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adverse drug withdrawal reactions

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https://www.readbyqxmd.com/read/28691251/postmarketing-withdrawal-of-human-medicinal-products-because-of-adverse-reactions-in-animals-a-systematic-review-and-analysis
#1
Igho J Onakpoya, Carl J Heneghan, Jeffrey K Aronson
PURPOSE: We have identified human medicinal products for which animal data were used as evidence for withdrawal, determined whether the adverse reactions were reported in humans, established whether confirmatory human studies were conducted, and explored the withdrawal patterns over time. METHODS: We searched the World Health Organization's Consolidated List of [Medicinal] Products, drug regulatory authorities' websites, PubMed, Google Scholar, and selected textbooks to identify medicinal products withdrawn from 1950 to June 2016...
July 9, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28664354/impact-of-medicine-withdrawal-on-reporting-of-adverse-events-involving-therapeutic-alternatives-a-study-from-the-french-spontaneous-reporting-database
#2
Cécile Pageot, Julien Bezin, Andy Smith, Mickael Arnaud, Francesco Salvo, Françoise Haramburu, Bernard Bégaud, Antoine Pariente
INTRODUCTION: The consequences of the withdrawal of marketing authorisation of drugs have mostly been studied considering drug prescription patterns for the therapeutic alternatives of the withdrawn drugs. The potential concomitant changes in the reporting of adverse reactions concerning these alternatives have been studied less often. OBJECTIVE: The objective of this study was to analyse the changes in the reporting of adverse events (AEs) for therapeutic alternatives after the withdrawal of three medicines (dextropropoxyphene, pioglitazone and tetrazepam) from the market for safety reasons...
June 29, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28640208/associations-of-drug-lipophilicity-and-extent-of-metabolism-with-drug-induced-liver-injury
#3
Kristin McEuen, Jürgen Borlak, Weida Tong, Minjun Chen
Drug-induced liver injury (DILI), although rare, is a frequent cause of adverse drug reactions resulting in warnings and withdrawals of numerous medications. Despite the research community's best efforts, current testing strategies aimed at identifying hepatotoxic drugs prior to human trials are not sufficiently powered to predict the complex mechanisms leading to DILI. In our previous studies, we demonstrated lipophilicity and dose to be associated with increased DILI risk and, and in our latest work, we factored reactive metabolites into the algorithm to predict DILI...
June 22, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28627373/development-and-application-of-a-population-physiologically-based-pharmacokinetic-model-for-penicillin-g-in-swine-and-cattle-for-food-safety-assessment
#4
Miao Li, Ronette Gehring, Jim E Riviere, Zhoumeng Lin
Penicillin G is a widely used antimicrobial in food-producing animals, and one of the most predominant drug residues in animal-derived food products. Due to reduced sensitivity of bacteria to penicillin, extralabel use of penicillin G is common, which may lead to violative residues in edible tissues and cause adverse reactions in consumers. This study aimed to develop a physiologically based pharmacokinetic (PBPK) model to predict drug residues in edible tissues and estimate extended withdrawal intervals for penicillin G in swine and cattle...
June 13, 2017: Food and Chemical Toxicology
https://www.readbyqxmd.com/read/28625146/cephalosporins-associated-pseudomembranous-colitis-in-an-elderly-male-patient-a-case-report
#5
Prashant Maheshbhai Parmar, Vipul V Solanki, Manish J Barvaliya, Bhavesh Chavada, C B Tripathi
A 78 year old male patient developed pseudomembranous colitis after administration of Ceftriaxone and Cefazolin for the treatment of pleural effusion. The reaction was confirmed by Ultrasonography and CT scan. Causative agents were stopped and patient was managed by systemic therapy. Patient was expired due to respiratory complications as there was complexity in management of disease due to development of pseudomembranous colitis. Increase awareness of prescribers for high-risk drugs, close monitoring, with immediate withdrawal of the culprit drug can reduce the complexity of management which occurred due to development of such adverse drug reaction...
June 15, 2017: Current Drug Safety
https://www.readbyqxmd.com/read/28616438/drug-reaction-with-eosinophilia-and-systemic-symptom-in-a-patient-with-pneumonia-and-hyperthyroidism
#6
Hualiang Jin, Limin Wang, Jian Ye
Drug rash with eosinophilia and systemic symptoms syndrome is an idiosyncratic drug reaction characterized by fever, skin eruption, lymph node enlargement, and internal organ involvement. We report a case of a patient with pneumonia who developed clinical manifestations of fever, rash, lymphadenopathy, hypereosinophilia, and visceral involvement (renal failure and eosinophilic pneumonitis) caused by methimazole. The patient improved remarkably with drug withdrawal. A high index of clinical suspicion is emphasized to facilitate prompt diagnosis of medication-related adverse effect and its discontinuation...
April 2017: Journal of Research in Pharmacy Practice
https://www.readbyqxmd.com/read/28603098/comparison-of-efficacy-of-folic-acid-and-silymarin-in-the-management-of-antiepileptic-drug-induced-liver-injury-a-randomized-clinical-trial
#7
Masoumeh Asgarshirazi, Mamak Shariat, Mahdi Sheikh
BACKGROUND: Liver injury associated with antiepileptic drugs accounts for a large proportion of drug-induced liver injuries (DILI) in children. Although withdrawal of the causative agent is the only proved treatment for DILI, in some clinical situations it is not possible. Recent studies have reported promising results of using hepatoprotective drugs with antioxidant actions for the management of DILI. This study aimed to evaluate the efficacy of folic acid versus silymarin treatment in relation to decreasing liver enzymes in patients with DILI due to antiepileptic therapy...
June 2017: Hepatobiliary & Pancreatic Diseases International: HBPD INT
https://www.readbyqxmd.com/read/28546090/safety-and-tolerability-of-long-acting-cabotegravir-injections-in-hiv-uninfected-men-eclair-a-multicentre-double-blind-randomised-placebo-controlled-phase-2a-trial
#8
Martin Markowitz, Ian Frank, Robert M Grant, Kenneth H Mayer, Richard Elion, Deborah Goldstein, Chester Fisher, Magdalena E Sobieszczyk, Joel E Gallant, Hong Van Tieu, Winkler Weinberg, David A Margolis, Krischan J Hudson, Britt S Stancil, Susan L Ford, Parul Patel, Elizabeth Gould, Alex R Rinehart, Kimberly Y Smith, William R Spreen
BACKGROUND: Cabotegravir (GSK1265744) is an HIV-1 integrase strand transfer inhibitor with potent antiviral activity and a long half-life when administered by injection that prevented simian-HIV infection upon repeat intrarectal challenge in male macaques. We aimed to assess the safety, tolerability, and pharmacokinetics of long-acting cabotegravir injections in healthy men not at high risk of HIV-1 infection. METHODS: We did this multicentre, double-blind, randomised, placebo-controlled, phase 2a trial at ten sites in the USA...
May 22, 2017: Lancet HIV
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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