Safety of gadolinium‐DTPA: Extended clinical experience

Abstract

This review reports data on the general and renal tolerance of the paramagnetic contrast agent Gd-DTPA after intravenous administration. Gd-DTPA was administered usually at a dose level of 0.1-0.2 mmol/kg body wt (range: 0.005-0.25 mmol/kg body wt) in cranial, spinal and body MR indications. In phase I-IIIa studies a total of 2154 healthy volunteers and patients were investigated, usually at a dose of 0.1 mmol/kg body wt. From the obtained results it was concluded that adverse events (AEs) may be expected in the order of magnitude of 1%. In phase IIIb-IV studies 13,439 patients were investigated at 0.1 or 0.2 mmol/kg body wt. Tolerance data were collected according to a standardized protocol and metaanalysis of obtained data was performed. AEs, irrespective of their drug relationship, were observed in 1.15% of the patients. The observed AEs were comparable to those after intravenous administration of iodinated nonionic X-ray contrast media. There was no correlation between patient age and the incidence of AEs. In patients with a known history of allergy the incidence of AEs increased to 2.6%. In pediatric use no added risk was observed in a total of 826 neonates, children, and adolescents up to 18 years of age. Gd-DTPA showed good renal tolerance in patients with and without preexisting impairment of renal function. A prospective open safety and pharmacokinetic study was conducted in patients with hemodialysis. Gd-DTPA was shown to be eliminated completely by hemodialysis. Fast bolus injections were tolerated without added risk. Presented data from postmarketing surveillance (up to March 31, 1991) cover an estimated total of more than 2,000,000 applications.(ABSTRACT TRUNCATED AT 250 WORDS)

Safety update on the possible causal relationship between gadolinium‐containing MRI agents and nephrogenic systemic fibrosis

“…None of these were classified as severe or life threatening. These findings support the conclu-sions from another study in 2154 volunteers and patients (25), concluding that a delayed excretion of gadolinium-containing chelates from the body had no adverse effects.…”

Safety of Gadopentetate Dimeglumine after 120 Million Administrations over 25 Years of Clinical Use

“…[13][14][15][16][17] In the Phase I-IV clinical trials, the overall incidence of drug-related AEs was 3.2z (Bayer, data onˆle). In the Phase I-IIIa studies, which included 2,154 healthy volunteers and patients in the EU and Japan, the incidence of drugrelated AEs was 0.6z; in the USA, the incidence was 7.6z.…”

Gadolinium-Enhanced MR Cisternography to Evaluate Dural Leaks in Intracranial Hypotension Syndrome

“…13,14 Although adverse reactions from Gd-DTPA are rare, they do include nausea, vomiting, headache, anaphylactoid reactions, and seizure. 15,16 In the past few years, solute Gd-DTPA also has been used to contrast cavities such as joints 17 and the subarachnoid space.…”