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adverse drug withdrawal reactions

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https://www.readbyqxmd.com/read/28528605/fixed-combination-calcipotriene-plus-betamethasone-dipropionate-aerosol-foam-is-well-tolerated-in-patients-with-psoriasis-vulgaris-pooled-data-from-three-randomized-controlled-studies
#1
Alan Menter, Linda Stein Gold, John Koo, John Villumsen, Monika Rosén, Mark Lebwohl
The authors performed a pooled analysis of three randomized, 4-week, phase II/III studies in adult patients with mild to severe psoriasis and assessed the safety/tolerability of aerosol foam fixed-combination calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) versus different comparators. Overall, 1104 patients were randomized to Cal/BD aerosol foam (n=564), Cal aerosol foam (n=101), BD aerosol foam (n=101), aerosol foam vehicle (n=152), Cal/BD ointment (n=135), or ointment vehicle (n=51)...
2017: Skinmed
https://www.readbyqxmd.com/read/28506728/-the-effects-of-inhaled-steroids-withdrawal-in-copd
#2
G Jebrak, I Honore, P Serrier, J Dumoulin, P Terrioux, F Soyez, C Maurer, G Mangiapan, M Febvre, L-J Couderc, J-M Braun, T Chinet
The key pathophysiological feature of chronic obstructive pulmonary disease (COPD) is an abnormal inflammatory bronchial reaction after inhalation of toxic substances. The priority is the avoidance of such toxic inhalations, but the use of anti-inflammatory drugs also seems appropriate, especially corticosteroids that are the sole anti-inflammatory drug available for this purpose in France. The risks associated with the prolonged use of these parenteral drugs are well known. Inhalation is therefore the optimal route, but inhaled drugs may also lead to adverse consequences...
May 12, 2017: Revue des Maladies Respiratoires
https://www.readbyqxmd.com/read/28488610/pregabalin-and-lamotrigine-in-central-poststroke-pain-a-pilot-study
#3
Jayantee Kalita, Satish Chandra, Usha Kant Misra
BACKGROUND: Comparative study of Class I drugs in central poststroke pain (CPSP) is lacking. OBJECTIVE: To evaluate the safety and efficacy of pregabalin and lamotrigine in patients with CPSP. SETTING: Tertiary care teaching referral hospital. METHODS: We included consecutive patients with CPSP having ≥50 mm score on Visual Analog Scale (VAS) and randomized them to receive either oral pregabalin or oral lamotrigine...
May 2017: Neurology India
https://www.readbyqxmd.com/read/28487578/5%C3%AE-reductase-inhibitors-for-treatment-of-benign-prostatic-hyperplasia-a-systematic-review-and-meta-analysis
#4
REVIEW
Jennifer E J Jun, Angus Kinkade, Anthony C H Tung, Aaron M Tejani
BACKGROUND: Finasteride and dutasteride are competitive inhibitors of 5α-reductase enzymes and are commonly used to treat symptomatic benign prostatic hyperplasia (BPH). OBJECTIVE: To compare the efficacy and safety of finasteride and dutasteride in terms of clinically important outcomes. DATA SOURCES: A literature search was performed using the search terms "prostatic hyperplasia", "prostatic hypertrophy", "dutasteride", "finasteride", "quality of life", "adverse drug reaction", and "mortality"...
March 2017: Canadian Journal of Hospital Pharmacy
https://www.readbyqxmd.com/read/28482385/-a-multicenter-randomized-controlled-study-of-saccharomyces-boulardii-in-the-prevention-of-antibiotic-associated-diarrhea-in-infants-and-young-children
#5
C M Wan, H Yu, G Liu, H M Xu, Z Q Mao, Y Xu, Y Jin, R P Luo, W J Wang, F Fang
Objective: To evaluate the efficacy and safety of Saccharomyces boulardii in the prevention of antibiotic-associated diarrhea (AAD) in infants and young children. Method: From November 2012 to September 2013, ten research units of large teaching hospitals or children's hospitals participated in this multicenter randomized controlled clinical trial. Hospitalized young children aged between 1 month and 3 years (nongastrointestinal infection and antibiotic therapy required)were involved in our study. The children were randomly divided into control group and prevention group by means of block random allocation method...
May 4, 2017: Zhonghua Er Ke za Zhi. Chinese Journal of Pediatrics
https://www.readbyqxmd.com/read/28476287/severe-cutaneous-adverse-reactions-to-drugs
#6
REVIEW
Tu Anh Duong, Laurence Valeyrie-Allanore, Pierre Wolkenstein, Olivier Chosidow
During the past decade, major advances have been made in the accurate diagnosis of severe cutaneous adverse reactions (SCARs) to drugs, management of their manifestations, and identification of their pathogenetic mechanisms and at-risk populations. Early recognition and diagnosis of SCARs are key in the identification of culprit drugs. SCARS are potentially life threatening, and associated with various clinical patterns and morbidity during the acute stage of Stevens-Johnson syndrome and toxic epidermal necrolysis, drug reactions with eosinophilia and systemic symptoms, and acute generalised exanthematous pustulosis...
May 2, 2017: Lancet
https://www.readbyqxmd.com/read/28461037/post-marketing-drug-withdrawals-pharmacovigilance-success-regulatory-problems
#7
Jeffrey K Aronson
Modern pharmacovigilance began in the 1960s, since when the subject has grown markedly, interest having particularly increased since 2010. One index of its success is the increasing speed with which serious adverse drug reactions are discovered after marketing of a medicinal product. However, the speed with which products have subsequently been withdrawn as a result of the discovery of serious adverse reactions has not consistently changed. This highlights problems that regulators and manufacturers face when serious reactions are discovered, with difficulties in deciding which of several consequent actions to take: to add specific warnings (cautions) or contraindications to the product label; to issue a Direct Healthcare Professional Communication; to allow informed patients to decide whether they will take the drug; or, in the most serious cases, to withdraw the product or revoke the licence...
March 30, 2017: Thérapie
https://www.readbyqxmd.com/read/28458437/levetiracetam-induced-leukocytoclastic-vasculitis
#8
Mrinal Gupta
Drug-induced leukocytoclastic vasculitis is a small-vessel vasculitis that most commonly manifests with palpable purpuric lesions on gravity-dependent areas. Vasculitis occurs within weeks after initial administration of medication and demonstrates clearance upon withdrawal of medication. Levetiracetam, a pyrrolidone derivative, is used as an adjunctive therapy in patients with refractory focal epilepsy, myoclonic epilepsy, and primary generalized tonic-clonic seizures. We present a case of a 14-year-old female, who developed cutaneous small-vessel vasculitis within 8 days of initiation of levetiracetam...
January 2017: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28410699/anaphylaxis-to-rifampicin-and-pyrazinamide-in-a-child-with-tuberculous-meningitis-a-case-report
#9
Gulnaz Nadri, Sunil Taneja, Varinder Singh, Purvi Mittal
Rifampicin (RFP) and pyrazinamide (PZA) are the primary anti-tubercular drugs with a considerably safe profile. However, none of the drugs are without adverse reactions. They both can lead to a variety of adverse effects including life-threatening anaphylaxis. We report an interesting and possibly the first case of concurrent hypersensitivity to two primary anti-tubercular treatment (ATT) drugs. Hypersensitivity to RFP and PZA was confirmed in this patient by drug provocation and intradermal skin testing. He improved on alternative ATT regime withdrawing RFP and PZA...
April 2017: Indian Journal of Tuberculosis
https://www.readbyqxmd.com/read/28396815/catatonia-secondary-to-sudden-clozapine-withdrawal-a-case-with-three-repeated-episodes-and-a-literature-review
#10
John Bilbily, Betsy McCollum, Jose de Leon
A literature search identified 9 previously published cases that were considered as possible cases of catatonia secondary to sudden clozapine withdrawal. Two of these 9 cases did not provide enough information to make a diagnosis of catatonia according to the Diagnostic and Statistical Manual, 5th Edition (DSM-5). The Liverpool Adverse Drug Reaction (ADR) Causality Scale was modified to assess ADRs secondary to drug withdrawal. From the 7 published cases which met DSM-5 catatonia criteria, using the modified scale, we established that 3 were definitive and 4 were probable cases of catatonia secondary to clozapine withdrawal...
2017: Case Reports in Psychiatry
https://www.readbyqxmd.com/read/28355723/-a-cross-sectional-study-on-application-of-glucocorticoid-in-systemic-lupus-erythematosus-patients
#11
L L Xu, Q Y Guo, X Y Cai, Z Y Da, H Q Zhu, L Y Zhang, Y Su
Objective: To explore the status of glucocorticoid application in patients with systemic lupus erythematosus (SLE) in China. Methods: Epidemiological survey was used. The SLE patients who met the 1997 classification criteria of American College of Rheumatology were enrolled. The usage of glucocorticoid and related adverse reactions were recorded and analyzed. Results: A total of 400 SLE patients were enrolled, including 35 men and 365 women. The average age was (37.4±14.0) years old, and the average duration of disease was (6...
April 1, 2017: Zhonghua Nei Ke za Zhi [Chinese Journal of Internal Medicine]
https://www.readbyqxmd.com/read/28262178/zolpidem-s-use-for-insomnia
#12
REVIEW
Jaime M Monti, David Warren Spence, Kenneth Buttoo, Seithikurippu R Pandi-Perumal
Zolpidem is a short-acting non-benzodiazepine hypnotic drug that belongs to the imidazopyridine class. In addition to immediate-release (IR) and extended-release (ER) formulations, the new delivery forms including two sublingual tablets [standard dose (SD) and low dose (LD)], and an oral spray form have been recently developed which bypass the gastrointestinal tract. So far, Zolpidem has been studied in several clinical populations: cases poor sleepers, transient insomnia, elderly and non-elderly patients with chronic primary insomnia, and in comorbid insomnia...
February 2017: Asian Journal of Psychiatry
https://www.readbyqxmd.com/read/28238125/post-marketing-regulation-of-medicines-withdrawn-from-the-market-because-of-drug-attributed-deaths-an-analysis-of-justification
#13
Igho J Onakpoya, Carl J Heneghan, Jeffrey K Aronson
INTRODUCTION: Several medicinal products have been withdrawn from the market because of drug-attributed deaths. However, there has been no investigation of whether such withdrawals were justified, and the extent to which confirmatory studies are used to investigate drug-adverse event relationships when deaths are reported is uncertain. We documented medicinal products withdrawn from the market because of drug-attributed deaths, identified confirmatory studies investigating the drug-adverse event relationships, examined whether withdrawals of medicinal products because of drug-attributed deaths after marketing were justified based on a mechanistic analysis, and examined the trends over time...
February 25, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28231495/drug-induced-panic-attacks-analysis-of-cases-registered-in-the-french-pharmacovigilance-database
#14
Delphine Abadie, Anaïs Essilini, Virginie Fulda, Aurore Gouraud, Mélissa Yéléhé-Okouma, Joëlle Micallef, François Montastruc, Jean Louis Montastruc
BACKGROUND: The potential role of drugs in the onset of panic attacks (PAs) is poorly understood. AIM: The objective of our study was to characterize drug-induced PAs. METHOD: We performed an analysis of PAs registered in the French pharmacovigilance database between 01/01/1985 and 05/11/2014. RESULTS: Among the 163 recorded cases, 136 (83.4%) were directly related to drugs, mainly antidepressants (11.3%, mainly serotonin reuptake inhibitors), mefloquine (7...
February 9, 2017: Journal of Psychiatric Research
https://www.readbyqxmd.com/read/28225346/cd4-count-and-risk-of-anti-tuberculosis-drug-associated-cutaneous-reactions-in-hiv-infected-thai-patients
#15
L Boonyagars, P Hirunwiwatkul, C P Hurst
OBJECTIVES: Tuberculosis (TB) is a major cause of morbidity and mortality in human immunodeficiency virus (HIV) infected patients. However, anti-tuberculosis drugs can cause cutaneous adverse drug reactions (CADRs). This study was conducted to evaluate differences in CADR incidence between low and high CD4 cell count in patients with low and high CD4 cell count and to identify other risk factors for CADR in HIV-TB co-infected patients. DESIGN: In a retrospective cohort of adult HIV-TB co-infected patients receiving standard anti-tuberculosis treatment between January 2008 and December 2015 at Vajira Hospital, Bangkok, Thailand, baseline demographic, clinical characteristics and factors associated with CADRs, including CD4 cell count status, were collected...
March 1, 2017: International Journal of Tuberculosis and Lung Disease
https://www.readbyqxmd.com/read/28192425/improving-access-to-chagas-disease-diagnosis-and-etiologic-treatment-in-remote-rural-communities-of-the-argentine-chaco-through-strengthened-primary-health-care-and-broad-social-participation
#16
Paula Sartor, Ivana Colaianni, M Victoria Cardinal, Jacqueline Bua, Héctor Freilij, Ricardo E Gürtler
BACKGROUND: Rural populations in the Gran Chaco region have large prevalence rates of Trypanosoma cruzi infection and very limited access to diagnosis and treatment. We implemented an innovative strategy to bridge these gaps in 13 rural villages of Pampa del Indio held under sustained vector surveillance and control. METHODOLOGY: The non-randomized treatment program included participatory workshops, capacity strengthening of local health personnel, serodiagnosis, qualitative and quantitative PCRs, a 60-day treatment course with benznidazole and follow-up...
February 2017: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/28188894/emerging-rna-editing-biomarkers-will-foster-drug-development
#17
REVIEW
Siem van der Laan, Nicolas Salvetat, Dinah Weissmann, Franck Molina
Unanticipated adverse drug reactions (ADRs) on the central nervous system are a major cause of clinical attrition and market withdrawal. Current practices for their prospective assessment still lean on extensive analysis of rodent behaviour despite their highly controversial predictive value. Human-derived in vitro models that objectively quantify mechanism-related biomarkers can greatly contribute to better ADR prediction at early developmental stages. Adenosine-to-inosine RNA editing constitutes a physiological cellular process that translates environmental cues by regulating protein function at the synaptic level in health and disease...
February 7, 2017: Drug Discovery Today
https://www.readbyqxmd.com/read/28167593/a-review-on-dapsone-hypersensitivity-syndrome-among-chinese-patients-with-an-emphasis-on-preventing-adverse-drug-reactions-with-genetic-testing
#18
Na Wang, Leela Parimi, Hong Liu, Furen Zhang
AbstractDapsone is a bactericidal and bacteriostatic against Mycobacterium leprae, a causative agent of leprosy. Dapsone is also applied in a range of medical fields because of its anti-inflammatory and immunomodulatory effects. Dapsone hypersensitivity syndrome (DHS) is a rare yet serious adverse drug reaction (ADR) caused by dapsone involving multiple organs. We performed a systematic review of published articles describing dapsone-induced hypersensitivity syndrome, including all Chinese articles and the latest literature available in online databases published between October 2009 and October 2015...
May 2017: American Journal of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/28166916/black-brown-discoloration-and-hairy-tongue-a-rare-linezolid-side-effect
#19
A K Jain, Man Mohan Puri, R Sarin
INTRODUCTION: Linezolid was approved for clinical use for methicillin resistant Staphylococcus aureus and vancomycin-resistant Enterococci. Additionally it is used in the management of drug resistant tuberculosis. It is well-tolerated however bone marrow suppression and neuropathies may occur in patients taking this antibiotic for more than 2 weeks. Black discoloration and black hairy tongue (BHT) due to linezolid is rarely reported. We report two cases of BHT. CASE REPORTS: Two patients of drug resistant pulmonary tuberculosis developed benign hairy tongue with linezolid 600mg per day...
January 2017: Indian Journal of Tuberculosis
https://www.readbyqxmd.com/read/28157809/withdrawal-assessment-tool-1-monitoring-in-picu-a-multicenter-study-on-iatrogenic-withdrawal-syndrome
#20
Angela Amigoni, Maria Cristina Mondardini, Ilaria Vittadello, Federico Zaglia, Emanuele Rossetti, Francesca Vitale, Stefania Ferrario, Fabio Savron, Giancarlo Coffaro, Luca Brugnaro, Roberta Amato, Andrea Wolfler, Linda S Franck
OBJECTIVES: Withdrawal syndrome is an adverse reaction of analgesic and sedative therapy, with a reported occurrence rate between 17% and 57% in critically ill children. Although some factors related to the development of withdrawal syndrome have been identified, there is weak evidence for the effectiveness of preventive and therapeutic strategies. The main aim of this study was to evaluate the frequency of withdrawal syndrome in Italian PICUs, using a validated instrument. We also analyzed differences in patient characteristics, analgesic and sedative treatment, and patients' outcome between patients with and without withdrawal syndrome...
February 2017: Pediatric Critical Care Medicine
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