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adverse drug withdrawal reactions

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https://www.readbyqxmd.com/read/29224298/-smoking-abstinence-rate-and-its-associated-factors-between-abrupt-and-gradual-smoking-cessation
#1
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
https://www.readbyqxmd.com/read/29217288/avelumab-in-metastatic-urothelial-carcinoma-after-platinum-failure-javelin-solid-tumor-pooled-results-from-two-expansion-cohorts-of-an-open-label-phase-1-trial
#2
Manish R Patel, John Ellerton, Jeffrey R Infante, Manish Agrawal, Michael Gordon, Raid Aljumaily, Carolyn D Britten, Luc Dirix, Keun-Wook Lee, Mathew Taylor, Patrick Schöffski, Ding Wang, Alain Ravaud, Arnold B Gelb, Junyuan Xiong, Galit Rosen, James L Gulley, Andrea B Apolo
BACKGROUND: The approval of anti-programmed death ligand 1 (PD-L1) and anti-programmed death 1 agents has expanded treatment options for patients with locally advanced or metastatic urothelial carcinoma. Avelumab, a human monoclonal anti-PD-L1 antibody, has shown promising antitumour activity and safety in this disease. We aimed to assess the safety profile in patients (both post-platinum therapy and cisplatin-naive) treated with avelumab and to assess antitumour activity of this drug in post-platinum patients...
December 4, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29210868/is-there-a-potential-of-misuse-for-quetiapine-literature-review-and-analysis-of-the-european-medicines-agency-european-medicines-agency-adverse-drug-reactions-database
#3
Stefania Chiappini, Fabrizio Schifano
PURPOSE/BACKGROUND: A recent years' increase in both prescribing and availability of second-generation antipsychotics (SGAs) has been observed. According to the literature, typically made up by case studies/series, quetiapine seems to be the most commonly misused SGA, with both intranasal and intravenous intake modalities having been described. Another SGA that has been anecdotally reported to be misused is olanzapine. For these molecules, both a previous history of drug misuse and being an inmate have been described as factors associated with misuse...
November 28, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/29205444/switching-from-infliximab-innovator-to-biosimilar-in-patients-with-inflammatory-bowel-disease-a-12-month-multicentre-observational-prospective-cohort-study
#4
E M H Schmitz, P J Boekema, J W A Straathof, D C van Renswouw, L Brunsveld, V Scharnhorst, M E C van de Poll, M A C Broeren, L J J Derijks
BACKGROUND: Infliximab biosimilars have become available for treatment of inflammatory bowel disease (IBD). However, data showing long-term safety and effectiveness of biosimilars in IBD patients are limited. AIM: To study prospectively the switch from infliximab innovator to biosimilar in an IBD cohort with 12 months follow-up to evaluate safety and effectiveness. METHODS: Adult IBD patients from two hospitals treated with infliximab innovator (Remicade; Janssen Biotech,  Horsham ,  Pennsylvania, USA) were switched to infliximab biosimilar (Inflectra; Hospira, Lake Forest, Illinois, USA) as part of routine care, but in a controlled setting...
December 5, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29199808/how-to-identify-dress-drug-reaction-with-eosinophilia-and-systemic-symptoms
#5
Piia Sarajärvi, Minna Kubin, Kaisa Tasanen, Laura Huilaja
DRESS (drug reaction with eosinophilia and systemic symptoms) is a rare, severe multiorgan adverse drug reaction. Antiepileptic age's and antibiotics are the most frequently reported causative agents. Compared with other drug reactions, DRESS demonstrates a long latency period thus complicating recognition and diagnosis. DRESS is defined as presence of fever, skin eruption, hematologic abnormalities and systemic involvement, especially liver injury. Withdrawal of the culprit drug, commencement of systemic corticosteroid and supportive care are the mainstay of treatment...
2017: Duodecim; Lääketieteellinen Aikakauskirja
https://www.readbyqxmd.com/read/29190196/clinical-and-histologic-features-of-acute-onset-erythroderma-in-dogs-with-gastrointestinal-disease-18-cases-2005-2015
#6
Christine L Cain, Charles W Bradley, Elizabeth A Mauldin
OBJECTIVE To describe the clinical and histologic features of acute erythroderma in dogs with gastrointestinal disease. DESIGN Retrospective case series. ANIMALS 18 dogs with erythroderma and gastrointestinal disease. PROCEDURES Medical records and biopsy specimens were reviewed. Information collected from medical records included signalment, clinical signs, physical examination and diagnostic test results, treatment, and outcome. The Naranjo algorithm was used to estimate the probability of an adverse drug reaction for each dog...
December 15, 2017: Journal of the American Veterinary Medical Association
https://www.readbyqxmd.com/read/29168605/what-psychologists-need-to-know-about-psychotropic-medications
#7
Elena Tomba, Jenny Guidi, Giovanni A Fava
Despite the fact that today most of the patients with psychological disturbances assume some form of psychotropic drug treatment, clinical psychologists may have little familiarity with psychopharmacology and are substantially unaware of subtle and yet pervasive potential effects of medications in clinical presentations. In their training, psychologists are generally exposed, at best, to some general principles of drug action. Standard psychopharmacology textbooks tend to omit the subtle psychological changes that may occur during psychotropic drug treatment...
November 23, 2017: Clinical Psychology & Psychotherapy
https://www.readbyqxmd.com/read/29145260/reversible-severe-fatty-liver-induced-by-capecitabine-a-case-report
#8
Yiyan Jiang, Qiancheng He, Suxia Li, Chang Shi, Xiaolei Yang
RATIONALE: Capecitabine (CAP) is a chemotherapeutic agent used to treat breast and gastrointestinal cancers. The most common adverse reactions of CAP primarily included gastrointestinal and dermatological effects. Whereas, the CAP-induced fatty liver had never been reported. PATIENT CONCERNS: In this study, a-69-year old female presented a history of hypertension with regulated blood pressure, whereas diabetes mellitus, hyperlipidemia, and hepatitis were excluded...
November 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29081616/biological-response-modifiers-in-rheumatoid-arthritis-systematic-review-and-meta-analysis-of-safety
#9
Nitishkumar D Tank, Bharti N Karelia, Bhavisha N Vegada
OBJECTIVE: To analyze available evidence on the safety of different biological response modifiers which are used for a treatment of rheumatoid arthritis (RA). MATERIALS AND METHODS: We searched systematically for randomized controlled clinical trials on treatment of RA with different biological response modifiers, followed by a systematic review with meta-analysis. Trials were searched from MEDLINE and Cochrane Library databases. The following safety parameters reported in the selected trials were analyzed: number of patients suffering any adverse event (AE), withdrawal due to AEs, serious AE (SAEs), infections, serious infections, infusion reactions, injection site reactions, malignancies, and overall mortality...
July 2017: Journal of Pharmacology & Pharmacotherapeutics
https://www.readbyqxmd.com/read/29076385/post-marketing-withdrawal-of-analgesic-medications-because-of-adverse-drug-reactions-a-systematic-review
#10
Igho J Onakpoya, Carl J Heneghan, Jeffrey K Aronson
Many analgesics have been withdrawn from the market because of adverse drug reactions. Controversy still surrounds the use of some approved analgesics for pain management. However, the trends and reasons for withdrawal of analgesics when harms are attributed to their use have not been systematically assessed. Areas covered: We conducted searches in PubMed; Embase; Google Scholar; clinicaltrials.gov; WHO databases of withdrawn products; websites of the European Medicines Agency, the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency; Meyler's Side Effects of Drugs; Stephens' Detection of New Adverse Drug Reactions; the Pharmaceutical Manufacturing Encyclopedia; and the Merck Index...
November 1, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29074415/non-steroidal-anti-inflammatory-drugs-are-safe-with-respect-to-the-transcriptome-of-human-dermal-fibroblasts
#11
Paweł Mozolewski, Joanna Jakóbkiewicz-Banecka, Grzegorz Węgrzyn, Bogdan Banecki, Magdalena Gabig-Cimińska
Non-steroidal anti-inflammatory drugs (NSAIDs) provide important benefits to millions of patients, but are associated with a number of serious adverse events. These adverse drug reactions are an important clinical issue and a serious public health risk. While most unfortunate responses in human to NSAIDs are mild and may disappear after decreasing the dose or withdrawal of the drug, some of them can produce serious outcomes. Currently, little is known regarding the effects of NSAIDs on global RNA expression in normal, non-transformed cells...
October 24, 2017: European Journal of Pharmacology
https://www.readbyqxmd.com/read/29074353/clinical-features-of-regorafenib-induced-liver-injury-in-japanese-patients-from-postmarketing-experience
#12
Hiroyuki Uetake, Kenichi Sugihara, Kei Muro, Toshiyuki Sunaya, Yuka Horiuchi-Yamamoto, Hajime Takikawa
BACKGROUND: Regorafenib (Stivarga) is an oral multikinase inhibitor currently approved for patients with metastatic colorectal cancer or gastrointestinal stromal tumor. Although hepatotoxicity has been a known product profile feature of regorafenib since its initial approval, its clinical features are limited to those found in the clinical trials. PATIENTS AND METHODS: The present study was conducted in 2 analysis sets: a safety analysis set for metastatic colorectal cancer from solicited postmarketing surveillance (PMS) in Japan (n = 1227) and an analysis set for serious hepatic adverse drug reactions (n = 210) from all patients registered for regorafenib use...
September 28, 2017: Clinical Colorectal Cancer
https://www.readbyqxmd.com/read/29064136/pyridoxamine-a-novel-treatment-for-schizophrenia-with-enhanced-carbonyl-stress
#13
Masanari Itokawa, Mitsuhiro Miyashita, Makoto Arai, Takashi Dan, Katsuyoshi Takahashi, Taro Tokunaga, Kayo Ishimoto, Kazuya Toriumi, Tomoe Ichikawa, Yasue Horiuchi, Akiko Kobori, Satoshi Usami, Takeo Yoshikawa, Naoji Amano, Shinsuke Washizuka, Yuji Okazaki, Toshio Miyata
AIM: The aim of this clinical trial was to obtain proof of concept for high-dose pyridoxamine as a novel treatment for schizophrenia with enhanced carbonyl stress. METHODS: Ten Japanese schizophrenia patients with high plasma pentosidine, which is a representative biomarker of enhanced carbonyl stress, were recruited in a 24 week, open trial in which high-dose pyridoxamine (ranging from 1200 to 2400 mg/day) was administered using a conventional anti-psychotic regimen...
October 24, 2017: Psychiatry and Clinical Neurosciences
https://www.readbyqxmd.com/read/29036260/trimethoprim-sulfamethoxazole-induced-drug-eruption-with-eosinophilia-and-systemic-symptoms-dress
#14
Camila Antia, Leah Persad, Ali Alikhan
Drug rash with eosinophilia and systemic symptoms (DRESS) is a severe and potentially life threatening adverse drug reaction. To help identify DRESS, several criteria have been established; however, there is still a lack of consensus on diagnosis, and clinical judgment is paramount. Here we describe a 24-year-old female who presented with a cutaneous eruption, fever, lymphadenopathy, eosinophilia, facial edema, and elevated liver enzymes four and a half weeks after a 10-day course of Trimethoprim/sulfamethoxazole (TMP/SMX)...
October 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/29017379/hla-associated-drug-hypersensitivity-and-the-prediction-of-adverse-drug-reactions
#15
Simone Negrini, Laurent Becquemont
Adverse drug reactions are an important cause of morbidity and mortality and constitute the leading reason of drug withdrawal from the market. Besides classical reactions that are related to pharmacologic activity of the drug, some reactions are unpredictable, not dose dependent, and seem to occur in genetically predisposed individuals. The majority of this reaction is immunologically driven and they are referred to as hypersensitivity reactions. A growing number of studies provided evidences that specific HLA alleles increase the risk of developing hypersensitivity drug reactions...
October 11, 2017: Pharmacogenomics
https://www.readbyqxmd.com/read/28994899/prophylactic-antibiotics-for-preventing-pneumococcal-infection-in-children-with-sickle-cell-disease
#16
REVIEW
Angela E Rankine-Mullings, Shirley Owusu-Ofori
BACKGROUND: Persons with sickle cell disease (SCD) are particularly susceptible to infection. Infants and very young children are especially vulnerable. The 'Co-operative Study of Sickle Cell Disease' observed an incidence rate for pneumococcal septicaemia of 10 per 100 person years in children under the age of three years. Vaccines, including customary pneumococcal vaccines, may be of limited use in this age group. Therefore, prophylactic penicillin regimens may be advisable for this population...
October 10, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28950720/biomarkers-of-adverse-drug-reactions
#17
Daniel F Carr, Munir Pirmohamed
Adverse drug reactions can be caused by a wide range of therapeutics. Adverse drug reactions affect many bodily organ systems and vary widely in severity. Milder adverse drug reactions often resolve quickly following withdrawal of the casual drug or sometimes after dose reduction. Some adverse drug reactions are severe and lead to significant organ/tissue injury which can be fatal. Adverse drug reactions also represent a financial burden to both healthcare providers and the pharmaceutical industry. Thus, a number of stakeholders would benefit from development of new, robust biomarkers for the prediction, diagnosis, and prognostication of adverse drug reactions...
January 1, 2017: Experimental Biology and Medicine
https://www.readbyqxmd.com/read/28944502/immune-reconstitution-inflammatory-syndrome-in-non-hiv-immunosuppressed-patients
#18
REVIEW
Hirohiko Sueki, Yoshiko Mizukawa, Yumi Aoyama
Immune reconstitution inflammatory syndrome (IRIS) represents a clinical phenomenon of immune-mediated inflammation against various antigens, including pathogenic microorganisms, drugs and unknown autoantigens, during recovery from immunosuppressed conditions. IRIS has become well recognized in HIV-infected populations. However, IRIS has seldom been recognized in HIV-negative immunocompromised patients. In the last 15 years, the immunopathogenesis of drug-induced hypersensitivity syndrome (DIHS) has been largely determined...
September 25, 2017: Journal of Dermatology
https://www.readbyqxmd.com/read/28933008/importance-of-publishing-adverse-drug-reaction-case-reports-promoting-public-health-and-advancing-pharmacology-and-therapeutics
#19
Rashmi R Shah
This article, which encourages physicians to publish case reports of adverse drug reactions (ADRs), is a review of how well-documented published case reports have contributed to promoting public safety and health and thus served to advance basic pharmacology. The origin of a number of regulatory guidelines can ultimately be traced to safety concerns triggered by such reports. It illustrates how case reports of ADRs, when coupled with simultaneous monitoring of drug pharmacokinetics, have also led to further investigations resulting in major advances in pharmacology, especially pharmacogenetics, mechanisms of drug-drug interactions and modulation of drug metabolism during inflammatory co-morbidities...
September 20, 2017: Drug Safety—Case Reports
https://www.readbyqxmd.com/read/28905092/drug-induced-oral-lichenoid-reactions-a-real-clinical-entity-a-systematic-review
#20
REVIEW
Giulio Fortuna, Massimo Aria, Julie H Schiavo
PURPOSE: Drug-induced oral lichenoid reactions (DIOLRs) have been extensively reported in the literature, but the validity of the causality relationship between any drug and the oral lichenoid lesions (OLLs) still remains questionable. We sought to determine whether this causality relationship really exists, whether a resolution of the oral lesions upon withdrawal occurs, and what the most common alleged offending medications are. METHODS: Nine electronic databases from January 1966 to December 2016 were systematically searched to identify all relevant studies selected with specific inclusion criteria (a clinical and histopathological diagnosis of DIOLRs, and clearly statement on the systemic offending medication)...
December 2017: European Journal of Clinical Pharmacology
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