DOCSLIB.ORG

A Meta-Analysis of Salvage Therapy for Pneumocystis Carinii Pneumonia

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
A Meta-Analysis of Salvage Therapy for Pneumocystis Carinii Pneumonia ORIGINAL INVESTIGATION A Meta-analysis of Salvage Therapy for Pneumocystis carinii Pneumonia Raymond A. Smego, Jr, MD, MPH, DTM&H; Shashi Nagar, BSc; Bonnie Maloba, MBBCh; Mirjana Popara, MBBCh Objective: To determine the relative efficacies of alter- (63 patients), trimethoprim-sulfamethoxazole and/or native antipneumocystis agents in human immunodefi- pentamidine (258 patients), aerosolized pentamidine (6 ciency virus (HIV)–infected patients with Pneumocystis patients), atovaquone (3 patients), dapsone (3 pa- carinii pneumonia unresponsive to primary drug treat- tients), a combination product of trimethoprim and dap- ment with a combination product of trimethoprim and sone (2 patients), and trimethoprim-sulfamethoxazole fol- sulfamethoxazole or parenteral pentamidine. lowed by a combination of clindamycin and primaquine phosphate (2 patients). Efficacies of salvage regimens were Methods: Meta-analysis of 27 published clinical drug tri- as follows: clindamycin-primaquine (42 to 44 [88%- als, case series, and case reports involving P carinii pneu- 92%] of 48 patients; P,10−8), atovaquone (4 [80%] of monia. Data extracted included underlying disease, pri- 5), eflornithine hydrochloride (40 [57%] of 70; P,.01), mary antipneumocystis treatment, days of failed primary trimethoprim-sulfamethoxazole (27 [53%] of 51; P,.08), treatment, salvage regimen, use of systemic corticoste- pentamidine (64 [39%] of 164), and trimetrexate (47 roids and antiretroviral drugs, and clinical outcome. [30%] of 159). Results: In 497 patients with microbiologically con- Conclusion: The combination of clindamycin plus pri- firmed P carinii pneumonia (456 with HIV or acquired maquine appears to be the most effective alternative treat- immunodeficiency syndrome), initial antipneumocys- ment for patients with P carinii pneumonia who are un- tis treatment failed and they therefore required alterna- responsive to conventional antipneumocystis agents. tive drug therapy. Failed regimens included trimethoprim- sulfamethoxazole (160 patients), intravenous pentamidine Arch Intern Med. 2001;161:1529-1533 OR PATIENTS with Pneumo- efficacy of “salvage” therapy for patients cystis carinii pneumonia, a unresponsive to conventional treatment combination product of tri- with trimethoprim-sulfamethoxazole or methoprim and sulfa- pentamidine. Agents available for treat- methoxazole and paren- ing first-episode and unresponsive P ca- Fteral pentamidine are first-line therapeutic rinii pneumonia include trimetrexate, agents and have been shown to have com- atovaquone, and a combination of clinda- parable clinical efficacy.1-4 Trimethoprim- mycin and primaquine phosphate, but no sulfamethoxazole is considered the drug comparative trials using these drugs as sal- of choice because of its excellent tissue vage regimens have been conducted. We penetration and oral bioavailability, more conducted a literature review and meta- rapid in vivo activity, and relatively lower analysis of drug treatment studies and case cost and wide availability. Intolerance to series or reports to determine the relative both trimethoprim-sulfamethoxazole and efficacies of alternative antipneumocys- pentamidine is not uncommon, espe- tis agents in patients with unresponsive cially in patients with human immunode- P carinii pneumonia. ficiency virus/acquired immunodefi- From the Department of ciency syndrome (HIV/AIDS), and may RESULTS Clinical Microbiology and require a change in therapy in up to 50% Infectious Diseases, University 3,5 of the Witwatersrand/South to 60% of treated patients. For these in- Clinical and treatment features for pa- African Institute for Medical dividuals, substitution of pentamidine for tients treated with salvage drug regimens Research, and the Sizwe trimethoprim-sulfamethoxazole or vice for P carinii pneumonia are shown in Tropical Diseases Hospital, versa is generally effective.2,6 However, Table 1. Four hundred ninety-seven pa- Johannesburg, South Africa. there is a paucity of published data on the tients were identified in our systematic lit- (REPRINTED) ARCH INTERN MED/ VOL 161, JUNE 25, 2001 WWW.ARCHINTERNMED.COM 1529 ©2001 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 10/01/2021 PATIENTS AND METHODS blood pressure, and respiratory rate) with a requirement for increased FIO2. Four studies (with a total of 51 pa- tients) were also included in the analysis even though a pre- From January 1975 through August 1999, a comprehen- cise duration of initial antipneumocystis treatment was not sive analysis of the English-language literature was con- given; these included a National Institutes of Health study ducted on the basis of a MEDLINE computerized search, pe- (37 patients) and a Centers for Disease Control multi- rusal of Index Medicus and Current Contents, and review of center trial (14 patients). bibliographies of articles and major infectious diseases text- In the studies reviewed, a positive response to sal- books to identify clinical trials or case series or reports in vage treatment was variably defined but included 1 of the which alternative agents were used for patients with P cari- following: (1) amelioration or resolution of baseline signs nii pneumonia and conventional treatment failure. Key words and symptoms (eg, fever, cough, dyspnea, pulse, and res- included P carinii, HIV/AIDS, salvage therapy, trimethoprim- piratory rate), chest radiograph, and arterial blood gases; sulfamethoxazole, pentamidine, trimetrexate, atovaquone, and (2) sustained clinical improvement for at least 2 to 4 weeks clindamycin-primaquine. Twenty-seven clinical studies were after cessation of antipneumocystis therapy with no alter- identified that reported sufficient details of drug treatment nate treatment given during that time; (3) patient dis- failure and alternative therapy for P carinii pneumonia, in- charged alive from the hospital; or (4) patient alive 30 days cluding clinical outcome, and were included in this review. after confirmation of the diagnosis. Salvage therapy was con- Only cases of pneumonia that were microbiologically con- sidered a failure when the above criteria for positive re- firmed by lung biopsy, bronchoalveolar lavage, or sputum sponse were not met. smear to be due to P carinii infection were included in the Systemic corticosteroids were not administered with analysis. Data extracted included underlying disease, pri- salvage agents for most study patients. Six studies indi- mary antipneumocystis treatment, days of failed primary treat- cated that steroids had been used for some patients (a maxi- ment, salvage regimen, use of systemic corticosteroids and mum of 38 patients, or 7.6% of the study cohort) with mod- antiretroviral drugs, and clinical outcome. erately severe P carinii pneumonia, usually at the discretion Failure of primary antipneumocystis treatment was of the attending physician, but few details were given. There generally defined as clinical deterioration occurring dur- were no statistically significant differences in the inci- ing the first 4 to 5 days of therapy or lack of improvement dences of adjuvant corticosteroid or antiretroviral drug use in the patient’s condition after 7 or more days of treat- between the salvage regimens examined. ment. We included patients from 3 studies in which pa- Statistical interpretation of data was performed using tients were switched to alternate drug therapy after only 3 a computer software package (Epi Info; Centers for Dis- or more days of treatment because of the stringent criteria ease Control and Prevention, Atlanta, Ga) and the x2 test that were used: (1) progressive clinical deterioration as dem- with Yates correction factor or Fisher exact test, as appro- onstrated by the inability to maintain a stable arterial PaO2 priate. For all tests, P,.05 was considered statistically sig- despite an increase in the fraction of inspired oxygen (FIO2), nificant. Confidence intervals were determined assuming and (2) progressive deterioration of vital signs (pulse rate, a binomial distribution of values. erature review and included in the data analysis. Most COMMENT patients were adults (467 of 497 patients). In the study population, HIV/AIDS was the major underlying dis- ease, accounting for 92% of cases treated with salvage For HIV-related P carinii pneumonia, treatment with tri- therapy. Drugs used in failed treatment regimens in- methoprim-sulfamethoxazole or parenteral pentami- cluded trimethoprim-sulfamethoxazole (160 patients), dine is effective in about 75% to 95% of cases1-3,5,6,15; im- parenteral pentamidine (63 patients), inhaled pentami- provement generally occurs within 4 to 8 days of dine (6 patients), atovaquone (3 patients), dapsone (3 treatment, and some patients appear to respond within patients), a combination product of trimethoprim and dap- 24 hours. However, the optimal clinical approach for pa- sone (2 patients), and trimethoprim-sulfamethoxazole tients whose condition does not improve or continues followed by clindamycin-primaquine (2 patients). For to deteriorate despite 4 to 10 days of primary drug treat- 258 patients, failure was reported for conventional therapy ment is not certain. Switching therapy from trimethoprim- (ie, trimethoprim-sulfamethoxazole and/or pentami- sulfamethoxazole to pentamidine or vice versa or to agents dine; when patients received both drugs, they were gen- such as trimetrexate, atovaquone, or clindamycin- erally given sequentially). Duration of failed primary primaquine is typically the recommended strategy,1,3
Load more

Recommended publications
  • In Silico Methods for Drug Repositioning and Drug-Drug Interaction Prediction
    In silico Methods for Drug Repositioning and Drug-Drug Interaction Prediction Pathima Nusrath Hameed ORCID: 0000-0002-8118-9823 Submitted in total fulfilment of the requirements for the degree of Doctor of Philosophy Department of Mechanical Engineering THE UNIVERSITY OF MELBOURNE May 2018 Copyright © 2018 Pathima Nusrath Hameed All rights reserved. No part of the publication may be reproduced in any form by print, photoprint, microfilm or any other means without written permission from the author. Abstract Drug repositioning and drug-drug interaction (DDI) prediction are two fundamental ap- plications having a large impact on drug development and clinical care. Drug reposi- tioning aims to identify new uses for existing drugs. Moreover, understanding harmful DDIs is essential to enhance the effects of clinical care. Exploring both therapeutic uses and adverse effects of drugs or a pair of drugs have significant benefits in pharmacology. The use of computational methods to support drug repositioning and DDI prediction en- able improvements in the speed of drug development compared to in vivo and in vitro methods. This thesis investigates the consequences of employing a representative training sam- ple in achieving better performance for DDI classification. The Positive-Unlabeled Learn- ing method introduced in this thesis aims to employ representative positives as well as reliable negatives to train the binary classifier for inferring potential DDIs. Moreover, it explores the importance of a finer-grained similarity metric to represent the pairwise drug similarities. Drug repositioning can be approached by new indication detection. In this study, Anatomical Therapeutic Chemical (ATC) classification is used as the primary source to determine the indications/therapeutic uses of drugs for drug repositioning.
    [Show full text]
  • Treating Opportunistic Infections Among HIV-Infected Adults and Adolescents
    Morbidity and Mortality Weekly Report Recommendations and Reports December 17, 2004 / Vol. 53 / No. RR-15 Treating Opportunistic Infections Among HIV-Infected Adults and Adolescents Recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/ Infectious Diseases Society of America INSIDE: Continuing Education Examination department of health and human services Centers for Disease Control and Prevention MMWR CONTENTS The MMWR series of publications is published by the Epidemiology Program Office, Centers for Disease Introduction......................................................................... 1 Control and Prevention (CDC), U.S. Department of How To Use the Information in This Report .......................... 2 Health and Human Services, Atlanta, GA 30333. Effect of Antiretroviral Therapy on the Incidence and Management of OIs .................................................... 2 SUGGESTED CITATION Initiation of ART in the Setting of an Acute OI Centers for Disease Control and Prevention. Treating (Treatment-Naïve Patients) ................................................. 3 Management of Acute OIs in the Setting of ART .................. 4 opportunistic infections among HIV-infected adults and When To Initiate ART in the Setting of an OI ........................ 4 adolescents: recommendations from CDC, the National Special Considerations During Pregnancy ........................... 4 Institutes of Health, and the HIV Medicine Association/ Disease Specific Recommendations ....................................
    [Show full text]
  • Clindamycin with Primaquine Vs. Trimethoprim-Sulfamethoxazole
    524 Clindamycin with Primaquine vs. Trimethoprim-Sulfamethoxazole Therapy for Mild and Moderately Severe Pneumocystis carinii Pneumonia in Patients with AIDS: A Multicenter, Double-Blind, Randomized Trial (CTN 004) Emil Toma, Anona Thorne, Joel Singer, Janet Raboud, From the Department of Microbiology and Infectious Diseases, Centre Claude Lemieux, Sylvie Trottier, Michel G. Bergeron, Hospitalier de l'Universite de MontreÂal, the Immunode®ciency Chris Tsoukas, Julian Falutz, Richard Lalonde, Treatment Centre (IDTC), Montreal General Hospital, and the Royal Victoria Hospital, Montreal, and Centre Hospitalier de l'Universite du Christiane Gaudreau, Rachel Therrien, and the QueÂbec, Quebec, Quebec; and the Canadian HIV Trials Network, CTN-PCP Study Group* Vancouver, British Columbia, Canada This double-blind, randomized, multicenter trial compared clindamycin/primaquine (Cm/Prq) Downloaded from https://academic.oup.com/cid/article/27/3/524/280761 by guest on 25 September 2021 with trimethoprim-sulfamethoxazole (TMP-SMZ) as therapy for AIDS-related Pneumocystis carinii pneumonia (PCP). Forty-®ve patients received clindamycin (450 mg four times daily [q.i.d.]) and primaquine (15 mg of base/d); 42 received TMP-SMZ (320 mg/1,600 mg q.i.d. if weight of §60 kg or 240 mg/1,200 mg q.i.d. if weight of õ60 kg) plus placebo primaquine. Overall, the ef®cacy of Cm/Prq was similar to that of TMP-SMZ (success rate, 76% vs. 79%, respectively); Cm/Prq was associated with fewer adverse events (P Å .04), less steroid use (P Å .18), and more rashes (P Å .07). These differences were even greater for patients with PaO2 of ú70 mm Hg (P Å .02, P Å .04, and P Å .02, respectively).
    [Show full text]
  • Integrating Functional GI Observations Into Toxicology Studies
    Safety Pharmacology Society Webinar Series: Safety Pharmacology Endpoints: Integration into Toxicology Studies Integrating functional GI observations into toxicology studies Jean-Pierre Valentin, PhD Louise Marks, PhD Drug Safety & Metabolism Translational Safety Alderley Park, Cheshire United Kingdom [email protected] Aims of presentation • Highlight the scope of the problem surrounding GI adverse effects in preclinical and clinical development • Present an overview of the GI system and types of GI adverse effects • Highlight current Regulatory Guidance for assessing GI liability • Discuss what we can do to help to investigate this liability more thoroughly • Summarise the available methods for assessing drug-induced changes to GI function • Describe 3 methods amenable to inclusion on toxicology studies • Describe 4 real life examples of where GI endpoints have been used • Conclusion and discussion ImpactImpact of of adverse adverse effects effects of drugs of by organdrugs function by organthroughout function the pharmaceutical throughout life cycle the pharmaceutical life cycle Phase ‘Nonclinical’ Phase I Phase I-III Phase III/ Post- Post- Marketing Marketing Marketing Information: Causes of Serious ADRs Causes of ADRs on label Serious ADRs Withdrawal from attrition attrition sale Source: Car (2006) Sibille et al. Olson et al. BioPrint® (2006) Budnitz et al. Stevens & Baker (1998) (2000) (2006) (2008) Sample size: 88 CDs stopped 1,015 subjects 82 CDs stopped 1,138 drugs 21,298 patients 47 drugs Cardiovascular:
    [Show full text]
  • DHFR Inhibitors: Reading the Past for Discovering Novel Anticancer Agents
    molecules Review DHFR Inhibitors: Reading the Past for Discovering Novel Anticancer Agents Maria Valeria Raimondi 1,*,† , Ornella Randazzo 1,†, Mery La Franca 1 , Giampaolo Barone 1 , Elisa Vignoni 2, Daniela Rossi 2 and Simona Collina 2,* 1 Department of Biological, Chemical and Pharmaceutical Sciences and Technologies (STEBICEF), University of Palermo, via Archirafi 32, 90123 Palermo, Italy; [email protected] (O.R.); [email protected] (M.L.F.); [email protected] (G.B.) 2 Drug Sciences Department, Medicinal Chemistry and Pharmaceutical Technology Section, University of Pavia, via Taramelli 12, 27100 Pavia, Italy; [email protected] (E.V.); [email protected] (D.R.) * Correspondence: [email protected] (M.V.R.); [email protected] (S.C.); Tel.: +390-912-389-1915 (M.V.R.); +390-382-987-379 (S.C.) † These Authors contributed equally to this work. Academic Editors: Simona Collina and Mariarosaria Miloso Received: 25 February 2019; Accepted: 20 March 2019; Published: 22 March 2019 Abstract: Dihydrofolate reductase inhibitors are an important class of drugs, as evidenced by their use as antibacterial, antimalarial, antifungal, and anticancer agents. Progress in understanding the biochemical basis of mechanisms responsible for enzyme selectivity and antiproliferative effects has renewed the interest in antifolates for cancer chemotherapy and prompted the medicinal chemistry community to develop novel and selective human DHFR inhibitors, thus leading to a new generation of DHFR inhibitors. This work summarizes the mechanism of action, chemical, and anticancer profile of the DHFR inhibitors discovered in the last six years. New strategies in DHFR drug discovery are also provided, in order to thoroughly delineate the current landscape for medicinal chemists interested in furthering this study in the anticancer field.
    [Show full text]
  • Pharmaceuticals As Environmental Contaminants
    PharmaceuticalsPharmaceuticals asas EnvironmentalEnvironmental Contaminants:Contaminants: anan OverviewOverview ofof thethe ScienceScience Christian G. Daughton, Ph.D. Chief, Environmental Chemistry Branch Environmental Sciences Division National Exposure Research Laboratory Office of Research and Development Environmental Protection Agency Las Vegas, Nevada 89119 [email protected] Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada Why and how do drugs contaminate the environment? What might it all mean? How do we prevent it? Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada This talk presents only a cursory overview of some of the many science issues surrounding the topic of pharmaceuticals as environmental contaminants Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada A Clarification We sometimes loosely (but incorrectly) refer to drugs, medicines, medications, or pharmaceuticals as being the substances that contaminant the environment. The actual environmental contaminants, however, are the active pharmaceutical ingredients – APIs. These terms are all often used interchangeably Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada Office of Research and Development Available: http://www.epa.gov/nerlesd1/chemistry/pharma/image/drawing.pdfNational
    [Show full text]
  • Immunohistochemical Analysis of P-Glycoprotein Expression in Breast Cancer: Clinical Correlations*
    ANNALS OF CLINICAL AND LABORATORY SCIENCE, Vol. 25, No. 1 Copyright © 1995, Institute for Clinical Science, Inc. Immunohistochemical Analysis of P-glycoprotein Expression in Breast Cancer: Clinical Correlations* DAVID A. DECKER, M.D.,t LAURA W. MORRIS, B.S.,$ ALLAN J. LEVINE, M.D.,§ JANE E. PETTINGA, M.D . , 11 JENNIPHER L. GRUDZIEN, B.S.,f and DANIEL H. FARKAS, Ph.D.** Departments of Medicine,t Anatomic Pathology,t and Clinical Pathology,§ William Beaumont Hospital, Royal Oak, MI 48073 and Department of Biology, Oakland University,l! Rochester, MI 48309 and Department of Surgery, William Beaumont Hospital-Troy,U Troy, MI 48098 and Bio-Oncology Laboratory,** Pontiac, MI 48057 ABSTRACT Paraffin-embedded, formalin-fixed tissue (PEFFT) specimens from a subset of breast cancer patients were analyzed by immunohistochemistry to determine whether or not the presence of P-glycoprotein identified che­ motherapy resistance. Two antibodies, C219 (monoclonal) and Abl (poly­ clonal), demonstrated appropriate immunostaining. Retrospectively and prospectively, P-glycoprotein expression was determined from PEFFT of 20 breast cancer biopsies (19 patients with locally advanced or metastatic disease). Immunohistochemical staining was graded for number of positive cells (NO to N4) and intensity (10 to 13). The immunostaining N and I of both antibodies were similar. There was no correlation between N, (P = 0.13) or I, (P = 0.67) and chemotherapy response or between N, (P = 0.63) or I, (P = 0.89) and survival. Five patients had residual cancer at repeat biopsy after systemic chemotherapy for locally advanced disease. These specimens had similar N and I as the primary cancer. This assay accurately identifies P-glycoprotein expression in PEFFT and revealed no correlation between expression and chemotherapy response or survival.
    [Show full text]
  • Sexually Transmitted Diseases Treatment Guidelines, 2010
    Morbidity and Mortality Weekly Report www.cdc.gov/mmwr Recommendations and Reports December 17, 2010 / Vol. 59 / No. RR-12 Sexually Transmitted Diseases Treatment Guidelines, 2010 department of health and human services Centers for Disease Control and Prevention MMWR CONTENTS The MMWR series of publications is published by the Office of Surveillance, Epidemiology, and Laboratory Services, Centers for Introduction .............................................................................. 1 Disease Control and Prevention (CDC), U.S. Department of Health Methods ................................................................................... 1 and Human Services, Atlanta, GA 30333. Clinical Prevention Guidance ..................................................... 2 STD/HIV Prevention Counseling ............................................... 2 Suggested Citation: Centers for Disease Control and Prevention. [Title]. MMWR 2010;59(No. RR-#):[inclusive page numbers]. Prevention Methods ................................................................ 4 Partner Management .............................................................. 7 Centers for Disease Control and Prevention Reporting and Confidentiality .................................................. 8 Thomas R. Frieden, MD, MPH Special Populations ................................................................... 8 Director Pregnant Women ................................................................... 8 Harold W. Jaffe, MD, MA Adolescents .........................................................................
    [Show full text]
  • 212-253-8881 Immtech and Par
    One North End Avenue Suite 1111 New York New York 10282 Telephone: (877) 898-8038 (212) 791-2911 Fax: 212-791-2917 (Amex-IMM) CONTACT: Paul Hendley - 212-253-8881 IMMTECH AND PAR ENTER LICENSING AGREEMENT ON PAFURAMIDINE FOR TREATMENT OF PNEUMOCYSTIS PNEUMONIA IN THE U.S. PCP Most Common Opportunistic Infection in People with HIV New York, NY, June 12, 2007 – Immtech Pharmaceuticals, Inc. (AMEX: IMM) announced today that Immtech has granted an exclusive license to Par Pharmaceutical Companies, Inc. (NYSE: PRX) to commercialize Immtech’s lead oral drug, pafuramidine maleate, in the United States for the treatment of pneumocystis pneumonia (PCP) in AIDS patients. Immtech and Par may also collaborate on efforts to develop pafuramidine as a preventative therapy for patients at risk of developing PCP, including people living with HIV, cancer and other immunosuppressive conditions. According to the terms of the signed agreement, Immtech has received an initial payment of $3 million from Par. An additional $29 million will be paid to Immtech as pafuramidine advances through ongoing Phase III clinical trials and U.S. regulatory review and approval. Immtech will receive royalties on sales. In addition to royalties, Immtech could also receive up to $115 million in additional payments based on sales milestones. Immtech retains the right to co-market pafuramidine in the U.S. “We are delighted to be collaborating with Par to launch pafuramidine,” said Daniel M. Schmitt, Vice President, Licensing and Commercial Development at Immtech. “Par’s recent success with commercializing Megace ES® for AIDS wasting disease demonstrates their clear understanding of the needs of both patients and healthcare providers focused on the treatment of HIV/AIDS.
    [Show full text]
  • BLACK BOX WARNINGS of ANTIBIOTICS: a NARRATIVE REVIEW 1Nehad J
    IAJPS 2019, 06 (05), 9054-9058 Nehad J. Ahmad ISSN 2349-7750 CODEN [USA]: IAJPBB ISSN: 2349-7750 INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES http://doi.org/10.5281/zenodo.2672035 Available online at: http://www.iajps.com Review Article BLACK BOX WARNINGS OF ANTIBIOTICS: A NARRATIVE REVIEW 1Nehad J. Ahmad 1 Department of Clinical Pharmacy, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.Nehad Jaser Ahmad , [email protected] Article Received: March 2019 Accepted: April 2019 Published: May 2019 Key Points: • Boxed Warning is important to call attention to serious or life-threatening risks. • The physician should decide whether to prescribe a drug with a boxed warning for the patient or no • Black box warnings for Antibiotics are mainly for Aminoglycosides and Fluoroquinolones Corresponding author: Nehad J. Ahmad, QR code Department of Clinical Pharmacy, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.Nehad Jaser Ahmad, [email protected]. Please cite this article in press Nehad J. Ahmad ., Black Box Warnings Of Antibiotics: A Narrative Review., Indo Am. J. P. Sci, 2019; 06(05). www.iajps.com Page 9054 IAJPS 2019, 06 (05), 9054-9058 Nehad J. Ahmad ISSN 2349-7750 INTRODUCTION: reactions (11). O'Connor, NR reported that many Boxed warning, commonly referred to as a “black medications such as fluoquinolones , salmetrol and box warning”, appears on the labeling of drugs and is oral sodium phosphate bowel preparation remain important to call attention to serious or life- available treatment despite the black box warning of threatening risks.(1) The Boxed Warning is a risk these medications, so it is the responsibility of mitigation , These warnings typically concern physicians to decide whether to use these drugs or no important safety issues with a potential for main (12) another study also showed the severe adverse effect on public health.
    [Show full text]
  • Stembook 2018.Pdf
    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]
  • Final1-Aritmo-Final-Report-V2-0Final.Pdf
    ARITMO Final Report PROJECT FINAL REPORT Grant Agreement number: 241679 Project acronym: ARITMO Project title: Arrhythmogenic potential of drugs Funding Scheme: Small or Medium-Scale Focused Research Project Period covered: from 1st January 2010 to 30th June 2013 Name of the scientific representative of the project's co-ordinator, Title and Organisation: Prof. Miriam CJM Sturkenboom, Erasmus Universitair Medisch Centrum Rotterdam Tel: +31 10 704 4126 Fax: +31 10 704 4722 E-mail: [email protected] Project website1 address: www.aritmo-project.org 1 The home page of the website should contain the generic European flag and the FP7 logo which are available in electronic format at the Europa website (logo of the European flag: http://europa.eu/abc/symbols/emblem/index_en.htm ; logo of the 7th FP: http://ec.europa.eu/research/fp7/index_en.cfm?pg=logos). The area of activity of the project should also be mentioned. © Copyright 2013 ARITMO Consortium 1 ARITMO Final Report Table of contents Table of contents ................................................................................................................................................................. 2 1. Final publishable summary report ................................................................................................................................ 3 1.1 Executive summary ................................................................................................................................................. 3 1.2 Description of project context and
    [Show full text]