified by a number of publications.

Conclusion: When evaluating drug-induced hypersensitivity skin reactions, healthcare professionals, including prescribers, pharmacists, and others, should be aware of this rare risk. Patients who exhibit signs and symptoms of paracetamol-associated hypersensitivity should be referred to physicians by pharmacists for further treatment. At the first sign of a skin rash or other hypersensitivity reaction while taking paracetamol, patients should be told to stop taking it and see a doctor right away.

Background: Phenylephrine is a sympathomimetic, which means it acts analogous to adrenaline. Phenylephrine can be taken orally to treat nasal congestion symptoms. It is also frequently mixed with other medicines in products meant to relieve cough and cold symptoms. Given the widespread usage of phenylephrine, related drug eruptions appear to be uncommon.

Case presentation: Here we discuss a case of a 19-year-old female patient who reported to our hospital with blebs on the skin throughout her legs and torso. The drug eruption or adverse drug response was linked with itching, had a slow beginning, and progressed. Her medical history indicated that she had been taking phenylephrine 10 mg orally twice a day. On the sixth day, she experienced an adverse medication response caused by the medicine phenylephrine. Phenylephrine was stopped immediately and the other medications, such as levocetirizine, montelukast, and nasal spray, were continued. The patient was told not to use phenylephrine, either alone or in combination with FDCs. There are no other complaints. As a result, the patient was diagnosed with phenylephrine- induced eruption.

Conclusion: We present this case to highlight the importance of inspiring a pharmacovigilance mindset among all clinicians providing care as a routine alert drug, phenylephrine-induced drug eruption.

Background: Survival in multiple myeloma (MM) has improved in the past years with the introduction of immunomodulators and proteasome inhibitors. However, chemotherapyinduced 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. Patients were interviewed using validated tools to measure CIPN and HRQoL, along with sociodemographic and clinical questions. Logistic regression was used to assess the association of CIPN with sociodemographic, clinical, and HRQoL variables.

Results: In total, 217 patients were eligible for the study. The median age was 67, 50.9% were women, 51.6% had low income, 47.5% had low education, and 55.3% attended private health services. The chemotherapy regimen most used was the combination of cyclophosphamide, thalidomide, and dexamethasone (17.5%) among the 24 types of regimens found. Most patients (90.3%) had at least one CIPN symptom: 62.7% were severe, and 51.62% were extremely bothered ADL. Numbness was the most common symptom (40.6%). CIPN was independently associated with education, hospitalization, chemotherapy, side effects, disease symptoms, and global health status in HRQoL.

Conclusion: MM patients showed a high frequency of CIPN, which affected ADL and impaired HRQoL. Early and accurate detection of CIPN and dose management in patients with thalidomide and bortezomib-based regimens should be performed to provide better treatment outcomes and avoid permanent disabilities.

Introduction: Health science students are prone to self-medication due to easy accessibility to medicines, background medical knowledge, and their ability to diagnose illnesses. The ongoing COVID-19 pandemic has further encouraged this practice due to the fear of contracting the virus by visiting healthcare establishments.

Objectives: This study was conducted to assess the perception and practices of self-medication among health science students during the background of the COVID-19 pandemic.

Methods: This cross-sectional study was conducted in July 2021 during the second wave of COVID-19. Data were collected using a Microsoft form circulated among students using WhatsApp or email.

Results: The mean age of the 350 participants was 20.8 ± 1.5 years. About 165(47.1%) participants had self-medicated over the past one year. The most common mode of self-medication was using previous consultation notes [121(73.3%)]. The most common reason for self-medication stated was the mild nature of the illness [131(79.4%)]. Fifteen (9.1%) participants reported changes in medication from one to another during self-medication. Sixteen (9.7%) participants increased drug dosage during self-medication. Sixteen (26.2%) out of 61 participants who self-medicated with antibiotics did not complete the course. Forty-six (27.9%) out of the 165 participants were not aware of the adverse effects of the drugs being self-medicated on most occasions. One hundred and sixty seven (47.7%) of the total participants did not feel that self-medication practices are harmful. Ninety-five (27.1%) felt that self-medication practices are acceptable during the COVID-19 pandemic. Eighty-six (90.5%) of them thought so to avoid getting COVID-19 infection by visiting healthcare establishments. In multivariable analysis, participants in the final year and those with chronic morbidities were associated with self-medication practices.

Conclusion: Self-medication practices were present among 47.1% of participants. More than onefourth of them were not aware of the side effects of self-medicated drugs on most occasions. About 47.7% participants felt that self-medication practices are not harmful and more than one-fourth of them felt that it was acceptable during the COVID-19 pandemic. Therefore, the students need to be made aware of the harmful consequences of self-medication.

Background: Vaccination against COVID-19 virus is the most valuable tool available for protection during the pandemic of coronavirus. The clinical manifestation post-vaccination is a barrier to vaccination for many people in Iraq and worldwide.

Objectives: The objective of this study is identifying various clinical manifestations occurring after receiving vaccines among individuals in Basrah Governorate. Moreover, we examine its association with respondents' demographics and the type of vaccine they received.

Methods: A cross-section study was conducted in Basrah, southern Iraq. Research data were collected through an online questionnaire. The data were analyzed using both descriptive and analytic statistical tools using the SPSS program.

Results: Most of the participants (86.68%) received the vaccine. The side effects were reported in 71.61% of vaccinated individuals. Fever and muscle pain were the two most experienced clinical manifestations, while lymph node enlargement and disturbances in taste and/or smell sensations were reported infrequently. Adverse effects were mostly reported with the Pfizer BioNTech vaccine receiver. Females and those in the younger age group also reported a significantly higher incidence of side effects.

Conclusion: Most adverse effects related to the COVID-19 vaccine were minor and could be tolerated without the need for hospital admission.

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. The computational assessment was conducted with the help of reporting odds ratio (ROR) and its 95% confidence interval (CI).

Results: Overall, 8181 ICSRs in EV and 15905 ICSRs from VigiAccess were retrieved for neurologic events, with at least one ICI as the suspected drug. The majority of the ICSRs were reported for nivolumab, pembrolizumab, and ipilimumab, whereas frequently reported events were neuropathy peripheral, myasthenia gravis, seizure, Guillain-Barre syndrome, paraesthesia, syncope, encephalopathy, somnolence. Under EV, 92% of ICSRs were reported as serious, 10% included fatal outcomes, and nearly 61% cited patient recovery. Atezolizumab (ROR 1.64, 95% CI 1.75- 1.52), cemiplimab (ROR 1.61, 95% CI 1.98-1.3), and nivolumab (ROR 1.38, 95% CI 1.44-1.31) had a considerable increase in the frequency of ICSR reporting. Cerebrovascular accident, posterior reversible encephalopathy syndrome, tremor, and somnolence were identified as potential signals.

Conclusion: ICIs were significantly associated with neurologic risks, which cannot be generalized. A considerable increase in ICSR reporting frequency was observed with atezolizumab, cemiplimab, and nivolumab, while avelumab, pembrolizumab, durvalumab, and cemiplimab were linked with four potential signals. These findings suggest the consideration of a revision of the neurologic safety profile of ICIs. Furthermore, the necessity for additional ad-hoc research is emphasized.