DOCSLIB.ORG

Prevention, Diagnosis, and Management of Infection in Dogs

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Prevention, Diagnosis, and Management of Infection in Dogs Current Canine Guidelines for the Prevention, Diagnosis, and Management of Heartworm (Dirofilaria immitis) Infection in Dogs Thank You to Our Generous Sponsors: Printed with an Education Grant from IDEXX Laboratories. Photomicrographs courtesy of Bayer HealthCare. © 2014 American Heartworm Society | PO Box 8266 | Wilmington, DE 19803-8266 | E-mail: [email protected] Current Canine Guidelines for the Prevention, Diagnosis, and Management of Heartworm (Dirofilaria immitis) Infection in Dogs (revised July 2014) CONTENTS Click on the links below to navigate to each section. Preamble .....................................................................................................................................................................3 HIGHLIGHTS ................................................................................................................................................................3 EPIDEMIOLOGY ..........................................................................................................................................................3 Figure 1. Urban heat island profile. BIOLOGY AND LIFE CYCLE ........................................................................................................................................5 Figure 2. The heartworm life cycle. HEARTWORM PREVENTION .....................................................................................................................................6 Macrocyclic Lactones Drugs and Other Substances that Inhibit P-Glycoproteins (box) Reports of Lack of Efficacy PRIMARY DIAGNOSTIC SCREENING ......................................................................................................................10 Test Timing for Optimal Results Microfilaria and Antigen Testing Antigen Tests Microfilaria Tests Figure 3. Acanthocheilonema reconditum and Dirofilaria immitis. Testing Considerations Following Noncompliance and When Changing Products Figure 4. The testing protocol following known noncompliance includes three tests in the first year, with annual testing thereafter. OTHER DIAGNOSTIC AIDS ......................................................................................................................................12 Radiography Figure 5. Moderate heartworm disease (radiographs). Figure 6. Severe heartworm disease (radiographs). Echocardiography Figure 7. Echocardiogram. PRE-ADULTICIDE EVALUATION ..............................................................................................................................12 2014 Canine Heartworm Guidelines 1 PRINCIPLES OF TREATMENT ..................................................................................................................................14 Table 1. Summary of Clinical Signs of Canine Heartworm Disease ADULTICIDE THERAPY .............................................................................................................................................15 Melarsomine Dihydrochloride Pulmonary Thromboembolism ADJUNCT THERAPY .................................................................................................................................................15 Steroids NSAIDs and Aspirin Doxycycline Figure 8. Pulmonary pathology associated with death of heartworms. Macrocyclic Lactones Figure 9. Timeline of D immitis development, showing periods of susceptibility to macrocyclic lactones and melarsomine. Macrocyclic Lactones/Doxycycline AHS-RECOMMENDED PROTOCOL .........................................................................................................................18 Table 2. AHS-Recommended Protocol SURGICAL EXTRACTION OF ADULT HEARTWORMS ...........................................................................................18 Caval Syndrome (Dirofilarial Hemoglobinuria) Figure 10. Echocardiogram images. Figure 11. Surgical removal of worms. Pulmonary Arterial Infections ALTERNATIVE THERAPIES .......................................................................................................................................20 Long-term Macrocyclic Lactone Administration Herbal Therapies CONFIRMATION OF ADULTICIDE EFFICACY ..........................................................................................................20 ELIMINATION OF MICROFILARIAE .........................................................................................................................21 ELECTIVE SURGERIES IN DOGS WITH HEARTWORMS .......................................................................................21 REFERENCES ............................................................................................................................................................21 2 American Heartworm Society Prepared by Dr. C. Thomas Nelson, Dr. John W. Any method utilizing only macrocyclic lactones as McCall, and Dr. Doug Carithers (Editor), and a slow-kill adulticide is not recommended. approved by the Executive Board of the American EPIDEMIOLOGY Heartworm Society (Officers: Dr. Stephen Jones, President; Dr. Wallace Graham, Past President; Dr. Heartworm infection in dogs has been diagnosed Cristiano von Simson, Vice President; Dr. Robert around the globe, including all 50 of the United Stannard, Secretary-Treasurer; Dr. Doug Carithers, States. In the United States, its territories, and Editor; Dr. Patricia Payne, Dr. Chris Rehm, Dr. Charles protectorates, heartworm is considered at least Thomas Nelson, Dr. Martha Smith-Blackmore, Dr. regionally endemic in each of the contiguous 48 Elizabeth Clyde, and Dr. Bianca Zaffarano, Board states, Hawaii, Puerto Rico, U.S. Virgin Islands, Members; Dr. Matthew Miller, Symposium Chair; and Guam (Bowman et al, 2009; Kozek et al, 1995; Dr. Clarke Atkins, Symposium Co-Chair; Dr. John Ludlam et al, 1970). Heartworm transmission has McCall, Co-Editor; Dr. Mike Loenser and Dr. Tony not been documented in Alaska; however, there are Rumschlag, Ex Officio Members. regions in central Alaska that have mosquito vectors and climate conditions to support the transmission References added October 2015 by Christopher of heartworms for brief periods (Darsie and Ward, Evans, MS, Research Professional II, Department of 2005; Slocombe et al, 1995; Terrell, 1998). Thus, Infectious Diseases, College of Veterinary Medicine, the introduction of microfilaremic dogs or wild University of Georgia. canids could set up a nidus of infection for local Preamble transmission of heartworm in this state. Such relocation of microfilaremic dogs and expansion of These recommendations supersede previous the territories of microfilaremic wild canids in other editions and are based on the latest information areas of the United States continue to be important presented at the 2013 Triennial Symposium of factors contributing to further dissemination of the the American Heartworm Society (AHS), new parasite, as the ubiquitous presence of one or more research, and additional clinical experience. The species of vector-competent mosquitoes makes recommendations for the prevention, diagnosis, transmission possible wherever a reservoir of and management of heartworm infection in cats infection and favorable climatic conditions co-exist. are contained in a companion feline document Change in any of these factors can have a significant (http://heartwormsociety.org/veterinary-resources/ effect on the transmission potential in a specific feline-guidelines.html). geographic location. HIGHLIGHTS Environmental changes, both natural climatic • Diagnostics: AHS recommends annual change and those created by humans, and animal antigen and microfilaria testing. (Because the movement have increased heartworm infection interpretation of diagnostics has become more potential. Commercial and residential real estate complex, please see the “Microfilaria and Antigen development of non-endemic areas and areas of Testing” section for more complete information.) low incidence has led to the resultant spread and increased prevalence of heartworms by altering Chemoprophylaxis: AHS recommends year- • drainage of undeveloped land and by providing round administration of chemoprophylactic water sources in new urban homesites. In the drugs to prevent heartworm disease, control western United States, irrigation and planting of other pathogenic and/or zoonotic parasites, and trees has expanded the habitat for Aedes sierrensis enhance compliance, the latter being particularly (western knot hole mosquito), the primary vector for important in light of the documented presence of transmission of heartworms in those states (Scoles resistant subpopulations. et al, 1993). • Adulticide therapy: AHS recommends use of doxycycline and a macrocyclic lactone prior to the Aedes albopictus (Asian tiger mosquito), which three-dose regimen of melarsomine (one injection was introduced into the Port of Houston in 1985, of 2.5 mg/kg body weight followed at least one has now spread northward, approaching Canada, month later by two injections of the same dose 24 and isolated populations have been identified in hours apart) for treatment of heartworm disease areas in the western states (Scoles and Dickson, in both symptomatic and asymptomatic dogs. 1995). This urban-dwelling mosquito is able to reproduce in small containers, such as flowerpots 2014 Canine Heartworm Guidelines 3 Figure 1. Sketch of an urban heat island profile. From http://eetd.lbl.gov/HeatIsland/HighTemps/ (Benedict et al, 2007). Urban sprawl has led to the heartworm transmission in
Load more

Recommended publications
  • (12) United States Patent (10) Patent No.: US 8,227,427 B2 Coracci Neto Et Al
    USOO8227427B2 (12) United States Patent (10) Patent No.: US 8,227,427 B2 Coracci Neto et al. (45) Date of Patent: Jul. 24, 2012 (54) VETERINARIAN COMPOSITION (52) US. Cl. ........................................ .. 514/27; 514/368 COMPRISING AN ORGANIC SALT 0F (58) Field of Classi?cation Search ................. .. 513/71; LEVAMISOLE IN COMBINATION WITH AT 548/155; 514/27, 368 LEAST ONE AVERMECTIN AND/OR See application ?le for complete search history. MILBEMYCIN (75) Inventors: Dolivar Coracci Neto, Sertaozinho (56) References Cited (BR); Nelson Henriques Fernandes Filho, Jaboticabal (BR); Ricardo da FOREIGN PATENT DOCUMENTS Silva Sercheli, Jaboticabal (BR) BR PI0505716 A 9/2007 GB 2150024 A 6/1985 (73) Assignee: NPA—Nucleo de Pesquisas Aplicadas WO 00/74489 A1 12/2000 Ltda., Jaboticabal (BR) WO 2004/009080 A1 1/2004 OTHER PUBLICATIONS ( * ) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 International Search Report. U.S.C. 154(b) by 575 days. Analytical Report Characterization of Pharmaceutical Input Aurixazol (Feb. 20, 2010). (21) App1.No.: 12/097,683 Primary Examiner * Elli Peselev (22) PCT Filed: Dec. 18, 2006 (74) Attorney, Agent, or Firm * Laurence P. Colton; Smith Risley Tempel Santos LLC (86) PCT No.: PCT/BR2006/000282 § 371 (0X1)’ (57) ABSTRACT (2), (4) Date: Nov. 3, 2008 Veterinarian composition comprising an organic salt of (87) PCT Pub. No.: WO2007/068073 levamisole in combination With at least one avermectin and/ or milbemycin. A veterinarian formulation comprising of organ PCT Pub. Date: Jun. 21, 2007 ics salts of levamisole, more speci?cally to the levamisole salt of 2,6-diiodo-4-nitrophenol and the levamisole salt of 4-hy (65) Prior Publication Data droxy-3-iodo-5-nitrobenzonitrile With avermectins and mil US 2009/0075918 A1 Mar.
    [Show full text]
  • Bulletin Leading the Fight Against Heartworm Disease
    BULLETIN LEADING THE FIGHT AGAINST HEARTWORM DISEASE SEPTEMBER HEARTWORM 2017 Q&A VOLUME 44 No. 3 Heartworm History: In What Year Was Heartworm First INSIDE THIS ISSUE Treated? Page 4 From the President Page 8 Research Update Abstracts from the Literature Page 14 Heartworm Hotline: Role of Heat Treatment in Diagnostics Page 19 NEW! Best Practices: Minimizing Heartworm Transmission in Relocated Dogs uestions from members, prac- published in the 1998 AHS Symposium 1 titioners, technicians, and the Proceedings. Dr. Roncalli wrote, “The Page 21 Qgeneral public are often submit- first trial to assess the efficacy of a Welcome Our New AHS ted to the American Heartworm Society microfilaricide (natrium antimonyl tar- Student Liaisons (AHS) via our website. Two of our AHS trate) was conducted some 70 years Board members, Dr. John W.McCall and ago (1927) in Japan by S. Itagaki and R. Page 25 Dr. Tom Nelson, provided the resources Makino.2 Fuadin (stibophen), a trivalent In the News: Surgeons to answer this question: In What Year antimony compound, was tested, intra- Remove a Heartworm from Was Heartworm First Treated? venously, as a microfilaricide by Popescu the Femoral Artery of a Cat The first efforts to treat canine heart- in 1933 in Romania and by W.H. Wright worm disease date back to the 1920s. Dr. and P.C. Underwood in 1934 in the USA. Page 26 Nelson referenced a review article by Dr. In 1949, I.C. Mark evaluated its use Quarterly Update Raffaele Roncalli, “Tracing the History of intraperitoneally.” What’s New From AHS? Heartworms: A 400 Year Perspective,” Continues on page 7 American Heartworm Society / PO Box 8266, Wilmington, DE 19803-8266 Become an American Heartworm Society www.heartwormsociety.org / [email protected] fan on Facebook! Follow us on Twitter! OUR GENEROUS SPONSORS PLATINUM LEVEL PO Box 8266 Wilmington, DE 19803-8266 [email protected] www.heartwormsociety.org Mission Statement The mission of the American Heartworm Society is to lead the vet- erinary profession and the public in the understanding of heartworm disease.
    [Show full text]
  • Baylisascariasis
    Baylisascariasis Importance Baylisascaris procyonis, an intestinal nematode of raccoons, can cause severe neurological and ocular signs when its larvae migrate in humans, other mammals and birds. Although clinical cases seem to be rare in people, most reported cases have been Last Updated: December 2013 serious and difficult to treat. Severe disease has also been reported in other mammals and birds. Other species of Baylisascaris, particularly B. melis of European badgers and B. columnaris of skunks, can also cause neural and ocular larva migrans in animals, and are potential human pathogens. Etiology Baylisascariasis is caused by intestinal nematodes (family Ascarididae) in the genus Baylisascaris. The three most pathogenic species are Baylisascaris procyonis, B. melis and B. columnaris. The larvae of these three species can cause extensive damage in intermediate/paratenic hosts: they migrate extensively, continue to grow considerably within these hosts, and sometimes invade the CNS or the eye. Their larvae are very similar in appearance, which can make it very difficult to identify the causative agent in some clinical cases. Other species of Baylisascaris including B. transfuga, B. devos, B. schroeder and B. tasmaniensis may also cause larva migrans. In general, the latter organisms are smaller and tend to invade the muscles, intestines and mesentery; however, B. transfuga has been shown to cause ocular and neural larva migrans in some animals. Species Affected Raccoons (Procyon lotor) are usually the definitive hosts for B. procyonis. Other species known to serve as definitive hosts include dogs (which can be both definitive and intermediate hosts) and kinkajous. Coatimundis and ringtails, which are closely related to kinkajous, might also be able to harbor B.
    [Show full text]
  • Specifications of Approved Drug Compound Library
    Annexure-I : Specifications of Approved drug compound library The compounds should be structurally diverse, medicinally active, and cell permeable Compounds should have rich documentation with structure, Target, Activity and IC50 should be known Compounds which are supplied should have been validated by NMR and HPLC to ensure high purity Each compound should be supplied as 10mM solution in DMSO and at least 100µl of each compound should be supplied. Compounds should be supplied in screw capped vial arranged as 96 well plate format.
    [Show full text]
  • Computational Studies of Drug Repurposing Targeting P-Glycoprotein Mediated Multidrug-Resistance Phenotypes in Agents of Neglect
    bioRxiv preprint doi: https://doi.org/10.1101/2020.06.12.147926; this version posted June 12, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. Computational studies of drug repurposing targeting P- glycoprotein mediated multidrug-resistance phenotypes in agents of neglected tropical diseases Nivedita Jaishankar 1, Sangeetha Muthamilselvan 2, Ashok Palaniappan 1,2* 1 Department of Biotechnology, Sri Venkateswara College of Engineering, Post Bag No. 1, Pennalur, Sriperumbudur Tk 602117. India 2 Department of Bioinformatics, School of Chemical and BioTechnology, SASTRA Deemed University, Thanjavur 613401. India * Corresponding author: [email protected] ABSTRACT Mammalian ABCB1 P-glycoprotein is an ATP- dependent efflux pump with broad substrate specificity associated with cellular drug resistance. Homologous to this role in mammalian biology, the P-glycoprotein of agents of neglected tropical diseases (NTDs) mediates the emergence of multidrug- resistance phenotypes. The clinical and socioeconomic implications of NTDs are exacerbated by the lack of research interest among Big Pharma for treating such conditions. This work aims to characterise P-gp homologues in certain agents of key NTDs, namely (1) Protozoa: Leishmania major, Trypanosoma cruzi; (2) Helminths: Onchocerca volvulus, Schistosoma mansoni. PSI-BLAST searches against the genome of each of these organisms confirmed the presence of P-gp homologues. Each homologue was aligned against five P- gp sequences of known structure, to identify the most suitable template based on sequence homology, phylogenetic nearest neighbor, and query coverage.
    [Show full text]
  • Veterinary Guide to Resistance & Parasites
    Veterinary Guide to Resistance & Parasites How to make the Get Rotation Right deworming strategy part of your equine health wellness protocol. ||||||||||||||||||||||||||||||||||||||||| GET ROTATION RIGHT Resistant parasites – veterinary involvement is needed now. Deworming has come a long way in the past 50 years – from products that were nearly toxic and required complicated tubing to the easy-to-administer dewormers we know now. As more horse owners recognize the value of regular deworming, past troublemakers such as large strongyles have become much less of a threat. Still, deworming is nothing to take lightly. As internal parasites become more resistant, your expertise is needed Horseowners unknowingly more than ever to make sure deworming programs remain efficient contribute to resistance. and effective. Only with veterinary involvement will we control parasite • Rotating brand names, not populations, combat resistance and get rotation right. chemical classes – general confusion about when and RESISTANCE IS REAL: MULTIPLE DRUGS, MULTIPLE PARASITES. how to use different classes • No new drug class since avermectins in 1981. of dewormers. • Benzimidazole resistance in cyathostomes.1-3 • Lack of knowledge about • Pyrantel resistance in cyathostomes and ascarids.4-8,11 resistance issues. • Ivermectin and moxidectin resistance among ascarids.8,9,11 • Deworming many horses more • Early warning signs of macrocyclic-lactone-resistant cyathostomes.10 frequently than necessary. • Health-related issues caused by parasites: • Misunderstanding about the ~ Ascarids (roundworms) unique properties of larvicidal Verminous pneumonia: cough, nasal discharge, low-grade fever treatments and how to maximize Unthriftiness – rough hair coat their efficacy. Intestinal obstruction/colic • Underdosing their horses. Intestinal perforation leading to peracute death Decreased performance and reduced weight gain ~ Cyathostomes (small strongyles) Most common in young and old horses, but can afflict any horse.
    [Show full text]
  • 9Th SAVE Report
    Report of 9th Annual Meeting of Saving Asia’s Vultures from Extinction 4-6th November 2019 Pinjore, India Contents 1. About SAVE and this report 1-3 2. Updated SAVE priorities for vulture conservation in 2019 2.1 Priorities South Asia 4 2.2 Priorities South East Asia 5 3. Overview of selected SAVE activities since 8th SAVE meeting 3.1 Outstanding achievements/updates of 2019 6-8 3.2 Emerging concerns 8 3.3 The SAVE Blueprint 9 3.4 Changes regarding SAVE Partners 9 3.5 New SAVE Partners 9 3.6 Website 10 4. Progress Summary (traffic lights) for all Blueprint activities 4.1 Status in 2019 11 4.2 Status in 2018 (for comparison) 12 5. 2019 Composition of the SAVE partnership 13- 14 6. Main report: SAVE Partners 2019 updates by Country 6.1 General SAVE actions 14 6.2 India 19 6.3 Nepal 32 6.4 Bangladesh 40 6.5 Pakistan 45 6.6 Cambodia 52 6.7 Myanmar 58 7. SAVE Associates Reports 63 8. Additional Reports received relevant to SAVE Priorities from South 69 Africa 9. Additional Reports received relevant to SAVE Priorities from India 69 10. Reports received relevant to SAVE Priorities from the Middle East 74 11. Fundraising Reports 78 Annex 1. Programme of 9th Annual SAVE Meeting – Parwanoo, India 83 Annex 2. List of Meeting Attendees 86 Annex 3. Updated SAVE Blueprint for 2020 88 Annex 4. List of Acronyms and Abbreviations 108 1. About SAVE and this report The SAVE consortium, originally of eleven (now 24) organisations was formally established in February 2011 under the banner ‘Saving Asia’s Vultures from Extinction’ (SAVE).
    [Show full text]
  • From the Canadian Food Inspection Agency Annex E
    From the Canadian Food Inspection Agency http://www.inspection.gc.ca/english/fssa/meavia/man/ch17/annexee.shtml#e6 Annex E Table of Contents E.1 Introduction E.2 Equine Information Document E.3 Equine Written Description Terms E.4 Equine Lot Program E.5 List of Veterinary Dugs Not Permitted For Use in Equine Slaughtered For Food With Canadian Brand Name Examples E.6 List of "Essential" Veterinary Drugs Permitted in Equine With a 6 Month Withdrawal Period With Canadian Brand Name Examples E.7 List of Veterinary Drugs Safe for Use in Equine Intended for Food Production for Which Withdrawal Periods Have Been Determined with Canadian Brand Name Examples E.8 Frequently Asked Questions and Answers E.1 Introduction Effective July 31, 2010, it will be mandatory for all Canadian Food Inspection Agency (CFIA) inspected facilities in Canada engaged in equine slaughter for edible purposes to have complete records for all animals (domestic and imported) presented for slaughter. These records will include unique identification for each animal, a record of illness and a record of medical treatments administered to the animal for the six-month period preceding slaughter. The template entitled "Equine Information Document" (EID) of this annex (see E.2) shall be used by equine owners to provide the required information for individual equine animals. A completed individual animal EID contains a standardized description of the animal, as well as a comprehensive record of the equine's medical treatment for at least the preceding six months. The various options for identification, including visual and written descriptions, are listed in the EID.
    [Show full text]
  • WSAVA List of Essential Medicines for Cats and Dogs
    The World Small Animal Veterinary Association (WSAVA) List of Essential Medicines for Cats and Dogs Version 1; January 20th, 2020 Members of the WSAVA Therapeutic Guidelines Group (TGG) Steagall PV, Pelligand L, Page SW, Bourgeois M, Weese S, Manigot G, Dublin D, Ferreira JP, Guardabassi L © 2020 WSAVA All Rights Reserved Contents Background ................................................................................................................................... 2 Definition ...................................................................................................................................... 2 Using the List of Essential Medicines ............................................................................................ 2 Criteria for selection of essential medicines ................................................................................. 3 Anaesthetic, analgesic, sedative and emergency drugs ............................................................... 4 Antimicrobial drugs ....................................................................................................................... 7 Antibacterial and antiprotozoal drugs ....................................................................................... 7 Systemic administration ........................................................................................................ 7 Topical administration ........................................................................................................... 9 Antifungal drugs .....................................................................................................................
    [Show full text]
  • Étude De La Résistance Aux Antibiotiques Des Entérocoques D’Origine Animale Du Québec
    Université de Montréal Étude de la résistance aux antibiotiques des entérocoques d’origine animale du Québec par Cindy-Love Tremblay GREMIP et CRIP Département de pathologie et microbiologie Faculté de médecine vétérinaire Thèse présentée à la Faculté de médecine vétérinaire en vue de l’obtention du grade de philosophiae doctor (Ph.D.) en sciences vétérinaires option microbiologie Août 2012 Cindy-Love Tremblay, 2012 ii RÉSUMÉ Les entérocoques font partie de la flore normale intestinale des animaux et des humains. Plusieurs études ont démontré que les entérocoques d’origine animale pouvaient représenter un réservoir de gènes de résistance aux antibiotiques pour la communauté humaine et animale. Les espèces Enterococcus faecalis et Enterococcus faecium sont importantes en santé publique; elles sont responsables d’environ 12% de toutes les infections nosocomiales aux États-Unis. Au Canada, les cas de colonisation et/ou d’infections à entérocoques résistants à la vancomycine ont plus que triplé de 2005 à 2009. Un total de 387 isolats E. faecalis et E. faecium aviaires, et 124 isolats E. faecalis porcins ont été identifiés et analysés pour leur susceptibilité aux antibiotiques. De hauts pourcentages de résistance envers les macrolides et les tétracyclines ont été observés tant chez les isolats aviaires que porcins. Deux profils phénotypiques prédominants ont été déterminés et analysés par PCR et séquençage pour la présence de gènes de résistance aux antibiotiques. Différentes combinaisons de gènes de résistance ont été identifiées dont erm(B) et tet(M) étant les plus prévalents. Des extractions plasmidiques et des analyses par hybridation ont permis de déterminer, pour la première fois, la colocalisation des gènes erm(B) et tet(M) sur un plasmide d’environ 9 kb chez des isolats E.
    [Show full text]
  • Table of Contents Introduction
    TABLE OF CONTENTS INTRODUCTION............................................................................................................. 2 DEFINITIONS .................................................................................................................. 2 ADVERSE EVENT REPORTING FOR ANIM AL DRUGS ....................................... 4 CANINE HEARTW ORM DISEASE.............................................................................. 7 M ACROCYCLIC LACTONES ...................................................................................... 8 PROHEART 6 PRODUCT INFORM ATION ............................................................... 8 REGULATORY HISTORY OF PROHEART 6 ......................................................... 10 ADE REPORTS FOR PROHEART 6 AND OTHER HEARTW ORM PREVENTIVES .............................................................................................................. 11 PROHEART 6 ADES ..................................................................................................... 16 TRENDS IN PROHEART 6 ADE REPORTING ....................................................... 19 CLINICAL M ANIFESTATIONS ................................................................................. 22 ANAPHYLAXIS/ANAPHYLACTOID REACTIONS ................................................................ 22 CONVULSIONS ................................................................................................................ 24 LIVER SIGNS..................................................................................................................
    [Show full text]
  • 210867Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210867Orig1s000 OTHER REVIEW(S) Clinical Inspection Summary (CIS) NDA 210867 (Moxidectin) Clinical Inspection Summary Date May 31, 2018 From John Lee, M.D., Medical Officer Janice Pohlman, M.D., M.P.H., Team Leader Kassa Ayalew, M.D., M.P.H., Branch Chief Good Clinical Practice Assessment Branch (GCPAB) Division of Clinical Compliance Evaluation (DCCE) Office of Scientific Investigations (OSI) To Kristine Park, Ph.D., Regulatory Project Manager Hiwot Hiruwy, M.D., Ph.D., Medical Officer Dmitri Iarikov, M.D., Ph.D., Clinical Team Leader Sumati Nambiar, M.D., M.P.H., Director Division of Anti-Infective Products (DAIP) Application NDA 210867 Applicant Medicines Development for Global Health (MDGH) Drug Moxidectin (trade name pending) NME Yes Review Status Priority Proposed Indication Treatment of ochocerciasis due to Onchocerca volvulus Consultation Date December 15, 2017 CIS Goal Date June 1, 2018 Action Goal Date June 13, 2018 PDUFA Due Date June 13, 2018 I. OVERALL ASSESSMENT OF FINDINGS Studies 3110A1-200-GH and 3110A1-3000-AF/ONCBL60801 were audited at good clinical practice (GCP) inspections of a clinical investigator (CI) and a contract research organization (CRO). For both inspections, the establishment inspection report (EIR) has not been received from the field office and the inspection outcome shown is based on preliminary communication with the field investigator. Both inspections revealed significant GCP deficiencies, typically (apparently) deficiencies in recordkeeping (Form FDA 483 issued at CI inspection, not issued at CRO inspection). Evidence of serious deficiencies indicative of unreliable study data was not observed and study conduct otherwise appeared GCP-compliant.
    [Show full text]