Neurotoxicological consequence of long-term exposure to lanthanum

Feng, Liuxing; Xiao, Hansong; He, Xiao; Li, Zijie; Li, Fuliang; Liu, Nianqing; Zhao, Yuliang; Huang, Yuying; Zhang, Zhi Yong; Chai, Zhifang

doi:10.1016/j.toxlet.2006.02.003

Cited by 142 publications

(75 citation statements)

References 27 publications

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“…However, a prospective study on rare clinical outcomes is impracticable since very large sample sizes are needed and are, furthermore, unethical. Previous animal studies evaluating side effects of lanthanum carbonate, which is a rare metal of the same lanthanide family as gadolinium, have related this agent to reduced learning behaviour in rats at lower concentrations than now found in humans for gadolinium [22]. However, no direct neurotoxicity endpoints were evaluated [23], and adverse effects on learning behaviour in both humans and animals have not yet been described for gadolinium.…”

Section: Methodological Limitations Of Current Studiesmentioning

confidence: 99%

Gadolinium retention after administration of contrast agents based on linear chelators and the recommendations of the European Medicines Agency

2017

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The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) earlier this year recommended to suspend some marketing authorisations for Gadolinium Containing Contrast Agents (GCCAs) based on linear chelators due to the potential risk of gadolinium retention in the human body. These recommendations have recently been re-evaluated by EMA's Committee for Medicinal Products for Human Use (CHMP), and confirmed the final opinion of the European Medicines Agency. This editorial provides an overview of the available GCCAs and summarises the recent evidence of gadolinium retention. Moreover, a critical appraisal of the strengths and limitations of the scientific evidence currently available on gadolinium retention is given. Key points • EMA recommended suspension of some EU marketing authorisations of four linear GCCAs. • Brain MRI findings indicating gadolinium retention have been confirmed by mass spectrometry.• Current scientific evidence for gadolinium retention has several methodological limitations.• No clear clinical evidence exists indicating that gadolinium retention causes neurotoxicity.• Long-term safety of GCCAs, however, remains unclear.

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Section: Methodological Limitations Of Current Studiesmentioning

confidence: 99%

Gadolinium retention after administration of contrast agents based on linear chelators and the recommendations of the European Medicines Agency

2017

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“…In the literature there is a study evaluating the neurotoxicologic effect of long-term exposure to lanthanum (used to treat chronic renal failure)-one of the transition metals with properties similar to gadolinium. 65 Despite oral as opposed to intravenous administration, long-term exposure to lanthanum was shown to cause in rats a decline in neurobehavioral performance.…”

Section: Accumulation In the Brain (And Specifically The Dentate Nuclmentioning

confidence: 99%

Safety of the Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging, Focusing in Part on Their Accumulation in the Brain and Especially the Dentate Nucleus

Runge

2016

Investigative Radiology

134

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The established class of intravenous contrast media for magnetic resonance imaging is the gadolinium chelates, more generally referred to as the gadolinium-based contrast agents (GBCAs). These can be differentiated on the basis of stability in vivo, with safety and tolerability of the GBCAs dependent upon chemical and biologic inertness. This review discusses first the background in terms of development of these agents and safety discussions therein, and second their relative stability based both on in vitro studies and clinical observations before and including the advent of nephrogenic systemic fibrosis. This sets the stage for the subsequent focus of the review, the current knowledge regarding accumulation of gadolinium in the brain and specifically the dentate nucleus after intravenous administration of the GBCAs and differentiation among agents on this basis. The information available to date, from the initial conception of these agents in 1981 to the latest reports concerning safety, demonstrates a significant difference between the macrocyclic and linear chelates. The review concludes with a discussion of the predictable future, which includes, importantly, a reassessment of the use of the linear GBCAs or a subset thereof.

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“…Sevelamer has to be taken in large quantities to achieve adequate efficacy and has several gastrointestinal adverse drug reactions (ADRs) such as constipation and bloating [10]. Concerns remain regarding the potential long-term systemic effects of absorbed lanthanum from lanthanum carbonate [11,12]. There remains an unmet need for safe and effective phosphate binders.…”

Section: Introductionmentioning

confidence: 99%

JTT-751 for Treatment of Patients with Hyperphosphatemia on Peritoneal Dialysis

et al. 2014

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Background/Aims: JTT-751 (ferric citrate hydrate) is a novel iron-based phosphate approved in Japan for the treatment of hyperphosphatemia in dialysis and nondialysis patients with chronic kidney disease. Methods: In this phase 3, multicenter, open-label, dose-adjusted study, we investigated the efficacy and safety of JTT-751 in peritoneal dialysis patients. A total of 56 patients with serum phosphate ≥5.6 and <10.0 mg/dl were enrolled in the study. The dose of JTT-751 was adjusted to between 1.5 and 6.0 g/day, according to the target range of serum phosphate (3.5-5.5 mg/dl), for 12 weeks. The primary endpoint was change in serum phosphate from baseline to end of treatment. Secondary endpoints included the percentage of patients achieving target serum phosphate levels and changes in intact parathyroid hormone. Results: Serum phosphate was significantly reduced by 2.26 mg/dl (p < 0.001). The percentage of patients achieving target serum phosphate levels was 76.8%. Intact parathyroid hormone decreased significantly (p < 0.001). The most common adverse drug reactions were diarrhea and constipation. Most of the events were considered to be mild. Treatment with JTT-751 resulted in significant increases in serum ferritin and transferrin saturation (p < 0.001). Conclusion: In peritoneal dialysis patients with hyperphosphatemia, 12-week treatment with JTT-751 resulted in significant reductions in serum phosphate while simultaneously increasing serum iron parameters. JTT-751 was well tolerated.

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Neurotoxicological consequence of long-term exposure to lanthanum

Cited by 142 publications

References 27 publications

Gadolinium retention after administration of contrast agents based on linear chelators and the recommendations of the European Medicines Agency

Gadolinium retention after administration of contrast agents based on linear chelators and the recommendations of the European Medicines Agency

Safety of the Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging, Focusing in Part on Their Accumulation in the Brain and Especially the Dentate Nucleus

JTT-751 for Treatment of Patients with Hyperphosphatemia on Peritoneal Dialysis

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