FDA Approves Bracco’s Varibar Thin Liquid for Use in Imaging Tests for Dysphagia
The U.S. Food and Drug Administration (FDA) has approved Bracco Diagnostics’ oral suspension of barium sulfate, called Varibar Thin Liquid, for use as imaging agent to detect swallowing disorders known as dysphagia, a problem common among multiple sclerosis (MS) patients.
In the U.S., 1 in 25 adults are estimated to experience dysphagia, or difficulty swallowing, particularly with age. Dysphagia varies in severity and can be caused by a number of conditions, including MS, Parkinson’s disease, stroke, during the treatment of head and neck cancer, or because of trauma.
“The FDA approval of Varibar Thin Liquid (barium sulfate) for oral suspension represents an important event for patients who suffer from dysphagia, and require a modified barium swallow study to determine their best management,” Alberto Spinazzi, MD, Bracco’s senior vice president and chief medical and regulatory officer, said in a press release.
Lasting and temporary dysphagia frequently occurs in people with MS. Actually, these patients can experience swallowing problems very early in their disease course, before the typical symptoms of MS are evident. Dysphagia can lead to severe complications, such as malnutrition, dehydration, choking, and aspiration pneumonia, which could exacerbate other MS-related symptoms.
A standard exam for dysphagia is the modified barium swallow study (MBS), or a videofluoroscopic swallowing study, performed by a speech language pathologist and a radiologist. During this imaging procedure, the patient swallows preparations of food and liquids of various thicknesses that are mixed with barium sulfate (a contrast agent), while X-ray images are taken during swallowing.
MBS helps doctors to identify and determine the severity of swallowing problems, with items consumed progressing from small to large volumes of thin liquids, and thin to thicker viscosities.
Bracco’s Varibar is a unique line of premixed and premeasured oral suspension contrast agents approved for use in MBS studies. Previously, a variety of liquid, nectar, honey, and pudding formulations were used.
“FDA has now granted approval to the entire line of the Varibar imaging agents. This means that all Varibar products meet the safety, efficacy and quality standards of the FDA. We are proud of the fact that Varibar products are the only imaging agents approved for use in MBS studies,” Spinazzi said. “This line of ready-to-use imaging agents has a fixed concentration of barium sulfate, and standardized and premeasured viscosities, to guarantee reproducibility and accurate comparisons between initial and follow-up studies.”