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.
1US Food and Drug Administration, Silver Spring, MD, USA. Dmitri.Iarikov@fda.hhs.gov
2US Food and Drug Administration, Silver Spring, MD, USA.
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.
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.
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.
The identified AEs were consistent with the safety profile of fosfomycin. No new safety signals related to either parenteral or oral fosfomycin were identified.
Obstet Gynecol. 2015 Jan;125(1):212-26.
Swamy GK1, Heine RP.
1Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Duke University, Durham, North Carolina.
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.
Medicina (B Aires). 2016;76(1):10-8.
[Article in Spanish]
Méndez N1, Gancedo E, Sawicki M, Costa N, Di Rocco R.
1Sector Ecografía de la División Radiodiagnóstico, Hospital de Infecciosas Francisco J. Muñiz, Buenos Aires, Argentina. E-mail: firstname.lastname@example.org
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.