Adverse Events Associated with Fosfomycin Use: Review of the Literature and Analyses of the FDA Adverse Event Reporting System Database.

Infect Dis Ther. 2015 Dec;4(4):433-58.

Iarikov D1, Wassel R2, Farley J2, Nambiar S2.

Author information

1US Food and Drug Administration, Silver Spring, MD, USA. Dmitri.Iarikov@fda.hhs.gov

2US Food and Drug Administration, Silver Spring, MD, USA.

Abstract

INTRODUCTION:

The growing problem of antibacterial resistance resulted in an increased interest in fosfomycin, especially its parenteral formulation. We reviewed fosfomycin safety profile using the Food and Drug Administration Adverse Event (AE) Reporting System (FAERS) and published literature.

METHODS:

We conducted a FAERS search and disproportionality analysis of all fosfomycin-associated AEs. We also conducted a FAERS search for AEs implicating fosfomycin as the primary suspect and a search of reports of fosfomycin-associated bone marrow toxicity. We then review the literature for publications reporting AEs associated with fosfomycin by conducting PubMed searches.

RESULTS:

The disproportionality analysis of all FAERS reports of fosfomycin-associated AEs produced a higher than expected frequency of agranulocytosis, liver injury, severe skin reactions, and pseudomembranous colitis. Subsequent search for AEs where fosfomycin was the primary suspect and the literature review did not suggest a higher association of fosfomycin with these AEs. The search of bone marrow toxicity reports did not demonstrate an association between aplastic anemia and fosfomycin. The literature review selected 23 trials of parenteral administration of fosfomycin in 1242 patients including 8 comparative and 15 non-comparative trials. For oral fosfomycin, only prospective comparative trials (n = 28) in 2743 patients were included. The most frequent AEs associated with parenteral fosfomycin included rash, peripheral phlebitis, hypokalemia, and gastrointestinal disorders. Serious AEs such as aplastic anemia, anaphylaxis, and liver toxicities were reported infrequently. Gastrointestinal disorders were the most common AEs associated with oral fosfomycin.

CONCLUSION:

The identified AEs were consistent with the safety profile of fosfomycin. No new safety signals related to either parenteral or oral fosfomycin were identified.

PDF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4675770/pdf/40121_2015_Article_92.pdf

December 5, 2016 at 8:29 am

Vaccinations for pregnant women.

Obstet Gynecol. 2015 Jan;125(1):212-26.

Swamy GK1, Heine RP.

Author information

1Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Duke University, Durham, North Carolina.

Abstract

In the United States, eradication and reduction of vaccine-preventable diseases through immunization has directly increased life expectancy by reducing mortality.

Although immunization is a public priority, vaccine coverage among adult Americans is inadequate.

The Institute of Medicine, the Community Preventive Services Task Force, and other public health entities have called for the development of innovative programs to incorporate adult vaccination into routine clinical practice.

Obstetrician-gynecologists are well suited to serve as vaccinators of women in general and more specifically pregnant women.

Pregnant women are at risk for vaccine-preventable disease-related morbidity and mortality and adverse pregnancy outcomes, including congenital anomalies, spontaneous abortion, preterm birth, and low birth weight.

In addition to providing direct maternal benefit, vaccination during pregnancy likely provides direct fetal and neonatal benefit through passive immunity (transplacental transfer of maternal vaccine-induced antibodies).

This article reviews: 1) types of vaccines; 2) vaccines specifically recommended during pregnancy and postpartum; 3) vaccines recommended during pregnancy and postpartum based on risk factors and special circumstances; 4) vaccines currently under research and development for licensure for maternal-fetal immunization; and 5) barriers to maternal immunization and available patient and health care provider resources.

PDF

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4286306/pdf/nihms639082.pdf

December 4, 2016 at 10:52 am

Primary pyomyositis. Review of 32 cases diagnosed by ultrasound.

Medicina (B Aires). 2016;76(1):10-8.

[Article in Spanish]

Méndez N1, Gancedo E, Sawicki M, Costa N, Di Rocco R.

Author information

1Sector Ecografía de la División Radiodiagnóstico, Hospital de Infecciosas Francisco J. Muñiz, Buenos Aires, Argentina. E-mail: namendez@fibertel.com.ar

Abstract

Primary pyomyositis is a bacterial infection of striated muscle which is acquired by hematogenous route. It is related to risk factors such as HIV/aids and other immuno suppressing diseases, and can be associated with local muscle stress factors.

The most frequent etiology is Staphylococcus aureus. Its diagnostic delay may cause a fatal evolution. In this series 32 patients with primary pyomyositis diagnosed by ultrasound were evaluated. The most frequent risk factor was HIV/aids (61%).

Local factors were detected in 21 (66%) cases: first, the practice of football. The monofocal form was observed in 19 (59%), the most commonly affected muscles were quadriceps, calves and psoas. Samples for bacteriological study were obtained in 30 cases, 22 blood culture and 27 abscess materials.

In 30 cases the etiologic agent was isolated. Staphylococcus aureus accounted for 83.3% (25 cases) and Escherichia coli, Nocardia spp., Streptococcus agalactiae, nontuberculous mycobacteria, Pseudomonas aeruginosa were isolated in one case each.

Seventeen patients received surgical treatment, aspirative punctures, 9; antibiotics alone, 4. Twenty eight (93.3%) patients had a good evolution; deaths, 2 (6.6%); unknown, 2.

Main conclusions of this study were: due to the diverse and changing etiology of the primary pyomyositis it is important to recognize the etiological agent involved and their antibiotic susceptibility.

The ultrasound performed the study in real time so it can be used to guide the puncture and to facilitate the immediate diagnosis. This makes the difference with other techniques and transforms it into a first-line method for the study of this disease.

PDF

http://www.medicinabuenosaires.com/PMID/26826987.pdf

December 3, 2016 at 4:57 pm

2016 BHIVA GUIDELINES for the routine investigation and monitoring of Adult HIV-1-positive individuals 72 pags

British HIV Association

Writing Group: Brian Angus (Chair), Gary    Brook (Vice-chair), Funmi Awosusi, Gary Barker, Marta Boffito, Satyajit Das, Lucy Dorrell, Esther Dixon-Williams, Charlotte Hall, Bridie Howe, Sebastian Kalwij, Nashaba Matin, Eleni Nastouli, Frank Post, Melinda Tenant-Flowers, Erasmus Smit, Dan Wheals

NHS Evidence has accredited the process used by the British HIV Association (BHIVA) to produce guidelines.

Accreditation is valid for five years from July 2012 and is applicable to guidance produced using the processes described in the British HIV Association (BHIVA) Guideline Development Manual. More information on accreditation can be viewed at www.nice.org.uk/accreditation

PDF

http://www.bhiva.org/documents/Guidelines/Monitoring/2016-BHIVA-Monitoring-Guidelines.pdf

December 3, 2016 at 9:35 am

2016 BHIVA GUIDELINES for the treatment of HIV-1-positive Adults with antiretroviral therapy

The British HIV Association

Writing Group

Laura Waters (Chair)

N Ahmed, B Angus, M Boffito, M Bower, D Churchill, D Dunn, S Edwards, C Emerson, S Fidler, †M Fisher, R Horne, S Khoo, C Leen, N Mackie, N Marshall, F Monteiro, M Nelson, C Orkin, A Palfreeman, S Pett, A Phillips, F Post, A Pozniak, I Reeves, C Sabin, R Trevelion, J Walsh, E Wilkins, I Williams, A Winston

†Professor Martin Fisher died in April 2015 – he made a significant contribution to these, many other guidelines and our speciality as a whole – he is greatly missed.

Introduction

The overall purpose of these guidelines is to provide guidance on best clinical practice in the treatment and management of adults with HIV infection on antiretroviral therapy (ART).

The scope includes: (i) guidance on the initiation of ART in those previously naïve to therapy; (ii) support of people living with HIV (PLWH) on treatment; (iii) management of individuals experiencing virological failure; and (iv) recommendations in specific populations where other factors need to be taken into consideration.

The guidelines are aimed at clinical professionals directly involved with and responsible for the care of adults with HIV infection, and at community advocates responsible for promoting the best interests and care of HIV-positive adults. They should be read in conjunction with other published BHIVA guidelines.

The 2016 interim update to the 2015 BHIVA antiretroviral guidelines has been published online to include tenofovir-alafenamide/emtricitabine as a preferred NRTI backbone for first-line therapy. Changes were based on new data and the consensus opinion of the writing committee. All changes to the guideline are highlighted and include updates to the chronic kidney disease and bone disease sections of special populations and some small changes to managing virological failure. The next formal update to the guidelines in anticipated in 2017.

PDF

http://www.bhiva.org/documents/Guidelines/Treatment/2016/treatment-guidelines-2016-interim-update.pdf

December 3, 2016 at 9:33 am

2015 UK National GUIDELINE for the Use of HIV PEP Following Sexual Exposure

The British HIV Association

Introduction

We present the updated British Association for Sexual Health and HIV (BASHH) guidelines which aim to provide evidence-based recommendations for the most appropriate use of HIV post-exposure prophylaxis following sexual exposure (PEPSE).

The aim of PEPSE is to prevent HIV transmission. Risk of transmission, timing of PEP, preferred regimen, drug-drug interactions, follow-up, risk reduction and special scenarios are discussed. Consideration is given to the role of PEPSE within the broader context of HIV prevention and sexual health.

The guideline is intended to be complementary to existing Department of Health and Expert Advisory Group on AIDS (EAGA) guidance on PEP (1).

It is aimed primarily at clinicians and policymakers in sexual health, sexual assault referral centres (SARCs), and primary and emergency care providers within the UK who should consider the development of appropriate local pathways.

It is likely that this guideline will also be used for information provision by voluntary sector agencies to provide information for individuals.

The recommendations are aimed primarily at individuals aged 16 or older and may not be appropriate for use in all situations, including occupational exposures.

Decisions to follow these recommendations must be based on the professional judgment of the clinician and consideration of individual patient circumstances and available resources.

PDF

https://www.bashh.org/documents/PEPSE%202015%20guideline%20final_NICE.pdf

December 3, 2016 at 9:31 am

2015 BHIVA GUIDELINES on the use of vaccines in HIV-positive Adults

Writing Group

Chair and Editor: Prof Anna Maria Geretti

Members (in alphabetic order):

Dr Gary Brook, Central Middlesex Hospital, London

Ms Claire Cameron, Public Health England, London

Dr David Chadwick, James Cook University Hospital, Middlesbrough

Prof Neil French, University of Liverpool

Prof Robert Heyderman, University College London

Dr Antonia Ho, University of Liverpool

Dr Michael Hunter, Belfast Health and Social Care Trust

Dr Shamez Ladhani, Public Health England, London

Dr Mark Lawton, Royal Liverpool University Hospital

Dr Eithne MacMahon, Guy’s & St Thomas’ NHS Foundation Trust & King’s College London, London

Dr John McSorley, Central Middlesex Hospital, London

Dr Anton Pozniak, Chelsea and Westminster Hospital, London

Dr Alison Rodger, University College London

Introduction

These guidelines provide updated, GRADE-based recommendations on the use of vaccines in HIV-positive adults. Several factors have made the updating of HIV-specific vaccination guidelines important: effective antiretroviral therapy (ART) has substantially modified the natural history of HIV infection, vaccination practices are evolving, and a large number of novel vaccines are becoming available in clinical care.

The update contains important new guidance regarding the use of new vaccines against human papillomavirus (HPV), shingles (herpes zoster) and pneumococcus. Further key updates are related to the use of hepatitis B, meningococcus and pertussis vaccines.

Compared with HIV-negative individuals, HIV-positive adults often have an increased risk of infection or experience more severe morbidity following exposure to vaccine-preventable diseases, and therefore a lower threshold for extending indications and offering vaccination may be appropriate relative to the general population.

Improved health and prognosis mean that HIV-positive adults are also increasingly likely to engage in travel or occupations that carry a risk of exposure to infectious agents, and these otherwise healthy individuals should not be denied protection or engagement with such activities if evidence indicates vaccination is safe and immunogenic.

Immune responses to vaccination are often sub-optimal in HIV-positive patients, and while these improve with ART, they often remain lower and decline more rapidly than in HIV-negative individuals.

However, many of these vaccines still afford protection and for some vaccines it is possible to improve immunogenicity by offering modified vaccine schedules, with higher or more frequent doses, without compromising safety.

Since their publication, these guidelines have been endorsed by the British Infection Association (BIA), European Clinical AIDS Society (EACS) and the Royal College of General Practitioners (RCGP).

PDF

http://www.bhiva.org/documents/Guidelines/Vaccination/2015-Vaccination-Guidelines.pdf

December 3, 2016 at 9:28 am

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