The French-based company Guerbet have
announced that, after the FDA approval earlier this year of the company’s
gadolinium-based contrast agent, Dotarem, the first injections of the product
in the United States have now taken place. The Cincinnati Children’s Hospital
Medical Center (Cincinnati Children’s) carried out the injection of Dotarem which is the only macrocyclic and ionic
gadolinium-based contrast agent (GBCA) approved by the US Food and Drug
Administration. The first injection procedure was performed in a school age child.
“The availability of a macrocyclic and
ionic gadolinium-based contrast agent that is FDA-approved for use in children
ages 2-18 is very desirable,” said Dr. Daniel Podberesky, head of
thoraco-abdominal imaging in the Department of Radiology, Cincinnati
Children’s. In the past year, Cincinnati
Children’s performed 18,000 total MRIs, with more than 6,600 being carried out
as contrast-enhanced MRIs. In addition to the first pediatric patient in the
Unites States, the first adult injection of Dotarem in the US took place in
the Winthrop-University Hospital in
Mineola, NY. The procedure was performed
in an adult with borderline renal function.
Dotarem is indicated for intravenous use with MRI in intracranial, spine
and associated tissues in adult and pediatric patients (2 years of age and
older) to detect and visualize areas with disruption of the blood brain barrier
(BBB) and/or abnormal vascularity.
Earlier this year Guerbet
announced that it was investing
significantly in the company’s three production sites in France with a total of
20 million Euros being invested to increase production capacity, maintain
quality assurance and improve the environmental impact of the production
plants.