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Current Drug Safety

Menelaos Kanakis, Ilias Georgalas, Thomas Makatsoris, Nikolaos Pharmakakis
PURPOSE: To report a case of a 73-year-old man who presented with decreased visual acuity due to bilateral macular edema after paclitaxel administration for prostate cancer. METHODS: The ophthalmic evaluation consisted of medical and ocular history, Best Corrected Visual Acuity (BCVA), slit-lamp biomicroscopy and Spectral-domain optical coherence tomography (SD-OCT) / Fluorescein Angiography. RESULTS: Optical coherence tomography and Fluorescein Angiography revealed silent cystoid macular edema...
August 28, 2018: Current Drug Safety
Ornella Spagnolello, Federica Letteri, Anne Falcou, Lorena Cipollone, Manuela De Michele, Giuliano Bertazzoni, Danilo Toni
The widespread use of direct oral anticoagulants (DOACs) has been increasing the conditions in which emergency physicians are forced to rapidly reverse anticoagulation in case of life-threatening bleeding or need of urgent surgery or invasive procedures. Recent approval of Idarucizumab, a humanized monoclonal antibody fragment (Fab), offered the opportunity to rapidly and safely neutralize the anticoagulant effect of Dabigatran. However, real world experience of its effective use in different emergency setting is now required...
August 16, 2018: Current Drug Safety
Asma H Almaghrebi
BACKGROUND: The clozapine-derivative quetiapine has been shown in some cases to cause leukopenia and neutropenia. CASE PRESENTATION: We reported on a case of a young female diagnosed with treatment-resistant schizophrenia. After failed trials of three antipsychotic medications and despite a history of quetiapine-induced leukopenia, clozapine treatment was introduced due to the severity of the patient's symptoms, the limited effective treatment options, and a lack of guidelines on this issue...
August 6, 2018: Current Drug Safety
Vikramjeet Singh, Angelika Batta
BACKGROUND: Fixed drug eruption is a clinical entity occurring at the same site each time the drug is administered. They are usually found on lips, genitalia, abdomen, and legs but can occur at any location. The eruptions usually occur within hours of administration of the drug and resolves spontaneously. Most common drugs causing them include antimicrobials. Fluroquinolones especially norfloxacin is commonly used in the treatment of gastrointestinal infections. Cutaneous adverse drug reactions are very rare with norfloxacin...
August 6, 2018: Current Drug Safety
Aashiq Ahamed Shukkoor, Saravanan Thangavelu, Nimmy Elizabeth George, Shanmuga Priya
Dapsone is a sulfone derived drug used in the treatment of leprosy and several chronic inflammatory dermatological diseases. Dapsone hypersensitivity syndrome (DHS) is characterized by fever, hepatitis, generalized exfoliative dermatitis and lymphadenopathy. It is rare and potentially fatal. We present a case report of a 52 years old female with a recent history of antecedent dapsone exposure of 100 mg daily for 2 weeks. She developed fever 10 days after exposure to dapsone therapy and was treated in various primary and tertiary centers for features of sepsis...
July 31, 2018: Current Drug Safety
Kerasia-Maria Plachouri, Eleftheria Vryzaki, Sophia Georgiou
BACKGROUND: The introduction of Immune Checkpoint Inhibitors in the recent years has resulted in high response rates and extended survival in patients with metastatic/advanced malignancies. Their mechanism of action is the indirect activation of cytotoxic T-cells through the blockade of inhibitory receptors of immunmodulatory pathways, such as cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), programmed cell death protein-1 (PD-1) and its ligand (PD-L1). Despite their impressive therapeutic results, they can also induce immune-related toxicity, affecting various organs, including the skin...
July 29, 2018: Current Drug Safety
Neel Prabha, Namrata Chhabra
Aceclofenac is a phenylacetic acid derivative belongs to the group of non-steroidal anti-inflammatory drug. It is commonly used in the treatment of pain and various inflammatory disorders. It is well tolerated, with most adverse events being minor and reversible and affecting mainly the GI system. Here, we report a rare occurrence of non-pigmenting fixed drug eruption after the use of aceclofenac in a 19 year old female.
July 25, 2018: Current Drug Safety
Rosa Lovero, Giuseppe Losurdo, Marcella Mastromauro, Nicola Maurizio Castellaneta, Antonio Mongelli, Antonietta Gentile, Alfredo Di Leo, Mariabeatrice Principi
BACKGROUND: Ustekinumab is a fully human monoclonal antibody which binds interleukin (IL)-12/23. It is indicated for the treatment of moderate-severe psoriasis and active psoriatic arthritis. Few data are available about the possibility of an interaction between ustekinumab and the liver. CASE DESCRIPTION: We report a case of a 61-year old woman admitted into our Unit for severe transaminase elevation (aspartate transaminase 756 IU/l, alanine transaminase 1212 IU/l) occurred after a single Ustekinumab infusion for psoriasis...
July 19, 2018: Current Drug Safety
Eman I Ahmed, Wafaa Y Abdel Wahed, Essam A Hassan, Tarek I Ahmed
BACKGROUND: Different combinations of Direct Antiviral Agents (DAAs) have been used against different hepatitis C virus (HCV) genotypes and in different types of patients. Despite being effective and characterized by a very low rate of adverse effects in clinical trials, few data are available on adverse events in real life studies. OBJECTIVES: The aim of this study was to identify the incidence and pattern of Adverse Drug Reactions (ADRs) caused by DAAs; daclatasvir and sofosbuvir and their combination with ribavirin and to assess the causality and the severity of the reported ADRs...
July 15, 2018: Current Drug Safety
Andrea D Pratico, Laura Longo, Silvana Mansueto, Lucia Gozzo, Ignazio Barberi, Venera Tiralongo, Vincenzo Salvo, Raffaele Falsaperla, Giovanna Vitaliti, Mario La Rosa, Antonio Rotondo, Nicoletta Avola, Debora Sgarlata, Annalisa Damiano, Massimo Tirantello, Gaspare Anzelmo, Domenico Cipolla, Angelo Rizzo, Antonio Russo, Martino Ruggieri, Salvatore Salomone, Filippo Drago
BACKGROUND: Given the growing use of off-label in pediatric practice, there is a growing interest on pharmacovigilance programs monitoring the occurrence of adverse drug reactions related to off-label drug prescription in childhood. PATIENTS AND METHODS: The results of a one-year program of pharmacovigilance issued in the Sicilian Region, Italy, are herein presented. The study involved 6 pediatric and neonatal centres and prospectively reviewed the prescriptions of 5,060 patients, who were stratified for age (newborn, infant, children, adolescents)...
June 19, 2018: Current Drug Safety
Olga E Makri, Iasonas K Tsekouras, Panagiotis Plotas, Foteini Tsapardoni, Athina Pallikari, Constantine D Georgakopoulos
We present an interesting case of accidental overdose of latanoprost eye drops. A 71-year-old patient underwent an uncomplicated cataract surgery in his right eye. During the first postsurgical week he mistakenly used latanoprost eye drops six times daily instead of the prescribed tobramycin/dexamethasone eye drops. The patient experienced gradually decreasing visual acuity and was diagnosed with cystoid macular edema seven weeks after surgery. The cystoid macular edema resolved 4 weeks later after treatment with nepafenac 0...
June 19, 2018: Current Drug Safety
Elias E Mazokopakis
Elevations in serum parathyroid hormone (PTH) levels after denosumab administration have been described in medical literature among patients with renal impairment or intestinal malabsortion syndromes. We present the first case of denosumab-induced normocalcemic hyperparathyroidism in a woman with postmenopausal osteoporosis without renal impairment or malabsorption syndrome.
June 7, 2018: Current Drug Safety
Manjeet Singh Jangra, Manik Chhabra
INTRODUCTION: Cycloserine and Kanamycin are approved for treatment of multidrug-resistant tuberculosis with good tolerability in Tuberculosis patients and have various labeled adverse reactions but the neuropsychiatric adverse drug reactions with the cycloserine are rarely explained. METHODS: We present a case report on Cycloserine induced Suicidal tendencies and Kanamycin induced decrease in hearing sensation in Indian MDR-TB patient. CASE REPORT: A 55-year-old male patient who was diagnosed with MDR-TB was prescribed with category IV anti-tubercular therapy...
June 4, 2018: Current Drug Safety
John Read, James Williams
BACKGROUND: Studies of the adverse effects of antidepressants tend to focus on biological symptoms. The prevalence of suicidality and withdrawal effects are currently a source of controversy. OBJECTIVE: To directly ascertain the experiences of an international sample of antidepressant users. METHOD: An online survey asked adult antidepressant users whether they had experienced 20 adverse effects 'as a result of taking the antidepressant', and if so, to what degree of severity...
June 4, 2018: Current Drug Safety
Aakriti Garg, Anoop Kumar
Background Recently, Food and Drug Administration (FDA) has approved Dulaglutide (GLP-1 analog) for the treatment of type 2 diabetes mellitus. However, regarding adverse drug reactions (ADRs) of Dulaglutide in large group of population, very less information is available. Thus, in the present investigation, we have tried to find out the risk & benefit profile of Dulaglutide. Material & Methods The data related to risk and benefit profile of Dulaglutide has been extracted from various sources like Pub-Med, Regulatory Websites of various agencies, Clinical trial registry etc...
May 31, 2018: Current Drug Safety
Devis Benfaremo, Lucia Manfredi, Michele Maria Luchetti, Armando Gabrielli
BACKGROUND: Immune checkpoint inhibitors are a new promising class of antitumor drugs that have been associated to a number of immune-related adverse events (AEs), including musculoskeletal and rheumatic disease. METHODS: We searched Medline reviewing reports of musculoskeletal and rheumatic AEs induced by immune checkpoint inhibitors. RESULTS: Several musculoskeletal and rheumatic AEs associated with immune checkpoint inhibitors treatment are reported in literature...
May 8, 2018: Current Drug Safety
Tuck Y Yong, Kareeann S.F. Khow
Hyponatraemia is frequently encountered in clinical practice and common among hospitalized patients. Tramadol is a commonly prescribed analgesia with few adverse effects. However, on rare occasions, tramadol has been found to be associated with hyponatraemia. In two patients described in this report, tramadol use was associated with symptomatic hyponatraemia which required hospitalization. Hyponatraemia were corrected after discontinuation of tramadol. A small number of patients with tramadol-associated hyponatraemia have been reported in the English-language medical literature...
May 8, 2018: Current Drug Safety
Mayssan Muftah, Rama Nassri, Ammar Nassri, Paul Harford
Acute Eosinophilic Pneumonia (AEP) is a rare, potentially fatal disease often characterized by a short febrile illness, hypoxemic respiratory failure, diffuse pulmonary opacities and evidence of pulmonary eosinophilia. AEP can be idiopathic, but has documented associations with multiple drugs. We present the first case highlighting Sertraline specifically as a cause of drug-induced AEP in the English literature.
April 2, 2018: Current Drug Safety
Dhruvkumar Patel, Mukundkumar V Patel, Sanjay L Rajput, Kamal Sharma
INTRODUCTION: 36 out of 100 cases of retrosternal chest pains are due to oesophageal pathologies and pill-induced oesophagitis(PIO) is one of them. PIO can present as retrosternal chest pain associated with various gastrointestinal (GI) symptoms and require a high index of suspicion. PIO is a clinical diagnosis; and oesophagogastroscopy is required for confirmation of the diagnosis, to find out complications of PIO and to rule out other oesophageal disorders. Our aims of the present study were to study clinical profile, risk factors and endoscopic features of PIO...
February 26, 2018: Current Drug Safety
Miia Artama, Hanna Rinta-Kokko, Hanna Nohynek, Jukka Jokinen, Arto A Palmu
BACKGROUND: In clinical trials of Pneumococcal Conjugate Vaccines (PCV), some adverse events have been reported more frequently in the PCV vaccinated. Ten-valent PCV (PCV10) was introduced into the Finnish National Vaccination Programme (NVP) in September 2010. OBJECTIVE: We conducted an ecologic register-based study to investigate further the reported adverse events after PCV. METHODS: This study included data obtained from the Finnish nationwide, population-based registers...
2018: Current Drug Safety
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