Safety of ProHance in special populations

Yoshikawa, Kouki; Davies, Alexandra

doi:10.1007/pl00006901

Cited by 37 publications

(28 citation statements)

References 15 publications

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“…Comparable results have been extracted from the ProHance database of phase I-III clinical trials, which included 119 pediatric patients out of a total of 2656 injections. There was no correlation between age and the adverse event rate of 6.6% for doses ranging from 0.1 to 0.3 mmol/kg (95,96). In a meta-analysis of data from seven Omniscan studies with 353 pediatric patients ranging in age from neonate to 18 years, 0.1 mmol/kg of Omniscan resulted in a 4% overall adverse event rate (97).…”

Section: Pediatricsmentioning

confidence: 95%

MR contrast agents: Physical and pharmacologic basics

Lin

Brown

2007

Magnetic Resonance Imaging

223

175

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Since approval of the first magnetic resonance (MR) contrast agent was granted in 1988, there has been remarkable growth in the utilization of intravenous gadolinium (Gd)-based agents. Currently it is estimated that nearly half of all MR studies performed are contrast-enhanced. Despite containing a toxic heavy metal, these agents have proven to be not only an effective diagnostic adjunct to non-enhanced MRI, but also remarkably well tolerated and safe. As a result, conventional wisdom has been that MR contrast media are "biologically inert," a notion that is clearly false. Ultimately, it is the radiologist's responsibility to understand the potential adverse effects of Gd-based agents and the special situations in which they are likely to occur; however, the basic pharmacology of contrast agents is generally not included in medical school curricula or formally taught in residency. The purpose of this review is to discuss the mechanism of action of MR contrast agents and relevant aspects of their clinical pharmacology, including effects on the cardiovascular and renal systems, potential laboratory errors, and special situations involving women and children. We also briefly discuss the issue of nephrogenic systemic fibrosis (NSF).

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Section: Pediatricsmentioning

confidence: 95%

MR contrast agents: Physical and pharmacologic basics

Lin

Brown

2007

Magnetic Resonance Imaging

223

175

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“…After one dialysis session, approx. 70 % of the contrast medium is eliminated, > 90 % after the second, and 98 % after the third treatment [48]. An additional important aspect is discussed by the ACR.…”

Section: European Society Of Urogenital Radiology (Esur) Guidelinesmentioning

confidence: 99%

Application of Extracellular Gadolinium-based MRI Contrast Agents and the Risk of Nephrogenic Systemic Fibrosis

Heverhagen

Krombach

Gizewski

2014

Fortschr Röntgenstr

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!Nephrogenic systemic fibrosis (NSF) is a serious, sometimes fatal disease. Findings in recent years have shown that a causal association between gadolinium containing contrast media and NSF is most likely. Therefore, the regulatory authorities have issued guidelines on the use of gadolinium-containing contrast media which have reduced the number of new cases of NSF to almost zero. However, it is for precisely this reason that the greatest care must still be taken to ensure that these guidelines are complied with. The most important factors are renal function, the quantity of gadolinium administered and coexisting diseases such as inflammation. All of these factors crucially influence the quantity of gadolinium released from the chelat in the body. This free gadolinium is thought to be the trigger for NSF. Other important factors are the stability of the gadolinium complex and furthermore the route of its elimination from the body. Partial elimination via the liver might be an additional protective mechanism. In conclusion, despite the NSF risk, contrast-enhanced MRI is a safe diagnostic procedure which can be used reliably and safely even in patients with severe renal failure, and does not necessarily have to be replaced by other methods.

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“…Second, concurrent conduction of two different RCTs, one enrolling low-risk and another enrolling high-risk patients, may also be an alternative approach. Finally, surveillance data collected by the pharmaceutical industry, the regulatory agents, researchers and clinicians A c c e p t e d M a n u s c r i p t regarding experience of the usage of newly licensed drugs in high-risk populations may also be very useful in clarifying safety issues [55][56][57].…”

Section: Discussionmentioning

confidence: 99%