FDA Approves Varibar Thin Liquid for Dysphagia Studies

The US FDA has approved barium sulfate oral suspension (Varibar® Thin Liquid; Bracco Diagnostics) indicated for use in modified barium swallow studies that detect and assess dysphagia.¹

Dysphagia, which can range from the total inability to swallow to aspiration, is associated with a number of neurologic disorders, including stroke, traumatic brain injury, dementia, cerebral palsy, multiple sclerosis, Parkinson disease, amyotrophic lateral sclerosis, Huntington disease, progressive supranuclear palsy, and myasthenia gravis. Dysphagia is also a symptom of muscular dystrophy and myotonic dystrophy, and is the primary symptom of oculopharyngeal muscular dystrophy, a severe and rare genetic disorder.

The disorder is associated with serious complications such as aspiration pneumonia, dehydration, and malnutrition. Notably, patients who experience aspiration pneumonia require hospitalization, which is associated with an in-hospital mortality rate of 10% and high healthcare costs.

"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," said Alberto Spinazzi, MD, senior vice president and chief medical and regulatory officer, Bracco Group, in a statement.¹

The latest approval makes the entire line of Varibar products the only imaging agents FDA-approved for us in modified barium swallow studies. The complete line of imaging agents includes: Varibar Thin Liquid (viscosity range <15 cps); Varibar Nectar (<150-450 cps); Varibar Thin Honey (800-1800 cps); Varibar Honey (2500-3500 cps); and Varibar Pudding (4500-7000 cps). All of the products are premixed and premeasured to help reduce preparation times and enable reproducibility across swallowing studies.

Once diagnosed, dysphagia is typically addressed by diet manipulation, namely adding thickening agents to foods. Patients may also undergo therapy that teaches them different ways to eat and chew that may help reduce the risk for aspiration. Some therapies for neurologic disorders, including botulinum toxin injections, can help improve dysphagia, while more severe cases may require gastrostomy for insertion of a feeding tube.²

Despite examination of multiple rehabilitative treatments and pharmacological agents for dysphagia, the most effective protocol for treatment has still not been identified. A recent study added additional evidence to the debate on whether pharyngeal electrical stimulation may be beneficial for patients with stroke who have a subsequent tracheotomy, but superiority of that treatment has yet to be established. Perhaps even more concerning were the findings of a recent evaluation that suggested that many patients with myasthenia gravis are not sufficiently evaluated for swallowing difficulties or their risk for aspiration by standard clinical neurologic examinations. The authors of that study proposed a combined assessment that utilizes both neurologic examination as well as swallowing studies to better characterize swallowing difficulties in these patients.

“Cooperation between board-certified otolaryngologists and neurologists is indispensable for the management [of dysphagia]” the researchers concluded.

REFERENCES

1. Bracco Diagnostics Inc. receives U.S. FDA approval for Varibar® Thin Liquid (barium sulfate) for oral suspension [news release]. Monroe Township, NJ: Bracco Diagnostics Inc. August 5, 2019. prnewswire.com/news-releases/bracco-diagnostics-inc-receives-us-fda-approval-for-varibar-thin-liquid-barium-sulfate-for-oral-suspension-300896218.html. Accessed August 6, 2019.

2. Swallowing Disorders Information Page. National Institute of Neurological Disorders and Stroke. Updated March 27, 2019. ninds.nih.gov/Disorders/All-Disorders/Swallowing-Disorders-Information-Page.