Ineffectiveness and adverse events of nitrofurantoin in women with urinary tract infection and renal impairment in primary care

Geerts, A.; Eppenga, Willemijn L.; Heerdink, Eibert R.; Derijks, Hieronymus J.; Wensing, Michel; Egberts, Toine C. G.; Smet, Peter A. G. M. De

doi:10.1007/s00228-013-1520-x

Cited by 47 publications

(40 citation statements)

References 12 publications

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“…9,10 Also, in patients in the current study who had relatively low estimated glomerular filtration rate, nitrofurantoin was not associated with a significantly higher risk of treatment failure than was trimethoprim-sulfamethoxazole, consistent with the findings of Geerts and associates. 10 Furthermore, we found that ciprofloxacin and norfloxacin were associated with a lower rate of treatment failure than nitrofurantoin in patients with both lower and higher estimated glomerular filtration rate. These results may be explained by drug pharmacokinetics and bacterial resistance patterns.…”

Section: Discussionsupporting

confidence: 88%

“…This was a large population-based study that addressed certain limitations of previous research, including inadequate control for confounders and small sample sizes; for example, in our study, the sample of patients with reduced estimated glomerular filtration rate who received nitrofurantoin was nearly 20 times the size of a corresponding sample in a prior study. 10 The use of Ontario's health care databases and definition of a patient population with universal prescription drug coverage yielded a representative sample of older women for whom the antibiotics of interest had been prescribed. This allowed us to estimate risks with good precision and excellent external validity.…”

Section: Discussionmentioning

confidence: 99%

“…5,6 A recent review suggested that the drug be avoided only for those with estimated glomerular filtration rate below 40 mL/min per 1.73 m 2 . 8 Two recent retrospective studies suggested that the effectiveness of nitrofurantoin is no different between those with and those without reduced kidney function; 9,10 however, both studies included a limited number of patients with estimated glomerular filtration rate below 40 mL/min per 1.73 m 2 . In routine care, nitrofurantoin is frequently prescribed for patients with low estimated glomerular filtration rate, but the safety and effectiveness of this practice remain uncertain.…”

mentioning

confidence: 99%

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Kidney function and the use of nitrofurantoin to treat urinary tract infections in older women

Singh

Gandhi

McArthur

et al. 2015

CMAJ

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Kidney function and the use of nitrofurantoin to treat urinary tract infections in older women

Singh

Gandhi

McArthur

et al. 2015

CMAJ

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“…In the Netherlands, a study was undertaken to establish if women treated with nitrofurantoin for urinary tract infections and renal impairment were at a higher risk of ineffectiveness of treatment and/or serious adverse effects than women without renal impairment (Geerts et al, 2013). A cohort of 21 317 women treated with nitrofurantoin and a cohort of 7 926 women treated with trimethoprim were included in the study.…”

Section: Epidemiological Data On Nitrofuransmentioning

confidence: 99%

Scientific Opinion on nitrofurans and their metabolites in food

Panel¹

2015

EFS2

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Nitrofurans are antimicrobial agents not authorised for use in food-producing animals in the European Union. Nitrofurans are rapidly metabolised, occurring in animal tissues as protein-bound metabolites. The European Commission requested EFSA to provide a scientific opinion on the risks to human health related to the presence of nitrofurans in food and whether a reference point for action (RPA) of 1.0 µg/kg for the marker metabolites is adequate to protect public health. Data on occurrence of nitrofuran marker metabolites in food were extracted from the national residue monitoring plan results and from the Rapid Alert System for Food and Feed (RASFF). The CONTAM Panel concluded that these data were too limited to carry out a reliable human dietary exposure assessment. Instead, human dietary exposure was calculated for a scenario in which a single nitrofuran marker metabolite is present at 1.0 µg/kg in foods of animal origin, excluding milk and dairy products. The mean chronic dietary exposure for this worst-case scenario would range from 3.3 to 8.0 and 1.9 to 4.3 ng/kg b.w. per day for toddlers and adults, respectively. Nitrofurans and their marker metabolites, generally, are genotoxic and carcinogenic and, also, have non-neoplastic effects in animals. Margins of exposure (MOEs) were calculated at 2.0 × 10 5 or greater for carcinogenicity and at 2.5 × 10 3 or greater for non-neoplastic effects. The CONTAM Panel concluded that it is unlikely that exposure to food contaminated with nitrofuran marker metabolites at or below 1.0 µg/kg is a health concern. A scenario in which foods are considered to be contaminated with semicarbazide, from use of carrageenan as a food additive, at 1 µg/kg was used to assess whether it is appropriate to apply the RPA to foods of non-animal origin; MOEs of greater than 10 4 calculated for nonneoplastic effects do not indicate a health concern.© European Food Safety Authority, 2015 However, the opinion also identified certain categories of non-allowed pharmacologically active substances that are considered to be outside the scope of the procedure, including substances that are high potency carcinogens, such as nitrofurans. As nitrofurans are excluded from that opinion, and taking into account that the presence of SEM in food may be from sources other than use of nitrofurazone, the European Commission (EC) requested the European Food Safety Authority (EFSA) for a scientific opinion on the risks to human health related to the presence of nitrofurans and their metabolites in food. The opinion should include (a) an evaluation of the toxicity of nitrofurans and their metabolites for humans, considering all relevant toxicological endpoints and identification of the toxicological relevance of nitrofurans and their metabolites present in food, and (b) an exposure assessment of the EU population to nitrofurans and their metabolites from food, including the consumption patterns of specific (vulnerable) groups of the population. In addition, the opinion should assess the appropriateness of...

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“…One of the two papers cited by the MHRA as evidence supporting the change was a retrospective cohort study that analysed the records of 21,317 women treated with nitrofurantoin for a UTI 3. Renal function status was available for 3,888 women.…”

Section: Mhra Changes Nitrofurantoin Contraindication Advicementioning

confidence: 99%

DTB Select: 12 | December 2014

2014

DTB

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Every month, DTB scans sources of information on treatments, disease management and other healthcare topics for key items to bring to our readers' attention and help them keep up to date. To do this, we produce succinct, contextualised summaries of the information concerned. We also include comments on, for example, the strengths of the information,whether it contains anomalies, ambiguities, apparent error or omissions, or whether or how it affects current practice.

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Ineffectiveness and adverse events of nitrofurantoin in women with urinary tract infection and renal impairment in primary care

Cited by 47 publications

References 12 publications

Kidney function and the use of nitrofurantoin to treat urinary tract infections in older women

Kidney function and the use of nitrofurantoin to treat urinary tract infections in older women

Scientific Opinion on nitrofurans and their metabolites in food

DTB Select: 12 | December 2014

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