Gadavist MR contrast agent for use in children under age 2 has won FDA approval based on a newly released study, according to its maker, Bayer HealthCare. This is the first gadolinium-based contrast agent approved for use in this patient population.

It's used to detect and visualize areas with disrupted blood-brain barrier and abnormal vascularity of the central nervous system. "Until this study, there were limited data regarding the use of gadolinium-based contrast agents in pediatric patients younger than 2 years of age, and there has been a significant need to better understand how they work in our youngest patients," Dr. Ravi Bhargava, study investigator and pediatric radiologist at the University of Alberta in Canada, said in a statement.

The study involved 47 healthy pediatric patients ranging from neonates to 23 months, from nine facilities in the U.S., Canada and Europe. It found that those pediatric patients had similar pharmacokinetic and safety profiles to those of older children and adults after receiving a standard Gadavist dose of 0.1 mmol/kg.
One of the patients experienced vomiting, which was reported as a mild adverse drug reaction to Gadavist. Coughing, nasopharyngitis, rhinitis, pyrexia and vomiting were the most common non-serious adverse events reported that were unrelated to Gadavist.

In March 2011, the contrast agent was approved for intravenous use in diagnostic MR for adults and older children and in June, it received approval to evaluate the existence and stage of malignant breast disease.

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