General reproduction, perinatal‐postnatal, and teratology studies of nitrofurantoin macrocrystals in rats and rabbits

Prytherch, J P; Sutton, Maurice; Denine, E P

doi:10.1080/15287398409530542

Cited by 14 publications

(10 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…at ASPET Journals on May 11, 2018 dmd.aspetjournals.org Downloaded from studies have not shown side effects of fetal exposure of this drug (Prytherch et al, 1984), and human studies with a relatively small amount of data did not show evidence of harmful effects of NFT to the fetus Ben David et al, 1995), adverse effects related to the fetal exposure of NFT have recently been suggested. For example, there is evidence that links craniosynostosis to fetal exposure to NFT and drugs with similar chemical structures (Gardner et al, 1998;Källén and Robert-Gnansia, 2005).…”

Section: Bcrp and Fetal Distribution Of Nitrofurantoinmentioning

confidence: 99%

Breast Cancer Resistance Protein 1 Limits Fetal Distribution of Nitrofurantoin in the Pregnant Mouse

Zhang¹,

Wang²,

Unadkat³

et al. 2007

Drug Metabolism and Disposition

View full text Add to dashboard Cite

ABSTRACT:The efflux transporter, the breast cancer resistance protein (BCRP), is most abundantly expressed in the apical membrane of the placental syncytiotrophoblasts, indicating that it could play an important role in protecting the fetus by limiting xenobiotic/drug penetration across the placental barrier. In the present study, we examined whether Bcrp1, the murine homolog of human BCRP, . These results clearly suggest that Bcrp1 significantly limits fetal distribution of NFT in the pregnant mouse, but has only a minor effect on the systemic clearance of the drug.

show abstract

Section: Bcrp and Fetal Distribution Of Nitrofurantoinmentioning

confidence: 99%

Breast Cancer Resistance Protein 1 Limits Fetal Distribution of Nitrofurantoin in the Pregnant Mouse

Zhang¹,

Wang²,

Unadkat³

et al. 2007

Drug Metabolism and Disposition

View full text Add to dashboard Cite

show abstract

“…Pregnant Sprague-Dawley rats were treated orally by gavage with nitrofurantoin macrocrystals in a 0.5 % aqueous methyl cellulose suspension at doses of 0 (n = 18), 10 (n = 19), 20 (n = 17) or 30 (n = 20) mg/kg b.w. per day from day 6 to 15 of pregnancy (Prytherch et al, 1984). On day 20 of pregnancy, the dams were killed and mothers and fetuses were examined.…”

Section: Embryotoxicity and Teratogenicitymentioning

confidence: 99%

“…per day from day 6 to 15 of pregnancy (Prytherch et al, 1984). On day 20 of pregnancy, the dams were killed and mothers and fetuses were examined.…”

Section: Embryotoxicity and Teratogenicitymentioning

confidence: 99%

“…per day (n = 17) or 250 mg/kg b.w. per day (n = 13) on days 9, 10 and 11 of gestation (Nomura et al, 1984 Embryotoxicity was studied in rats (Sprague-Dawley) treated with nitrofurantoin (macrocrystals) by gavage in a suspension of 0.5 % aqueous methylcellulose (Prytherch et al, 1984). Male rats were treated with vehicle and divided into three groups (n = 15) or with 10 mg/kg b.w.…”

Section: Embryotoxicity and Teratogenicitymentioning

confidence: 99%

“…Rabbits (New Zealand White) were bred-one male with several females-until pregnancy was verified (Prytherch et al, 1984). Rabbits were treated by gavage with nitrofurantoin macrocrystals in a 0.5 % aqueous methyl cellulose suspension at doses of 0 (n = 17), 10 (n = 15), 20 (n = 12) and 30 (n = 15) mg/kg b.w.…”

Section: Embryotoxicity and Teratogenicitymentioning

confidence: 99%

See 2 more Smart Citations

Scientific Opinion on nitrofurans and their metabolites in food

Panel¹

2015

EFS2

View full text Add to dashboard Cite

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...

show abstract

Exposure to Nitrofurantoin During the First Trimester of Pregnancy and the Risk for Major Malformations

Goldberg

Koren

Landau

et al. 2013

The Journal of Clinical Pharma

View full text Add to dashboard Cite

Antibacterial drugs are among the most common medications used by pregnant women. While medical literature generally defines nitrofurantoin as an antibiotic that is safe for use during the first trimester of pregnancy, new concerns about a possible association between congenital malformations following exposure to nitrofurantoin during the first trimester of pregnancy have recently surfaced. To address these concerns, we conducted a large population-based retrospective cohort study to assess this possible association (including cases of medical terminations of pregnancy or stillbirth) and congenital malformations. A computerized database for medications dispensed to pregnant women in southern Israel was linked with records from the district hospital. Associations between exposure to nitrofurantoin during the first trimester and major malformations were assessed. Our research included a total of 105,492 pregnancies, 1,112 of which involved pregnancy terminations for medical reasons. A total of 1,329 infants and abortuses had been exposed to nitrofurantoin during the first trimester of pregnancy. Exposure to nitrofurantoin was not associated with increased risk of major malformations in general (adjusted OR = 0.85, 95% CI 0.67-1.08) or with specific malformations. First trimester exposure to nitrofurantoin was not associated with increased risk for total major congenital malformations or with specific malformations.

show abstract

General reproduction, perinatal‐postnatal, and teratology studies of nitrofurantoin macrocrystals in rats and rabbits

Cited by 14 publications

References 10 publications

Breast Cancer Resistance Protein 1 Limits Fetal Distribution of Nitrofurantoin in the Pregnant Mouse

Breast Cancer Resistance Protein 1 Limits Fetal Distribution of Nitrofurantoin in the Pregnant Mouse

Scientific Opinion on nitrofurans and their metabolites in food

Exposure to Nitrofurantoin During the First Trimester of Pregnancy and the Risk for Major Malformations

Contact Info

Product

Resources

About