Naranjo Scale Research Articles

Adverse drug reaction due to combination of gabapentin and nortriptyline along with its causality assessment

The combination of gabapentin and nortriptyline is used as the first line drug treatment for management of neuropathic pain; however adverse drug reactions (ADRs) are one of the main causes for discontinuation of the therapy. This is a case study of erythematous maculopapular rash induced by combination of gabapentin and nortriptyline along with its causality assessment. A 55-year-old female came with complaint of back pain for 1 month. She was diagnosed as a case of L1 acute osteoporotic disc compression fracture. The patient was then administered combination tablet of gabapentin and nortriptyline (100 mg/10 mg) orally for the neuropathic pain. After 3 days she developed erythematous maculopapular rash on face, upper limbs and back. Following this the drug was then discontinued and pheniramine, hydrocortisone and combination tablet of levocetirizine and montelukast was administered to treat the rashes. Causality assessment was done using the Naranjo scale and WHO UMC assessment scale. The ADRs was reported by VigiFlow in the pharmacovigilance centre. Causality assessment using Naranjo scale (Score 6) and WHO UMC scale indicates probable relationship. Hence, monitoring is essential for any ADRs while using combination of gabapentin and nortriptyline therapy. In case of ADRs, discontinue the therapy and report the adverse drug reactions to pharmacovigilance centre.

Clinical Pattern and Causality Assessment of Drug-induced Cutaneous Reactions in a Tertiary Care Hospital in India: A Prospective Study.

Cutaneous Adverse Drug Reactions (ADRs) are common and pose a serious challenge to physicians, especially in cases when the patient has many comorbidities, is polypharmacy, or self-administers over-the-counter medications. The objective of this study is to analyze the clinical pattern and incidence of cutaneous ADRs and perform causality assessment using the WHO-UMC scale and Naranjo's scale. The severity of the reactions was determined by the Hartwig scale. This was conducted as a prospective observational study in patients admitted to SRM Medical College, Kattankulathur, Tamil Nadu, India, between November 2016 to August 2018 after obtaining Institutional Ethics Committee clearance of all adverse drug reactions reported at the hospital. Of the 158 ADRs reported during the time period, 101 were cutaneous ADRs, of which the most common presentation was maculopapular rash (n=42; 41.58%). The most common drugs which produced cutaneous adverse reactions were antimicrobials (n=58; 57.42%) followed by NSAIDs (n=35; 34.6%). The causality assessment as per the Naranjo scale yielded 3.96% (4) cases as definite, 81.18% (82) as probable, and 14.85% (15) as possible, whereas the WHO scale yielded 9 (89.10%) certain, 64 (63.36%) probable and 28 (27.72%) possible cases. The severity of the cases determined as per the Hartwig scale yielded 82.17% cases as mild and 17.82% as moderate. It is important to recognise the ADRs at the right time and exert caution in future use. This can minimise harm to the patient both physically and financially and improve the outcome of the treatment.

A CASE REPORT ON N-ACETYLCYSTEINE (MUCINAC) INDUCED CHEST TIGHTNESS

N-Acetylcysteine is anapproved drug by the Food and Drug Administration (FDA) and recognized by the World Health Organization (WHO) as an essential drug[1]. It isa synthetic N-acetyl derivative and prodrug of the endogenous amino acid L-cysteine, a precursor of the antioxidant glutathione (GSH), with mucolytic, antioxidant, and anti-inflammatory activities[4]. Primarily approved for the treatment of potentially hepatotoxic doses of acetaminophen. It is also used in the treatment of respiratory disorders, especially in COPD and cystic fibrosis[6]. An unusual case of chest tightness due to mucinac (N-Acetylcysteine) was reported in a female patientwith a history of cancer in the left upper alveoluswas admitted to the hospital for radiotherapy + chemotherapy. She was prescribed tablet mucinac for excessive mucus and to improve respiratory symptoms. The patient developed chest tightness after ingestion of mucinactablets.According to the Naranjo scale the observed reaction was a probable ADR.Later tablet was stopped, replaced nebulization with budecort respule. Keywords: N-acetylcysteine, glutathione, antioxidant, anti-inflammatory, mucolytic, COPD, Cystic fibrosis, Chest tightness

In vitro basophil activation test for drug hypersensitivity diagnosis

According to the definition of the World Health Organization, drug allergy is one of the types of adverse reactions to drugs, and is defined as any harmful or unintended reaction that occurs in doses used for prevention, diagnosis or treatment (Astakhova A. V., 2008). In accordance with the studies data, patients with an adverse drug reaction (ADR) account for approximately 6.5 % of all hospitalizations, and the incidence of fatal ADRs is 0.32 %. This explains why drug allergy is an important clinical problem (Kostyleva M. N., 2014, Verlan N. V., Rybalko M. V., 2013). Purpose of the study: to conduct a CAST (drug intolerance test) in children with a positive result on the Naranjo scale.

Cutaneous adverse drug reactions among people living with human immunodeficiency virus in a tertiary care hospital in Johor, Malaysia.

Cutaneous adverse drug reactions (cADRs) among people living with HIV (PLWH) are common. Data on drug eruptions among PLWH in Malaysia are limited. Thus, our study aimed to determine the clinical patterns of cADRs among PLWH and the risk factors associated with severe cutaneous adverse reactions (SCAR). A cross-sectional study was conducted among PLWH who developed cADRs presenting to our dermatology clinic from June 2020 to December 2020. The Naranjo scale was used for drug causality assessment. A total of 78 PLWH were recruited with a male-to-female ratio of 12:1. The maculopapular eruption was the commonest type of cADRs (75.6%), followed by drug reaction with eosinophilia and systemic symptoms (DRESS) (15.4%). SCAR is defined as a potentially life-threatening, immunologically mediated, drug-induced disease, accounting for 17.9% of the cases. Most of the patients were on antiretroviral therapy (ART) (85.9%), with efavirenz + tenofovir/emtricitabine being the most common combination (80.6%). Efavirenz (51.3%) was the main culprit drug implicated, followed by trimethoprim/sulfamethoxazole (23.1%) and nevirapine (11.5%). CD4 T-cell count <100 cells/μL (p = 0.006) was the independent risk factor for SCAR. Most cases had probable causal relationships with the culprit drugs (84.6%) and were not preventable (93.6%). The commonest cADR seen in PLWH was maculopapular eruption, while efavirenz, trimethoprim/sulfamethoxazole, and nevirapine were the three main implicated drugs. Most of the cases had probable drug causality and were not preventable. PLWH with CD4 count <100 cells/μL were particularly at risk of developing SCAR. Overall, this study showed that immune suppression and polypharmacy as a consequence of opportunistic infection prophylaxis are important factors contributing to the increased risk of ADRs among PLWH.

A A Rare Case Report of Toxic Epidermal Necrolysis with Iron Sucrose/first line Anti-tuberculosis Treatment Drugs

Toxic Epidermal Necrolysis [TEN] is life-threatening condition with mortality rate of 30-60%. Most common etiology of TEN is drug induced. Though Anaphylactic [Type I Hypersensitivity] reactions have been reported with Iron Sucrose, we present first case of TEN [Type IV Hypersensitivity], associated with Iron Sucrose along with Anti-tuberculosis treatment [ATT], to our knowledge. Iron Sucrose is considered relatively safer than other iron formulations. After 48 hours of administering Intravenous Iron Sucrose [20 mg in 200 ml N.S] infusion [first day], patient developed TEN symptoms [third day]. He was taking first line ATT drugs since past one month for Pulmonary Tuberculosis. On basis of history, 80-90% Body Surface area involvement, positive Nikolsky sign and laboratory findings, patient was diagnosed with drug induced TEN [fifth day]. For TEN management, ATT was withdrawn and patient was treated with intravenous Dexamethasone, Piperacillin/Tazobactam, Metronidazole, Pantoprazole, Intravenous fluids with dermatologically supportive local applications and patient was monitored. Patient died due to septic shock despite all resuscitative measures [seventh day]. Causality assessment (WHO UMC scale and Naranjo scale) was ‘Possible’ for both Iron Sucrose and ATT drugs. No improvement in patient’s condition after withholding ATT and short duration between Iron sucrose and symptoms of TEN onset suggests an increased likelihood of TEN induction by Iron sucrose. However, either ATT or Iron Sucrose could trigger TEN in presence of other drug. Improved understanding by physicians of these relatively unknown life-threatening ADR’s and interactions can aid in early identification and enhanced vigilance in future scenarios.&#x0D; Keywords: WHO UMC Scale, SCORTEN score, Naranjo scale, Anaphylactic reactions

Characteristics and Management of Granulomatous Lobular Mastitis Associated with Antipsychotics-Induced Hyperprolactinemia.

Background: Granulomatous lobular mastitis (GM) is a rare inflammatory breast disease. Reports focusing on GM caused by antipsychotic-induced hyperprolactinemia (HPRL) are very rare. Aim: To report a study of GM associated with antipsychotic-induced HPRL and discuss the mechanism and management. Materials and Methods: A retrospective review of patients with GM and psychiatric disorders were carried out. The clinical characteristics, management and outcome were collected and analyzed. The relationship between antipsychotics and GM was evaluated using the Naranjo Adverse Drug Reaction Probability Scale (Naranjo scale). Results: Nineteen female GM patients with psychiatric diseases, aged 21-39 years, who had received antipsychotics for 0.5-10.2 years were included. Most patients took multiple antipsychotics, and 10 (52.6%) took risperidone-containing regimens. Increased prolactin (PRL) was detected in all patients (range 35.15-200 ng/mL). The scores of Naranjo scale were 7-8, indicated the antipsychotics probably induced GM. All patients received systemic therapy, and were prescribed bromocriptine. Seven patients (36.8%) decreased the dose of antipsychotics, six (31.6%) switched antipsychotics, three (15.8%) continued the primary antipsychotics, and three (15.8%) discontinued antipsychotics. In addition, 14 patients (73.7%) received corticosteroid, 4 (21.1%) received antimycobacterials. PRL decreased to normal in 1 month. Seven patients (36.8%) received excisional surgery. After 12 months' follow-up (range 9-56 months), only three patients (15.8%) had a recurrence. Conclusion: Long-term use of antipsychotics may increase PRL levels, and lead to GM. It is vital to assess PRL level and reduce PRL to normal in patients with GM.

Prevalence of adverse reactions to intravenously administered originator biologics in patients with rheumatoid arthritis: A 5-year retrospective study

BackgroundFew Saudi studies have examined adverse drug reactions (ADRs) in patients with rheumatoid arthritis (RA) receiving intravenous (IV) originator biologics. Therefore, this study aimed to evaluate the prevalence, types, and predictors of ADRs following long-term IV originator biologic use in patients with RA. Patients and methodsThis retrospective, single-center study included adult patients with RA who received IV originator biologics between 2015 and 2020. Medical records were reviewed and data regarding ADRs were collected and evaluated for causality using the Naranjo scale. Binary logistic regression analysis was performed to identify the odds for and factors associated with developing ADRs for each biologic. ResultsA total of 129 patients (87.6% women) with a mean (standard deviation) age of 54 (13) years were included in this study. A total of 1963 doses of tocilizumab (38.76%), rituximab (38.76%), abatacept (13.95%), and infliximab (8.53%), were administered during the study period. ADRs with a Naranjo score ≥ 1 were experienced by 103 (78%) patients, with an average of 2.2 events per patient. Infection (26.6%) and skin and mucous membrane disorders (14.18%) were the most commonly reported ADRs. Abatacept was associated with a significantly higher risk of multiple ADRs than the other biologics (adjusted odds ratio: 3.145, 95% confidence interval 1.004–9.854, p = 0.049). ConclusionThere was a high prevalence of ADRs among patients with RA receiving biologics. Abatacept was associated with a greater risk of multiple ADRs than other biologics. Infection was the most common ADR. Future multicenter longitudinal studies are warranted.

ALLOPURINOL INDUCED ADVERSE DRUG REACTIONS: CASE SERIES

Allopurinol is widely used drug for patients of hyperuricemia and gout. The few adverse drug reactions related to allopurinol are diarrhea, fever, hepatotoxicity, Steven Johnson Syndrome- Toxic Epidermal Necrolysis (SJS-TEN), congestive heart failure and renal failure. In this article we have described eleven cases to evaluate the causality, cause and management of this syndrome. In this study eleven retrospective cases were selected from the ADR reports. The full details of the cases were collected from Christian Medical College from the period of 2012 to 2016. Causality was established using Naranjo scale and classication was done based on severity and resolution of ADR. It was observed that cases presented with mild to severe reactions of allopurinol, which is the suspected offending agent. Cases were resolved with supportive treatment while ve case had a prolong hospitalization and two cases had a life threatening drug reaction. Early detection and management of this severe form of systemic reaction is very important for better will be the prognosis.

Dipeptidyl peptidase-4 inhibitor-associated cutaneous eruptions: a retrospective observational study.

Dipeptidyl peptidase (DPP)-4 plays a complex role in immune regulation and its inhibition can have effects on the pathogenesis of various skin diseases. Studies have shown that DPP-4 inhibitors are associated with an increased risk of bullous pemphigoid (BP). To analyse the clinical and histopathological features of cutaneous adverse events in patients on DPP-4 inhibitors. We performed a retrospective review of patients with suspected DPP-4 inhibitor-associated cutaneous adverse events, at a tertiary teaching hospital from 1 January 2017 to 31 December 2020. Exclusion criteria included previous history of chronic skin disease and lack of histopathological reports or follow-up records. The clinical characteristics, latency period, Naranjo Adverse Drug Reaction Probability Scale and clinical outcomes were evaluated. In total, 18 patients (10 men, 8 women; mean age 68.6 years, range 38-89 years) were included. The DPP-4 inhibitors used were teneligliptin (n = 6), vildagliptin (n = 6), sitagliptin (n = 4), linagliptin (n = 1) and saxagliptin (n = 1). The mean interval between therapy initiation and lesion onset was 8.8 months (range 1-24 months). The dermatoses noted were BP (n = 12; 66.6%), lichenoid dermatitis (n = 4; 22.2%), psoriasiform dermatitis (n = 1; 5.6%) and spongiotic dermatitis (n = 1; 5.6%). Eight patients (44.4%) had necrotic keratinocytes as one of the distinct histological features. Causality assessment using the Naranjo scale rated the causative role of DPP-4 inhibitors as 'possible' in all patients. Of the 18 patients, 11 (61.1%) noted improvement in their condition following discontinuation of DPP-4 inhibitors, with 5 having complete remission within 6 months of stopping the drug. DPP-4 inhibitor-associated dermatoses are not necessarily limited to BP. It is necessary to recognize the possibility of other dermatoses in patients on DPP-4 inhibitors as drug substitution/cessation may improve disease morbidity.

Fluconazole-Induced adrenal insufficiency following allogeneic hematopoietic cell transplant

Adrenal insufficiency (AI) is a potentially life-threatening endocrine abnormality rarely associated with azole antifungals. Patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) are at high risk of invasive fungal infection and frequently receive azoles. Signs and symptoms of AI, such as gastrointestinal symptoms, lethargy, and electrolyte disturbances frequently overlap with common alloHCT toxicities, such that azole-induced AI may be under-reported in this population. We report the first published case of azole-induced AI following alloHCT. The patient presented with orthostasis and nonspecific gastrointestinal and failure to thrive symptoms in the setting of roughly 6 weeks of fluconazole prophylaxis. The patient was found to have primary AI diagnosed via low serum cortisol and inadequate response to cosyntropin. AI symptoms resolved with hydrocortisone supplementation and recurred upon rechallenge with fluconazole. The patient had fluconazole permanently discontinued with resolution of symptoms. We rate this case as a probable adverse drug reaction on the Naranjo scale. AI may be underreported and misdiagnosed in the alloHCT population given the presence of multiple toxicities with overlapping features. Clinicians must be diligent in investigating adrenal function in patients undergoing alloHCT on azole antifungals who present with symptoms of AI.

Management of Medication-Induced Psychiatric Disorders.

Management of Medication-Induced Psychiatric Disorders.

Thrombocytopenia Associated With Teicoplanin Use: A Retrospective Observational Study.

Contradictory studies reporting vast heterogeneity in the teicoplanin-induced thrombocytopenia (TIT) incidence exist. To identify the incidence of TIT associated with teicoplanin dosing range (6-12 mg/kg/dose) and the risk factors of TIT. This retrospective observational study included adult patients who received teicoplanin for ≥3 consecutive days over a period of 3.5 years. Thrombocytopenia was defined as a platelet count of <100 × 103/µL coupled with at least a 25% drop from the baseline count. The TIT incidence was assessed using the adverse drug reaction probability scale (Naranjo scale). Data from 482 patients who received teicoplanin and met the predefined inclusion criteria were included in the analyses. The cohort presented a mean age of 53.5 ± 19 years, where 72.4% were male, and 49.2% exhibited normal baseline renal function. Teicoplanin was most commonly used for bacteremia (n = 134), and the most common isolated pathogen being Staphylococcus aureus (n = 221). The TIT incidence was 4.6% (the possible and probable category using the Naranjo scale; 22/482). The median time to first platelet count dropped to <100 × 103/µL after teicoplanin initiation was 5 (interquartile range [IQR], 3-10) days and 8 (IQR, 5-14) days till the maximum platelet count dropped. None of the tested patient variables were found to be independently associated with an increased risk of thrombocytopenia. The overall TIT incidence was low across our study cohort, including critically ill patients. Our study results may aid in the optimal monitoring of such serious teicoplanin-induced adverse effects.

Evaluation of adverse drug reactions in patients of schizophrenia in tertiary care teaching hospitals in Central India

Background: For decades, it has been observed that mental health is shrouded in stigma and discrimination. The scope, severity, and expense of impairment and costs to people, families, and societies are staggering. Mental illnesses are among the most frequent illnesses, affecting over a quarter of the population in any given year. According to national institute of mental health and neurosciences, Bangalore, the prevalence of schizophrenia has been considered as 4/1000 for all ages and both sexes. Aim and Objectives: The objectives of this study were to as follows: (1) To evaluate adverse drug reactions (ADRs) in patients with schizophrenia who received antipsychotic treatment and (2) to compare ADRs in typical versus atypical antipsychotic agents in schizophrenic patients. Materials and Methods: A total of 50 schizophrenic patients were enrolled for evaluating adverse effects to antipsychotic drugs. During the research, all ethical precautions were taken. All patients were followed up by medical history, history of drugs, and any severity of adverse drug reaction. Causality assessment was graded by Naranjo scale. Result: Among all of the antipsychotic drugs, risperidone (05%), quetiapine (04%), and aripiprazole (04%) have shown lowest propensity to cause serious adverse event. These drugs are most commonly prescribed drugs and are least likely to affect quality of life of patient. However, the risk of extrapyramidal symptoms is lower with olanzapine (05%) than haloperidol (34%) and even in case with risperidone at higher dose (20%). Although atypical antipsychotics such as olanzapine (46%) have shown maximum potential to produce metabolic side effect such as dyslipidemia and hyperglycemia compared to that of other antipsychotics. Conclusion: The most common adverse effects were found with typical and atypical antipsychotics such as weight gain, drowsiness, constipation, sedation, dyslipidemia, and hypotension.

Spectrum of severe cutaneous adverse drug reactions among pediatric population and management options

Background: Cutaneous adverse drug reactions (CADRs) have been seen to be one of the most common adverse drug reactions in various studies, and the incidence in developing countries is thought to be higher between 2% and 5%. Moreover, severe CADRs (SCADRs) constitute 2% of all CADRS and can be life-threatening. The pediatric population too is vulnerable, and like in adults, SCADRs are associated with serious mortalities and morbidity; hence, early diagnosis and prompt treatment are the cornerstone for better survival. Objective: This study was undertaken to assess the patterns of SCARDs among pediatric patients and to identify the causative drug/drugs and establish causality using Naranjo scale and also study various treatments given including the role of corticosteroids in their management. Materials and Methods: A total of 52 pediatric patients (Results: A total of 52 patients were taken up for the study. The youngest was 9 months old, whereas the oldest was 18 years old. There were 34 (65.3%) males and 18 (34.6%) females. The most common SCADR was SJS seen in 27 (51.9%), followed by TEN in 9 (173%), SJS-TEN overlap in 8 (15.3%), DRESS in 6 (11.5%), and AGEP in 2 (3.8%). Conclusion: There is a lack of studies on SCADRs among the pediatric population and more so dilemma still exists regarding management. Thus, multiple such studies need to be carried out to establish clear-cut recommendations for the management of SCADRs in children and also to assess the role of corticosteroids in their management, particularly in a resource-poor nation like India.

Agreement between a regional pharmacovigilance centre and an adjudication committee regarding adverse drug reactions on a cohort of hospitalised children

The EREMI project was set up to collect data on adverse drug reactions (ADRs) occurring due to off-label and/or unlicensed drugs prescribed to hospitalised children in France. These events were evaluated by a regional pharmacovigilance centre (RPC) and an adjudication committee (AC). The aim of this study was to assess the agreement between these two different entities on their evaluation of ADRs. The RPC first validated the ADRs and assessed their causality using the Naranjo scale. The AC assessed then ADRs using all available information, including the RPC evaluation. The agreement on severity and nature of ADRs, role of treatment (suspect or concomitant) and drug causality was calculated using Cohen's nonparametric kappa coefficient (k). Three hundred and eighty-six events were reported in 219 children. The RPC excluded 65 events and validated 321 ADRs. Agreement was very good on nature of ADRs (k=0.85) and role of treatment (k=0.81), moderate on severity of ADRs (k=0.60) and very poor on drug causality (k=0.05). Agreement between the RPC and the AC was not constant throughout this evaluation. They troubled to agree on severe ADRs and on drug causality.

Experience in Using Antiviral Agents for the Treatment of Novel Coronavirus Infection (COVID-19) in Kyrgyzstan

The national clinical guidelines for the treatment of novel coronavirus infection (COVID-19) are the main source of information and the reference point for clinical decision-making by healthcare professionals in the Kyrgyz Republic. The recommendations presented in these documents are largely based on data from real clinical practice, but the efficacy and safety of a number of antiviral agents, the indications for which have been expanded to include COVID-19 treatment, remain unclear.The aim of the study was to conduct a retrospective pharmacoepidemiological analysis of lopinavir+ritonavir use in hospitals in the Kyrgyz Republic for the treatment of COVID-19 during the period from March until April 2020.Materials and methods: the paper describes a retrospective study of 145 medical records of patients with confirmed COVID-19 who were hospitalized in infectious disease departments/hospitals of the Kyrgyz Republic. Statistical processing was performed using Microsoft Excel 2017.Results: between 16 March 2020 and 25 April 2020, 145 patients were prescribed lopinavir+ritonavir at a dose of 200 mg + 50 mg, 2 tablets twice a day—in line with the dosage regimen recommended by the national guideline. The national guideline recommended the treatment duration of 10 days, while the actual treatment duration was 1–12 days (5.5 days on average) depending on the tolerability of the drug. The use of the drug was accompanied by adverse drug reactions (ADRs) in 78 patients (53.8%), and caused deterioration in the general condition of 73 of these patients (94.8%) which resulted in discontinuation of the drug. The most common ADRs were nausea, vomiting, diarrhoea, decreased appetite, yellowness of the skin, and, according to laboratory studies, an increase in serum levels of bilirubin, creatinine, glucose, aspartate aminotransferase and amylase activity. A retrospective assessment of the causal relationship probability according to the Naranjo scale showed an interrelation between the use of lopinavir+ritonavir and ADR development.Conclusions: the use of the lopinavir+ritonavir drug in COVID-19 patients led to deterioration of their general condition, which was severe in some cases. The data obtained indicate that the use of this drug for COVID-19 treatment is clinically unreasonable and irrational. Lopinavir+ritonavir was excluded from subsequent revisions of the clinical guidelines for the diagnosis and treatment of COVID-19 in the Kyrgyz Republic.

NEUROPSYCHIATRIC ADVERSE EFFECTS OF ANTIBACTERIAL AGENTS

Anti-bacterial are agents that inhibit bacterial growth or kills bacteria and are a sub-type of antimicrobials. These are drugs used to treat infections, but they sometimes pose a threat of adverse events. Some of these adverse events are neuropsychiatric, which are generally hard to diagnose and is often paid less attention. They account for about 30% of total Adverse drug reactions (ADRs) caused by drugs in patients without mental abnormalities. The spectrum ranges from episodes of seizure to acute psychosis. The article emphasizes the frequency of such adverse events and means to raise awareness among medical practitioners regarding the same. The various neuropsychiatric adverse effects and the agents responsible have been reviewed, along with their possible mechanisms and general management. The information for writing this review was selected by searching for keywords such as Neurotoxicity, GABA, Psychosis, Naranjo scale, and Antibiomania in databases such as Google Scholar, PubMed, Elsevier, etc. After searching the articles in the above-mentioned databases, the articles were screened concerning their importance with our work and according to their title and abstract. Additional articles were discovered by checking the references in the current study's citations. Using this method, the various neuropsychiatric adverse effects of Antibacterial agents were summarized in this review.

Acute Hemolytic Anemia Induced by Levofloxacin in A Woman With G6PD Deficiency: A Case Report

Introduction: Glucose 6-Phosphate Dehydrogenase deficiency (G6PD) is an X-linked recessive disorder recognized as the most prevalent enzyme deficiency around the world. G6PD deficiency has a high prevalence in Iran, especially in the northern regions. As we know, hemolysis in G6PD patients was not reported with levofloxacin previously. Case Report: In this report, we introduce a 54-year-old G6PD deficient woman who experienced the symptoms of hemolytic anemia following completion of treatment with levofloxacin. Result: After ruling out other causes of hemolysis, by using the Naranjo scale, levofloxacin was considered as a possible cause of hemolysis. Conclusion: Though the hemolytic anemia induced by levofloxacin is extremely rare in G6PD deficient patients, drug-induced hemolytic anemia should be considered as one of the differential diagnoses. It would be appropriate to use an alternative antibiotic instead of levofloxacin in a G6PD deficient patient.

Hemorrhagic Events in Patients Receiving Heparin or Enoxaparin in Combination With Oral Antithrombotics, NSAIDs, and Antiplatelet Medications: A Multi-Center Case-Series Study

Background: Hemorrhagic events are amongst the significant adverse effects of injectable anticoagulants such as heparin and enoxaparin. This undesirable effect needs close monitoring of their use for clinically relevant drug-drug interactions.&#x0D; Objectives: To study the rate of hemorrhagic events, the anatomical site, and the severity of the bleeding in patients receiving heparin or enoxaparin in combination with clopidogrel, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), and warfarin.&#x0D; Methods: We designed a prospective, multi-center, case-series study. Patients admitted to two teaching hospitals who received either an NSAID, or warfarin, or clopidogrel were evaluated. Any hemorrhagic event was recorded by Yellow Card Scheme. Also, the Naranjo scale was utilized for causality assessment.Results: A total of 123 patients were eligible for inclusion. They were admitted between November 2014 and April 2015. Sixty-five patients (52.5%) received heparin and 58 patients (47.2%) received enoxaparin. Of 123 patients, 115 patients (93.5%) received aspirin, 69 (56.1%) warfarin, 34 (27.6%) an antiplatelet medication, and 121 (98.4%) NSAIDs in combination with heparin or enoxaparin. Overall, 26 cases (21.1%) of the hemorrhagic incident were reported, of whom six cases (4.9%) were categorized as major bleeding. Patients receiving heparin constituted the largest proportion among all 26 hemorrhagic incidents (57.7%). All patients with the hemorrhagic incident had aspirin in their medication regimen, while 19 patients (73.0%) were concomitantly receiving warfarin as well. Hematuria (46.2%), hematoma in the injection site (38.5%), and hematoma (34.6%) were the top three types of hemorrhagic events. In Naranjo scale analysis, 19 patients scored more than 9 points, indicating a definite Adverse Drug Reaction (ADR) causality. Moreover, seven patients scored 5 to 8, affirming a possible association with ADR.&#x0D; Conclusion: The risk of hemorrhagic can be influenced by undesirable drug-drug interactions. Close monitoring of high-risk patients is advised to prevent adverse hemorrhagic reactions. Further studies to detect the explanatory factors associated with the hemorrhagic events are recommended.&#x0D;