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Fluoroquinolones in Children: a Review of Current Literature and Directions for Future Research

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Fluoroquinolones in Children: a Review of Current Literature and Directions for Future Research Academic Year 2015 - 2016 Fluoroquinolones in children: a review of current literature and directions for future research Laurens GOEMÉ Promotor: Prof. Dr. Johan Vande Walle Co-promotor: Dr. Kevin Meesters, Dr. Pauline De Bruyne Dissertation presented in the 2nd Master year in the programme of Master of Medicine in Medicine 1 Deze pagina is niet beschikbaar omdat ze persoonsgegevens bevat. Universiteitsbibliotheek Gent, 2021. This page is not available because it contains personal information. Ghent Universit , Librar , 2021. Table of contents Title page Permission for loan Introduction Page 4-6 Methodology Page 6-7 Results Page 7-20 1. Evaluation of found articles Page 7-12 2. Fluoroquinolone characteristics in children Page 12-20 Discussion Page 20-23 Conclusion Page 23-24 Future perspectives Page 24-25 References Page 26-27 3 1. Introduction Fluoroquinolones (FQ) are a class of antibiotics, derived from modification of quinolones, that are highly active against both Gram-positive and Gram-negative bacteria. In 1964,naladixic acid was approved by the US Food and Drug Administration (FDA) as first quinolone (1). Chemical modifications of naladixic acid resulted in the first generation of FQ. The antimicrobial spectrum of FQ is broader when compared to quinolones and the tissue penetration of FQ is significantly deeper (1). The main FQ agents are summed up in table 1. FQ owe its antimicrobial effect to inhibition of the enzymes bacterial gyrase and topoisomerase IV which have essential and distinct roles in DNA replication. The antimicrobial spectrum of FQ include Enterobacteriacae, Haemophilus spp., Moraxella catarrhalis, Neiserria spp. and Pseudomonas aeruginosa (1). And FQ usually have a weak activity against methicillin-resistant Staphylococcus aureus (MRSA). Newer compounds of FQ have higher activity against anaerobes than older compounds (2,3). FQ are rapidly absorbed in the gut after oral administration . They usually penetrate deep into the tissues and diffuse easily in intracellular spaces as concentrations in lung, bile and urine can exceed serum concentration (1). FQ concentrations in saliva, bone and cerebral spinal fluid (CSF) is usually lower than plasma. Nevertheless, the concentration of FQ in CSF is often sufficient for the treatment of meningitis (4,5). FQ are typically excreted unmetabolized in urine or via the bile where some enterohepatic circulation is possible. Oral administration of FQ generally results in high bioavailability (80- 90%), with norfloxacin being an exception as its bioavailability is significantly less (10-30%) (1,4–6). As for safety, there are a number of adverse effects associated with FQ use. two patients reported arthralgia, about 8 years after the introduction of FQ, during treatment with nalidixic acid. This led to studies in beagle dogs with nalidixic, oxolinic and pipemedic acid that showed changes in immature cartilage of weight-bearing joints. This finding prompted the FDA to issue a class label warning for FQ use in children and caused pediatric clinical trials in children to halt. The latter has made FQ administration to children controversial until today, as is reflected in the limited number of labeled pediatric FQ indications (24,25). 4 Table 1 shows the main FQ agents per generation First Generation cinoxacin nalidixic oxolinic acid piromidic acid pipemidic acid rosoxacin Second Generation ciprofloxacin enoxacin fleroxacin lomefloxacin nadifloxacin norfloxacin ofloxacin pefloxacin rufloxacin Third Generation* balofloxacin levofloxacin pazufloxacin sparfloxacin tosufloxacin Fourth Generation** clinafloxacin gemifloxacin moxifloxacin sitafloxacin prulifloxacin * Also active against Streptococci **Act at DNA gyrase and topoisomerase IV. This dual action slows development of resistance The only FDA-labeled pediatric indications for ciprofloxacin are complicated urinary tract infection (UTI) and post exposure to anthrax (25). The European Medicines Agency (EMA) labels FQ in children for complicated UTI, post-antrax expose and for broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa and for ´severe infections in children and adolescents when this is considered to be necessary, as initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.´ (24). 5 Bacterial resistance to FQ is a rapidly growing problem. During the last years, resistance to FQ has remained very high among MRSA, Pseudomonas aeruginosa and anaerobes. More worrisome are recent reports of an overall increase in FQ resistance among bacteria causing community-acquired infections, such as E. coli and Neiserria gonorrhea (3). FQ resistance rates are probably due to incorrect prescription practices and the absence of specific pediatric drug studies (2). Despite the limited number of labeled pediatric indications for FQ prescription, FQ are regularly prescribed to children (15). In this review I will summarize currently available literature regarding indications, pharmacokinetics, safety and antimicrobial resistance of FQ in children. I will review arthropathy in more depth in discussing adverse effects since this specific adverse effect is considered most drastic. I will give recommendations for clinical use and future research as well. 2. Methodology To review available literature of FQ metabolism, safety and antimicrobial resistance in children, I searched through PubMed and Google Schoolar using the following queries: ‘FQ arthropathy’,‘quinolone arthropathy in children’,‘FQ pharmacokinetics’ , ‘FQ pharmacokinetics in children’ ,‘FQ resistance’. To further understand the traditional fears for cartilage tissue damage during FQ treatment in children, I searched for studies conducted on juvenile animals as well using the query ‘FQ in juvenile animals’ on both PubMed and Google Scholar. In selecting articles for inclusion in this thesis, I included review articles published after 1980 and written in either English or Dutch for articles regarding indications and pharmacokinetics. In summarizing available literature I will focus rather on systemic use than topical use. All articles were first screened on their titles and secondly on their abstract. This allowed for an effective selection of potential studies. Hereafter, the full text was judged and only after this step I finally concluded whether or not an article should be included in my thesis. Articles were judged based on their level of evidence (GRADE), including as many review articles as possible. I will review results of my search in the following section in a qualitative way. As a literature study imposes certain difficulties in the acquisition and selection of articles it is worth noting that studies listed on Embase are not included as they have not received a peer 6 review before being published. This means that several potentially valuable articles have not been included in this study. This also applies to studies that have not (yet) been published and studies that were missed due to the limitations faced when using variable search terms. These search terms may mismatch with the keywords used to classify studies in databases such as PubMed. However, a valiant effort has been made to minimize the impact of the latter on the in- and exclusion of articles in this study. 3. Results 3.1 Evaluation of found articles 3.1.1 Analysis of search results A total of 21 articles were selected through various searches on PubMed and Google Scholar. Articles were selected based on overall relevance, date of publication, language, study type (cohort, case-control, cross-sectional or experimental designs) , and journal of publication. The query ‘FQ in children’ on PubMed returned 1702 results, among those, 1 suggested study (7) which assessed 740 patients with febrile neutropenia treated with ciprofloxacin and reports excellent treatment outcomes with high rates of success and no cases of mortality among patients. The same query also returned a more recent article (8) that monitored which FQ was used to treat certain infections. Ciprofloxacin was prescribed for 382 patients (96% of FQ prescriptions). Febrile neutropenia was by far the most common indication for FQ use. Other common indications include complicated IBD (inflammatory bowel disease), septicemia and UTI. The query ‘FQ in juvenile animals’ lead to the inclusion of three articles (9–11). Selection was also based on which type of animal species was examined, aiming to include a variety of animal species in order to further understand the reasoning behind the current doses for children. The query ‘FQ arthropathy’ resulted in 328 articles. One article (12) was included, hypothezising pathogenetic mechanisms for FQ-induced arthropathy, while also providing data of these lesions in immature rats. Later another article (13) was found using the query ‘quinolone arthropathy in children’ on PubMed after finding no relevant articles with the same query on Google Scholar. The authors of this article (13) performed a literature search 7 on FQ arthropathy in animals versus children and concluded quinolone arthropathy is to date not convincingly correlated with use of these compounds in children and adolescents. The query ‘FQ pharmacokinetics’ resulted in 3895 articles and the query ‘FQ pharmacokinetics in children’ 105. Most articles were discarded due to irrelevant patient group or deemed out of date. Three articles (4,6,14) were included. Article (4) evaluated one specific compound (ciprofloxacin-based ear drops,
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