RESPIRATORY TRACT RELATED INFECTIOUS SYNDROMES Acute
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Medical Review(S) Clinical Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 200327 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 200327 Priority or Standard Standard Submit Date(s) December 29, 2009 Received Date(s) December 30, 2009 PDUFA Goal Date October 30, 2010 Division / Office Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Reviewer Name(s) Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD Review Completion October 29, 2010 Date Established Name Ceftaroline fosamil for injection (Proposed) Trade Name Teflaro Therapeutic Class Cephalosporin; ß-lactams Applicant Cerexa, Inc. Forest Laboratories, Inc. Formulation(s) 400 mg/vial and 600 mg/vial Intravenous Dosing Regimen 600 mg every 12 hours by IV infusion Indication(s) Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Community-acquired Bacterial Pneumonia (CABP) Intended Population(s) Adults ≥ 18 years of age Template Version: March 6, 2009 Reference ID: 2857265 Clinical Review Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD NDA 200327: Teflaro (ceftaroline fosamil) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ......................................... 9 1.1 Recommendation on Regulatory Action ........................................................... 10 1.2 Risk Benefit Assessment.................................................................................. 10 1.3 Recommendations for Postmarketing Risk Evaluation and Mitigation Strategies ........................................................................................................................ -
Siphoning Diesel: a Fatal Mistake
CASE REPORT Siphoning diesel: a fatal mistake Leong Wei Cheng, MRCP, Brian Cheong Mun Keong, FRCP Department of Medicine, Hospital Teluk Intan cervical lymphadenopathy and auscultation of his lungs SUMMARY revealed normal findings. Examination of other systems did Diesel is commonly used as fuel for engines and is distilled not reveal any abnormalities. from petroleum. Diesel has toxic potential and can affect multiple organs. Exposure can occur after ingestion, Initial blood investigations showed evidence of acute kidney inhalation or through the dermal route. The practice of injury (urea: 16.7 mmol/l, sodium 129 mmol/l, potassium 3.7 siphoning diesel using a rubber tubing and the mouth is mmol/l and creatinine 937 µmol/l). There was presence of common in rural communities. This can lead to accidental protein and erythrocytes (2+) in his urine. His full blood count ingestion and aspiration. Here we report a case of a patient showed elevated white cell count of 11,600/µl (neutrophil who accidentally ingested diesel during siphoning, which 85%) with normal haemoglobin concentration (15.9 g/dl) caused extensive erosion of the oral cavity and oesophagus and platelets (185,000/µl). Liver transaminases were normal. leading to pneumomediastinum and severe chemical lung Chest radiograph showed clear lung fields. His provisional injury. The patient responded well initially to steroids and diagnosis was acute tonsillitis with post- infectious Rapidly supportive care but required prolonged hospitalisation. He Progressive Glomerolonephritis (RPGN). Intravenous (IV) developed complications of nosocomial infection and Ceftriaxone 2 g daily was started. succumbed 23 days after admission. He became progressively more tachypnoeic in the ward with KEY WORDS: Diesel; siphon; chemical pneumonitis; oesophageal perforation; worsening renal function and metabolic acidosis. -
Occupational Dusts Other Than Silica* by Kenneth M
Thorax: first published as 10.1136/thx.2.2.91 on 1 June 1947. Downloaded from Thorax (1947), 2, 91. DISEASES OF THE LUNG RESULTING FROM OCCUPATIONAL DUSTS OTHER THAN SILICA* BY KENNETH M. A. PERRY London It is only in recent years that considerable interest has been given to the dusts to which men are exposed at their work, even though silicosis is known to have occurred in prehistoric times. Many dusts are now recognized as dangerous, and in the extreme it may even be doubted whether any dust can be regarded as harmless. It is rational at least to suppose that the lung cannot become a physiological dust trap and yet retain its elasticity. It seems possible that any dust, no matter how innocuous in small concentrations, would in large enough quantity eventually overwhelm the defences of the lung and accumulate in such amounts as to impair function; such a form of lung disease would be the result of causes of a mechanical nature-the physical presence of large amounts of inert foreign material. The term "benign pneumoconiosis " has been given to this type of disease in order to contrast it with diseases resulting http://thorax.bmj.com/ from the inhalation of siliceous matter. But besides this group of conditions occupational dust may give rise to inflammatory lesions, allergic responses, and neoplastic changes. INFLAMMATORY CHANGES Inflammatory changes may be caused by inorganic metals, such as manganese, on September 24, 2021 by guest. Protected copyright. beryllium, vanadium, and osmium, giving.rise to a chemical pneumonitis; and by organic matter, such as decaying hay and grain, bagasse, cotton fibre, and similar substances where the aetiology is somewhat obscure, though fungi are frequently blamed. -
Cephalosporins Can Be Prescribed Safely for Penicillin-Allergic Patients ▲
JFP_0206_AE_Pichichero.Final 1/23/06 1:26 PM Page 106 APPLIED EVIDENCE New research findings that are changing clinical practice Michael E. Pichichero, MD University of Rochester Cephalosporins can be Medical Center, Rochester, NY prescribed safely for penicillin-allergic patients Practice recommendations an allergic reaction to cephalosporins, ■ The widely quoted cross-allergy risk compared with the incidence of a primary of 10% between penicillin and (and unrelated) cephalosporin allergy. cephalosporins is a myth (A). Most people produce IgG and IgM antibodies in response to exposure to ■ Cephalothin, cephalexin, cefadroxil, penicillin1 that may cross-react with and cefazolin confer an increased risk cephalosporin antigens.2 The presence of of allergic reaction among patients these antibodies does not predict allergic, with penicillin allergy (B). IgE cross-sensitivity to a cephalosporin. ■ Cefprozil, cefuroxime, cefpodoxime, Even penicillin skin testing is generally not ceftazidime, and ceftriaxone do not predictive of cephalosporin allergy.3 increase risk of an allergic reaction (B). Reliably predicting cross-reactivity ndoubtedly you have patients who A comprehensive review of the evidence say they are allergic to penicillin shows that the attributable risk of a cross- U but have difficulty recalling details reactive allergic reaction varies and is of the reactions they experienced. To be strongest when the chemical side chain of safe, we often label these patients as peni- the specific cephalosporin is similar to that cillin-allergic without further questioning of penicillin or amoxicillin. and withhold not only penicillins but Administration of cephalothin, cepha- cephalosporins due to concerns about lexin, cefadroxil, and cefazolin in penicillin- potential cross-reactivity and resultant IgE- allergic patients is associated with a mediated, type I reactions. -
Airbag Pneumonitis
Hindawi Publishing Corporation Case Reports in Medicine Volume 2010, Article ID 498569, 2 pages doi:10.1155/2010/498569 Case Report Airbag Pneumonitis Raghav Govindarajan, Gustavo Ferrer, Laurence A. Smolley, Eduardo Araujo Oliveira, and Franck Rahaghi Department of Pulmonary Medicine, Cleveland Clinic Florida, 2950 Cleveland Clinic Boulevard, Weston, FL 33331, USA Correspondence should be addressed to Raghav Govindarajan, [email protected] Received 29 June 2010; Accepted 13 September 2010 Academic Editor: Steven A. Sahn Copyright © 2010 Raghav Govindarajan et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The widespread and mandatory use of airbags has resulted in various patterns of injuries and complications unique to their use. Airbags have been implicated in a spectrum of pulmonary conditions ranging from exacerbation of asthma, reactive airway diseases to new onset asthma. We report a case of inhalational chemical pneumonitis that developed after exposure to the airbag fumes. 1. Introduction room air. There were no significant electrolyte abnormalities. Chest X-ray PA and lateral view revealed left lower lobe and ffi The 2001 United States national highway tra csafety retocardiac infiltrate. CT chest noncontrast revealed tree in administration report estimated that airbags reduce driver bud opacities in the right middle lobe, left lingual. Ground fatality by 12%–14% [1].The widespread and mandatory glass opacity was also seen in the posterior basal segment of use of airbags has resulted in various patterns of injuries the left lower lobe (Figure 1). -
Thirty Workers in Missouri Popcorn Plant Diagnosed With
Occupational Lung SSSEEENNNSSSOOORRR Disease Bulletin Massachusetts Department of Public Health Occupational Health Surveillance Program, 250 Washington Street, 6th Floor, Boston, MA 02108 Tel: (617) 624-5632 Fax: (617) 624-5696 www.mass.gov/dph/ohsp June 2006 Dear Health Care Provider, An investigation of the workplace revealed that diacetyl, Welcome to the June issue of the SENSOR an artificial butter flavoring ingredient, was linked with the Occupational Lung Disease Bulletin! In this issue, we employees’ symptoms. Animal studies conducted by focus on the topic of bronchiolitis obliterans, a severe lung flavoring manufacturers as early as 1993 showed that disease that can occur in workers that make or handle inhalation of diacetyl resulted in severe lung injury. food flavoring. Bronchiolitis obliterans has been linked to Additional studies completed in 2002 confirmed these diacetyl, an artificial butter flavoring ingredient. The findings1. The National Institute for Occupational Safety illness has been called “popcorn lung disease” because of and Health (NIOSH) issued an alert in 2004, warning of the clusters of workers in popcorn plants that have been the danger posed by vapors, dusts or sprays of flavorings diagnosed with the disease. However, workers in plants and recommending controls to ensure worker safety in making food ranging from pastries and frozen food to plants using or making flavorings. NIOSH recommended nacho chips and candy may be exposed to the chemicals substituting less hazardous flavoring ingredients as the in food flavorings, and therefore may be at risk for best option for controlling health risks to workers. bronchiolitis obliterans. In addition, workers who use Additional options include local exhaust ventilation or, if diacetyl to produce artificial flavorings are also at risk. -
Occupational Lung Disease Bulletin
Occupational Lung Disease Bulletin Massachusetts Department of Public Health Winter 2017 The objective of the IARC is to identify hazards that are Dear Healthcare Provider, capable of increasing the incidence or severity of malignant neoplasms. The IARC classifications are not Dr. Neil Jenkins co-wrote this Occupational Lung Disease based on the probability that a carcinogen will cause a Bulletin, during his rotation at MDPH from Harvard School cancer or the dose-response, but rather indicate the of Public Health. He brought expertise in welding from a strength of the evidence that an agent can possibly cause materials science and occupational medicine background, a cancer. as well as involvement in welding oversight with the The IARC classifies the strength of the current evidence American Welding Society. that an agent is a carcinogen as: Remember to report cases of suspected work-related lung Group 1 Carcinogenic to humans disease to us by mail, fax (617) 624-5696 or phone (617) Group 2A Probably carcinogenic to humans 624-5632. The confidential reporting form is available on Group 2B Possibly carcinogenic to humans our website at www.mass.gov/dph/ohsp. Group 3 Not classifiable as to carcinogenicity To receive your Bulletin by e-mail, to provide comments, Group 4 Probably not carcinogenic to humans or to contribute an article to the Bulletin, contact us at [email protected] In 1989, welding fume was classified as Group 2B Elise Pechter MPH, CIH because of "limited evidence in humans" and "inadequate evidence in experimental animals." Since that time, an additional 20 case-control studies and nearly 30 cohort studies have provided evidence of increased risk of lung Welding—impact on occupational health cancer from welding fume exposure, even after Neil Jenkins and Elise Pechter accounting for asbestos and tobacco exposures.3 Studies of experimental animals provide added limited evidence 3 Welding joins metals together into a single piece by for lung carcinogenicity. -
Vs. Long-Course Antibiotic Treatment for Acute Streptococcal Pharyngitis: Systematic Review and Meta-Analysis of Randomized Controlled Trials
antibiotics Review Short- vs. Long-Course Antibiotic Treatment for Acute Streptococcal Pharyngitis: Systematic Review and Meta-Analysis of Randomized Controlled Trials Anna Engell Holm * , Carl Llor, Lars Bjerrum and Gloria Cordoba Research Unit for General Practice and Section of General Practice, Department of Public Health, Øster Farimagsgade 5, 1014 Copenhagen, Denmark; [email protected] (C.L.); [email protected] (L.B.); [email protected] (G.C.) * Correspondence: [email protected]; Tel.: +45-261-110-54 Received: 9 September 2020; Accepted: 21 October 2020; Published: 26 October 2020 Abstract: BACKGROUND: To evaluate the effectiveness of short courses of antibiotic therapy for patients with acute streptococcal pharyngitis. METHODS: Randomized controlled trials comparing short-course antibiotic therapy ( 5 days) with long-course antibiotic therapy ( 7 days) for patients with ≤ ≥ streptococcal pharyngitis were included. Two primary outcomes: early clinical cure and early bacterial eradication. RESULTS: Fifty randomized clinical trials were included. Overall, short-course antibiotic treatment was as effective as long-course antibiotic treatment for early clinical cure (odds ratio (OR) 0.85; 95% confidence interval (CI) 0.79 to 1.15). Subgroup analysis showed that short-course penicillin was less effective for early clinical cure (OR 0.43; 95% CI, 0.23 to 0.82) and bacteriological eradication (OR 0.34; 95% CI, 0.19 to 0.61) in comparison to long-course penicillin. Short-course macrolides were equally effective, compared to long-course penicillin. Finally, short-course cephalosporin was more effective for early clinical cure (OR 1.48; 95% CI, 1.11 to 1.96) and early microbiological cure (OR 1.60; 95% CI, 1.13 to 2.27) in comparison to long-course penicillin. -
Updates in Antibiotic Therapy for Common Illnesses
UPDATES IN ANTIBIOTIC THERAPY FOR COMMON ILLNESSES AMY BROOKS, PHARMD, BCPS CLINICAL PHARMACIST CONCORD HOSPITAL CONCORD, NH DISCLOSURES I HAVE NO FINANCIAL RELATIONSHIPS TO DISCLOSE I WILL BE DISCUSSING DOSING AND INDICATIONS OF ANTIBIOTICS THAT MAY NOT BE FDA APPROVED OBJECTIVES • Explain basic pharmacology of major antibiotic drug classes • Develop an understanding of why certain antibiotics are used for certain disease states • Discuss first-line antibiotic choices for common disease states • Discuss circumstances in which alternative antibiotics would be necessary BACKGROUND • Studies have shown that up to 50% of all antibiotics prescribed are inappropriate.1 • Leads to increased morbidity, mortality, cost, and bacterial resistance1 • The spread of resistant bacteria can affect patients who were not even exposed to the antibiotics.2 • The CDC estimates that more than 2 million people are infected with antibiotic resistant bacteria yearly, leading to approximately 23,000 deaths each year. 2 BACKGROUND • 262.5 million antibiotics prescribed in the outpatient setting each year3 • Outpatient prescribing practices affect local resistance patterns3 • Prescribing practices vary by state and season3 • Azithromycin and amoxicillin are the most commonly prescribed outpatient antibiotics3 ANTIBIOTIC DRUG CLASSES • Penicillins • Cephalosporins • Carbapenems • Fluoroquinolones • Macrolides • Clindamycin • Glycopeptides (vancomycin) • Daptomycin • Linezolid BASIC ANTIBIOTIC PRINCIPLES • Dose matters (pharmacokinetics) • The location of the infection -
Community-Acquired Pneumonia ©Adam Spivak/Ambulatory Curriculum 2014
Community-Acquired Pneumonia ©Adam Spivak/Ambulatory Curriculum 2014 Section 1: Diagnostic criteria of community-acquired pneumonia (CAP) Radiographic finding of new infiltrate plus at least two of: fever; cough; chest pain; dyspnea. To qualify as "community- acquired", patient should not o have been hospitalized in an acute care hospital for >2D in past 90 days o be a nursing home or long-care facility resident o received intravenous antibiotic therapy/chemo/wound care in past 30 days o attended a hospital or hemodialysis clinic. Section 2: Most common etiologic agents of CAP Streptococcus pneumoniae Haemophilus pneumoniae Mycoplasma pneumoniae Chlamydophila pneumoniae Staphylococcus aureus Moraxella catarrhalis Section 3: Common pathogens in specific clinical scenarios Alcoholism Streptococcus pneumoniae and anaerobes COPD / smoking S. pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Legionella Nursing Home residency S. pneumoniae, gram-negative bacilli, H. influenzae, Staphylococcus aureus, anaerobes, and Chlamydophila pneumoniae Poor dental hygiene Anaerobes HIV infection (early stage) S. pneumoniae, H. influenzae, and Mycobacterium tuberculosis HIV infection (late stage) Above plus P. jiroveci, Cryptococcus, and Histoplasma species Travel to southwestern US Coccidioides species Influenza active in community Influenza, S. pneumoniae, S. aureus, S. pyogenes, and H. influenzae Suspected large volume aspiration Anaerobes (chemical pneumonitis, obstruction) Structural disease of lung Pseudomonas aeruginosa, Burkholderia (Pseudomonas) cepacia, S. aureus Injection drug use S. aureus, anaerobes, M. tuberculosis, and S. pneumoniae Airway obstruction Anaerobes, S. pneumoniae, H. influenzae, and S. aureus Section 4: Risk stratification in CAP management Step 1: If none of below present, outpatient mgmt. Step 2: Use if any positives in Step 1. Admit if score>70 ok Predictors of increased risk 1 pt. -
A Review of Recommended Antibiotic Therapies with Impact on Outcomes in Acute Otitis Media and Acute Bacterial Sinusitis
REPORTS A Review of Recommended Antibiotic Therapies With Impact on Outcomes in Acute Otitis Media and Acute Bacterial Sinusitis Michael E. Pichichero, MD, and Diana I. Brixner, RPh, PhD cute otitis media (AOM) and acute efficacy and adherence in the treatment of bacterial sinusitis (ABS) manage- AOM and ABS. A ment is becoming increasingly com- plex, with continual changes in the Direct and Indirect Costs pathogens responsible for these conditions. of AOM and ABS Treatment involves the selection of an effi- The total costs of both AOM and ABS can cacious agent displaying a favorable adher- be high. Direct AOM and ABS costs are typ- ence profile. Although antibiotic efficacy is ically based on medication use and physi- critical to treatment successes, therapy cian visits. Annual estimates of direct AOM adherence is arguably of equal importance, costs range from $1.96 billion to $4.1 bil- because failure to adhere to even the most lion,2,3 whereas direct sinusitis costs (as a effective therapy can ultimately lead to clin- primary diagnosis) are estimated at $1.8 bil- ical failure and undermine treatment efforts. lion.4 However, direct costs represent only a The dual importance of efficacy and adher- portion of the total economic burden of ill- ence requires additional consideration when ness. Indirect costs can include the expense treating pediatric infections. Managed care of care for sick children, transportation organizations (MCOs) are increasingly costs, the value of work time lost, baby-sit- aware that a balance is needed when weigh- ting fees, ancillary medication costs, and ing efficacy and adherence issues with expenditures for treatment of adverse antibiotics. -
Antimicrobial Use and Resistance (AUR) Module
February 2021 Antimicrobial Use and Resistance (AUR) Module Contents Antimicrobial Use and Resistance (AUR) Module ................................................................................. 1 Introduction .................................................................................................................................................. 1 1. Antimicrobial Use (AU) Option ................................................................................................................. 2 Introduction ......................................................................................................................................... 2 Requirements ....................................................................................................................................... 3 Data Analyses ....................................................................................................................................... 8 References .......................................................................................................................................... 14 Appendix A. Table of Instructions: Antimicrobial Use Option ........................................................... 15 Appendix B. List of Antimicrobials...................................................................................................... 17 Appendix C. Example Calculations of Antimicrobial Days .................................................................. 21 Appendix D: List of SAARsa ................................................................................................................