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Current Drug Safety

Ornella Moreno-Mattar, Rosana Ramírez, Andrés Alvarado, Francisco Sierra
The Colombian National Food and Drug Surveillance Institute (INVIMA) is responsible for monitoring the safety and efficacy of medicines circulating in the Colombian market. This article summarizes the strategies implemented by INVIMA to strengthen the National Pharmacovigilance Program, including the expansion of the National Pharmacovigilance Network and the implementation of the electronic submission of adverse events. Results: the number of adverse events reported in Colombia increased from 5,447 in 2013 to 95,658 in 2017, reaching a population-based reporting ratio within international standards...
November 9, 2018: Current Drug Safety
Mohammadreza Salehi, Hosein Masoumi-Asl, Mehrdad Assarian, Niloofar Khoshnam Rad, Afsaneh Motevalli Haghi, Mehran Nikbakht, Hossein Khalili
BACKGROUND: In recent years, few cases of post-artemisinin delayed hemolysis have been reported. OBJECTIVE: All cases of post-artemisinin delayed hemolysis were reported from non-middle east areas. No case of post-artemisinin delayed hemolysis has yet been reported from this region. In this paper, we describe a case of post-artemisinin delayed hemolysis in an Iranian female. Also previous reports have been reviewed. METHOD: Patient's data including demographic characteristics, past medical, drug and travelling history, present illness, vital signs, laboratory data, clinical course of current illness and follow-up findings were considered...
November 9, 2018: Current Drug Safety
Jayendra R Gohil, Sonal Jindal
Adverse cardiorespiratory events are associated with its continuous iv infusion used for sedation. Here we are reporting a case of 5 year old male child suffering from diphtheria, who received midazolam in the form of iv infusion for sedation. Six hours after starting midazolam infusion he started developing pulsus bigeminus and bradycardia and eventual death. Midazolam, although considered as one of the safest drugs, need to be used cautiously because of the possible cardiotoxic effect in an already affected heart...
November 5, 2018: Current Drug Safety
Dhruvkumar M Patel, Jayanti K Gurumukhani, Mukundkumar V Patel, Greshaben R Patel
BACKGROUND: Dyskinetic neurological diseases are common presentations of adverse reaction to many therapeutic agents. Phenytoin, a widely used age old antiepileptic drug has been reported to cause dyskinesias, a rare adverse drug reaction (ADR) in adults with toxic therapeutic serum level. When the drug is used in combination with other drugs which augments free drug level of phenytoin or in patients of organic brain lesion, this side effect is very occasionally reported with even normal therapeutic drug level...
October 31, 2018: Current Drug Safety
Ahmad Abdulrahman Almeman, Yasir Ahmed Beshir, Ahmad Hamad Aldosary
BACKGROUND: It is crucial to understand the pharmacological differences between the effects of beta blockers on the lipid and glucose profile. Moreover, the management of lipid and glucose profile is essential in cardiovascular patients. OBJECTIVE: We sought to compare two beta blockers, metoprolol and bisoprolol, as the most commonly used drugs in cardiology in terms of their effects on glucose and lipid profiles in patients with cardiovascular diseases. METHODS: We conducted a retrospective cross-sectional matched study at Prince Sultan Cardiac Center in Burydah in May 2018...
October 28, 2018: Current Drug Safety
Duygu Kınay, Ahmet Zihni Soyata
OBJECTIVE: Extrapyramidal adverse effects of antipsychotic drugs are more reported in children. Biperiden is an anticholinergic agent to treat the adverse effects of antipsychotic drugs. The drug has the potential to induce delirium at toxic doses. However, data are scarce about delirium associated with biperiden in children. Thus far, a case of delirium has been associated with biperiden in an adolescent patient. We report the first case of delirium associated with use of biperiden in a preadolescent patient...
October 28, 2018: Current Drug Safety
Viswam Subeesh, Eswaran Maheswari, Hemendra Singh, Elsa Beulah, Ann Mary Swaroop
BACKGROUND: The signal is defined as "reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously". OBJECTIVE: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System [FAERS] using Data Mining Algorithms (DMAs). METHODOLOGY: The USFDA AERS database is consist of 1028 Drug Event Combinations (DECs) were associated with iloperidone which were reported from 2010 Q1 to 2016 Q3...
October 25, 2018: Current Drug Safety
Ons Charfi, Talel Badri, Imen Aouinti, Ghozlane Lakhoua, Sarrah Kastalli, Sihem El Aidli, Ahmed Zaïem
Psoriasis is a chronic inflammatory skin disorder that may be initiated or exacerbated by some drug intakes. Some of the most common medications known to trigger or worsen existing psoriasis include lithium, gold salts, beta blockers and antimalarials. We report an exceptional case of plantar psoriasis in a woman who was treated by olmesartan for 3 years.
October 17, 2018: Current Drug Safety
Ahmed Abbas, Yusuf A Rajabally
Intravenous immunoglobulin (IVIg) forms a cornerstone of effective treatment for acute and chronic inflammatory neuropathies, with a class I evidence base in Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN). It is generally considered to be a safe therapy however there are several recognised complications which are reviewed in this article. Most adverse events are immediate and mild such as headache, fever and nausea although more serious immediate reactions such as anaphylaxis may rarely occur...
October 17, 2018: Current Drug Safety
Raafat Abdel-Malek, Kyrillus S Shohdy, Noha Abbas, Mohamed Ismail, Emad Hamada, Yasser Abdel-Kader
BACKGROUND: Several single chemotherapeutic agents have been evaluated as second line treatment of advanced urothelial carcinoma. Despite encouraging efficacy outcomes, toxicity has often led to dose modifications or discontinuation. We aimed to assess safety of vinflunine in a particular population of advanced transitional cell carcinoma of urothelium (TCCU), that were exposed to previous toxicity of chemotherapy. METHODS: This is an open-label, prospective, single center pilot study to evaluate the response rate and safety profile of vinflunine in patients with advanced TCCU...
October 1, 2018: 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
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
Neel Prabha, Namrata Chhabra
BACKGROUND: Aceclofenac is a phenylacetic acid derivative belongs to the group of nonsteroidal 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. CASE REPORT: Here, we report a rare occurrence of non-pigmenting fixed drug eruption after the use of aceclofenac in a 19 year old female.
2018: Current Drug Safety
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