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adverse drug withdrawal reactions

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https://www.readbyqxmd.com/read/29623185/spontaneously-reported-adverse-drug-events-related-to-tapentadol-and-oxycodone-naloxone-in-australia
#1
Carmen Abeyaratne, Samanta Lalic, J Simon Bell, Jenni Ilomäki
Background: The rapid increase in prescribing and use of opioids for noncancer pain has coincided with an increase in opioid-related adverse drug events (ADEs). The objective of our study was to describe ADEs related to tapentadol and oxycodone/naloxone spontaneously reported to the Australian Therapeutic Goods Administration (TGA). Methods: Public case detail reports for tapentadol (September 2013-March 2017) and oxycodone/naloxone (April 2011-March 2017) were sourced from the TGA...
April 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/29618978/is-there-a-potential-of-misuse-for-venlafaxine-and-bupropion
#2
Fabrizio Schifano, Stefania Chiappini
Objective: Traditionally, studies on the non-medical use of pharmaceutical products have focused on controlled substances; e.g., opiates/opioids; and benzodiazepines. Although both bupropion and venlafaxine have been reported as being misused, only anecdotal reports have been made available so far. Hence, the European Monitoring Agency (EMA) Adverse Drug Reactions (ADRs), misuse/abuse/dependence and withdrawal, venlafaxine- and bupropion-related, database was here analyzed. Methods: All EMA spontaneous reports relating to venlafaxine (2005-2016) and bupropion (2003-2016) notifications were here analyzed, to provide a descriptive analysis by source, gender, age, and type of report...
2018: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29609830/safety-data-and-withdrawal-of-hepatotoxic-drugs
#3
Samy Babai, Laurent Auclert, Hervé Le-Louët
BACKGROUND AND AIM: The occurrence of drug induced liver injury (DILI) is the most common reason of post-marketing withdrawals. DILI in humans is difficult to predict using in vitro cytotoxicity screening and animal studies. A review of hepatotoxicity data was performed with the aim of identifying relevant factors that could have predicted the occurrence of serious DILI. METHODS: The drugs withdrawn from the market due to hepatotoxicity in Europe and/or in USA either by marketing authorization holders or by Regulatory agencies from 1997 to 2016 were selected...
February 21, 2018: Thérapie
https://www.readbyqxmd.com/read/29588576/a-4-year-non-randomized-comparative-phase-iv-study-of-early-rheumatoid-arthritis-integrative-anthroposophic-medicine-for-patients-with-preference-against-dmards-versus-conventional-therapy-including-dmards-for-patients-without-preference
#4
Harald J Hamre, Van N Pham, Christian Kern, Rolf Rau, Jörn Klasen, Ute Schendel, Lars Gerlach, Attyla Drabik, Ludger Simon
Background: While disease-modifying antirheumatic drugs (DMARDs) are a mainstay of therapy for rheumatoid arthritis (RA), some patients with early RA refuse DMARDs. In anthroposophic medicine (AM), a treatment strategy for early RA without DMARDs has been developed. Preliminary data suggest that RA symptoms and inflammatory markers can be reduced under AM, without DMARDs. Patients and methods: Two hundred and fifty-one self-selected patients aged 16-70 years, starting treatment for RA of <3 years duration, without prior DMARD therapy, participated in a prospective, non-randomized, comparative Phase IV study...
2018: Patient Preference and Adherence
https://www.readbyqxmd.com/read/29588298/severe-immune-thrombocytopaenia-in-a-patient-taking-benznidazole-for-chronic-chagas-disease
#5
Clara Crespillo-Andújar, María Calbacho Robles, Francesca F Norman, Jose A Pérez-Molina
Chagas disease is a parasitic disease that mostly affects Latin American countries, but it has currently become a worldwide epidemic due to migration. Both drugs marketed for its treatment (benznidazole and nifurtimox) are associated with a high rate of adverse reactions. Benznidazole is preferred initially because of its more favourable toxicity profile and perceived greater efficacy. Hypersensitivity dermatological reactions, gastrointestinal and neurological disturbances represent the most common drug-related adverse events...
March 27, 2018: BMJ Case Reports
https://www.readbyqxmd.com/read/29554696/clozapine-induced-dress-syndrome-a-case-series-from-the-amsp-multicenter-drug-safety-surveillance-project
#6
B Sanader, R Grohmann, P Grötsch, T Schumann, S Toto, P Fernando, S Stübner
Drug reaction with eosinophilia and systemic symptoms (DRESS) is an infrequent, but severe, adverse drug-induced reaction which occurs due to massive T-cell stimulation resulting in cytotoxicity and eosinophil activation and recruitment. The incidence is 0.4 cases per 100, 0000 in the general population; the mortality rate is up to 10%. Therefore, we believe that recognizing this syndrome is of particular importance. The problem we notice is that DRESS is often seen and described in patients receiving rheumatologic or anticonvulsant drugs, but very rarely in psychiatric hospitals, where Clozapine is frequently used, and that is the importance of this paper...
March 19, 2018: Pharmacopsychiatry
https://www.readbyqxmd.com/read/29543325/pharmacological-interventions-for-benzodiazepine-discontinuation-in-chronic-benzodiazepine-users
#7
REVIEW
Lone Baandrup, Bjørn H Ebdrup, Jesper Ø Rasmussen, Jane Lindschou, Christian Gluud, Birte Y Glenthøj
BACKGROUND: Prolonged treatment with benzodiazepines is common practice despite clinical recommendations of short-term use. Benzodiazepines are used by approximately 4% of the general population, with increased prevalence in psychiatric populations and the elderly. After long-term use it is often difficult to discontinue benzodiazepines due to psychological and physiological dependence. This review investigated if pharmacological interventions can facilitate benzodiazepine tapering. OBJECTIVES: To assess the benefits and harms of pharmacological interventions to facilitate discontinuation of chronic benzodiazepine use...
March 15, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29535124/efficacy-and-safety-of-biologics-in-relapsing-polychondritis-a-french-national-multicentre-study
#8
Guillaume Moulis, Grégory Pugnet, Nathalie Costedoat-Chalumeau, Alexis Mathian, Gaëlle Leroux, Jonathan Boutémy, Olivier Espitia, Laurence Bouillet, Sabine Berthier, Jean-Baptiste Gaultier, Pierre-Yves Jeandel, Amadou Konaté, Arsène Mékinan, Elisabeth Solau-Gervais, Benjamin Terrier, Daniel Wendling, Fanny Andry, Camille Garnier, Pascal Cathébras, Laurent Arnaud, Aurore Palmaro, Patrice Cacoub, Zahir Amoura, Jean-Charles Piette, Philippe Arlet, Maryse Lapeyre-Mestre, Laurent Sailler
OBJECTIVES: To assess the efficacy and the safety of biologics in a cohort of patients with relapsing polychondritis (RP). METHODS: We conducted a French multicentre retrospective cohort study including patients treated with biologics for RP. Efficacy outcomes were clinical response (partial or complete) and complete response during the first 6 months of exposure, plus daily corticosteroid dose at 6 months. Other outcomes were adverse drug reactions (ADRs), persistence of biologics and factors associated with a response...
March 13, 2018: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/29534693/severe-eye-complications-from-toxic-epidermal-necrolysis-following-initiation-of-nevirapine-based-haart-regimen-in-a-child-with-hiv-infection-a-case-from-cameroon
#9
Xavier Tchetnya, Calypse Asangbe Ngwasiri, Tiayah Munge, Leopold Ndemnge Aminde
BACKGROUND: Toxic epidermal necrolysis (TEN) is a rare life threatening dermatological disorder characterized by extensive epidermal detachment and erosion of mucous membranes. It is typically a side effect of some medications. Nevirapine, a nonnucleoside reverse transcriptase inhibitor (NNRTI) is one of the frequently used components of highly active antiretroviral therapy (HAART). Skin rash is its common adverse reaction, usually mild and rarely progressing to TEN. Ophthalmic involvement is common as well but rarely progresses to blindness especially in the pediatric population...
March 13, 2018: BMC Pediatrics
https://www.readbyqxmd.com/read/29527022/acute-generalised-exanthematous-pustulosis-an-update
#10
Abhishek De, Sudip Das, Aarti Sarda, Dayamay Pal, Projna Biswas
Acute generalised exanthematous pustulosis (AGEP) is a severe cutaneous adverse reaction and is attributed to drugs in more than 90% of cases. It is a rare disease, with an estimated incidence of 1-5 patients per million per year. The clinical manifestations characterised by the rapid development of sterile pustular lesions, fever and leucocytosis. Number of drugs has been reported to be associated with AGEP, most common being the antibiotics. Histopathologically there is intraepidermal pustules and papillary dermal oedema with neutrophilic and eosinophilic infiltrations...
January 2018: Indian Journal of Dermatology
https://www.readbyqxmd.com/read/29475566/nicorandil-and-cutaneous-ulcerations-their-misdiagnosis-and-consequences-illustration-by-five-cases-reports-and-a-review-of-the-french-pharmacovigilance-database
#11
Johana Béné, Olivier Carpentier, Sonia Sabanowski, Marie-Laure Laroche, Marie-Noëlle Beyens, Marc Lambert, Sophie Gautier
While physicians increasingly recognize nicorandil-related mucocutaneous ulcerations, there are still misdiagnoses, particularly in the case of unusual location and late onset ulceration after nicorandil introduction. The goal of our study was to remind clinicians about the link between nicorandil use and the development of cutaneous ulcerations and to highlight the risk of misdiagnosis. We describe five reports diagnosed by the same dermatologist, complemented by an analysis of the French pharmacovigilance database (FPVD) from 1 January 1994 to 5 January 2017...
January 31, 2018: Thérapie
https://www.readbyqxmd.com/read/29457009/acneiform-rash-caused-by-an-unlikely-drug-topiramate
#12
Yesenia Bello-Hernández, Jessica Espinoza-Hernández, Gabriela Moreno-Coutiño
Topiramate is an antiepileptic drug that can also be used for migraine prophylaxis, weight control, and even for methamphetamine dependence; the dosage margin is wide, and the list of side effects is shorter than with other anticonvulsants. We present the case of a 35-year-old man with a disseminated rash of the trunk and extremities after treatment with 25 mg of topiramate daily as a prophylactic migraine treatment. This case report is useful, as this patient was not polymedicated and had a score of 7 on the Naranjo Adverse Drug Reaction Probability Scale...
January 2018: Skin Appendage Disorders
https://www.readbyqxmd.com/read/29362275/investigation-assessing-the-publicly-available-evidence-supporting-postmarketing-withdrawals-revocations-and-suspensions-of-marketing-authorisations-in-the-eu-since-2012
#13
Samantha Lane, Elizabeth Lynn, Saad Shakir
OBJECTIVES: To assess the sources of publicly available evidence supporting withdrawal, revocation or suspension of marketing authorisations ('regulatory actions') due to safety reasons in the EU since 2012 and to investigate the time taken since initial marketing authorisation to reach these regulatory decisions. SETTING: This investigation examined the sources of evidence supporting 18 identified prescription medicinal products which underwent regulatory action due to safety reasons within the EU in the period 1 July 2012 to 31 December 2016...
January 23, 2018: BMJ Open
https://www.readbyqxmd.com/read/29350109/tertiary-care-experience-of-sorafenib-in-the-treatment-of-progressive-radioiodine-refractory-differentiated-thyroid-carcinoma-a-korean-multicenter-study
#14
Mijin Kim, Tae Hyuk Kim, Dong Yeob Shin, Dong Jun Lim, Eui Young Kim, Won Bae Kim, Jae Hoon Chung, Young Kee Shong, Bo Hyun Kim, Won Gu Kim
BACKGROUND: Sorafenib, a multi-kinase inhibitor, is approved for the treatment of patients with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). This study evaluated the efficacy and safety of sorafenib in real-world clinical practice and compared the results to those of the DECISION trial. The clinical features associated with better clinical outcomes after sorafenib treatment were also evaluated. METHODS: This multicenter, retrospective cohort study evaluated 98 patients with progressive RAI-refractory DTC who were treated with sorafenib in six tertiary hospitals in Korea...
March 2018: Thyroid: Official Journal of the American Thyroid Association
https://www.readbyqxmd.com/read/29343941/clinical-features-of-hypophosphatemic-osteomalacia-induced-by-long-term-low-dose-adefovir-dipivoxil
#15
Sheng Zhu, Yu-Hui Yang, Rong-Wei Gao, Ran Li, Yu-Zhen Zou, Lei Feng, Bo Zhang
Objective: To investigate the predictors of hypophosphatemic osteomalacia induced by adefovir dipivoxil (ADV) and to monitor for early detection. Patients and methods: Hospitalized patients who were diagnosed with ADV-related hypo-phosphatemic osteomalacia were recruited and retrospectively analyzed in our hospital from January 2012 to December 2016. A telephone interview was conducted at 1, 3, 6, 9, 12, and 24 months after cessation of ADV. Results: In the 8 patients enrolled in the study, the hypophosphatemic osteomalacia symptoms developed at an average of 5...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29343268/time-homogeneous-markov-process-for-hiv-aids-progression-under-a-combination-treatment-therapy-cohort-study-south-africa
#16
Claris Shoko, Delson Chikobvu
BACKGROUND: As HIV enters the human body, its main target is the CD4 cell which it turns into a factory that produces millions of other HIV particles. These HIV particles target new CD4 cells resulting in the progression of HIV infection to AIDS. A continuous depletion of CD4 cells results in opportunistic infections, for example tuberculosis (TB). The purpose of this study is to model and describe the progression of HIV/AIDS disease in an individual on antiretroviral therapy (ART) follow up using a continuous time homogeneous Markov process...
January 18, 2018: Theoretical Biology & Medical Modelling
https://www.readbyqxmd.com/read/29282040/case-report-atypical-presentation-of-vancomycin-induced-dress-syndrome-a-case-report-and-review-of-the-literature
#17
Olivia Wilcox, Mohamed Hassanein, John Armstrong, Nader Kassis
BACKGROUND: Drug reaction with eosinophilia and systemic symptoms (DRESS) is a severe hypersensitivity drug reaction involving the skin and multiple internal organ systems. The symptoms typically present with fever and skin rash, and rapidly progress to multiple organ failures. Vancomycin is a rare drug to cause DRESS syndrome with 23 cases reported to date. CASE PRESENTATION: We described a case of a 39 year-old man who was treated with vancomycin for osteomyelitis of the foot...
December 28, 2017: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/29274824/antituberculosis-drug-associated-dress-a-case-series
#18
Marion Allouchery, Sophie Logerot, Judith Cottin, Pauline Pralong, Céline Villier, Benoit Ben Saïd
BACKGROUND: Although antituberculosis drug-associated drug reaction with eosinophilia and systemic symptoms (DRESS) is rarely reported, its diagnosis should not be dismissed. Its management implies an early withdrawal of suspected drugs. OBJECTIVE: The objective of this study was to describe the characteristics of antituberculosis drug-associated DRESS and to identify the most likely involved drugs. METHODS: We searched for potential cases of DRESS with rifampicin, isoniazid, pyrazinamide, and ethambutol reported from January 1, 2005, to July 30, 2015, in the French pharmacovigilance database...
December 20, 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/29239026/early-cutaneous-eruptions-after-oral-hydroxychloroquine-in-a-lupus-erythematosus-patient-a-case-report-and-review-of-the-published-work
#19
Tomoko Matsuda, Nhung Thi My Ly, Naotomo Kambe, Chuyen Thi Hong Nguyen, Ikuko Ueda-Hayakawa, Yonsu Son, Hiroyuki Okamoto
Hydroxychloroquine (HCQ) is an effective treatment of lupus erythematosus. Although adverse effects, mainly gastrointestinal and cutaneous manifestations, are rare, they may result in the cessation of medication in some patients with severe reactions. Therefore, the evaluation of a patient's condition is important for a dermatologist to decide whether to cease or continue HCQ. We herein report a case of a 36-year-old Japanese woman with systemic lupus erythematosus and cutaneous eruptions caused by the p.o...
March 2018: Journal of Dermatology
https://www.readbyqxmd.com/read/29224298/-smoking-abstinence-rate-and-its-associated-factors-between-abrupt-and-gradual-smoking-cessation
#20
R Hao, J P Zhou, L Ni, Q Y Li, G C Shi
Objective: To analyze and compare the abstinence rate of smoking quitting methods and its associated factors between abrupt and gradual smoking cessation in smokers with drug-based therapy. Methods: A prospective clinical study was conducted in patients undergoing quitting smoking intervention in Ruijin Hospital smoking cessation clinic between June 2013 and May 2016. All the subjects were randomized in a 1∶1 ratio into the abrupt smoking cessation group (smoking as usual over 3 weeks before a planned quit day, and then stopping smoking abruptly) and the gradual smoking cessation group (gradually reducing tobacco use over 3 weeks before a planned quit day, and then stopping smoking totally)...
December 12, 2017: Chinese Journal of Tuberculosis and Respiratory Diseases
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