The FDA-Approved
RIGHT Products for
the RIGHT Exam

The FDA-Approved
RIGHT Products for
the RIGHT Exam


All images shown are representative images from referenced studies.
Individual results may vary.

The FDA-Approved
RIGHT Products for
the RIGHT Exam

The FDA-Approved
RIGHT Products for the RIGHT Exam

The FDA-Approved
RIGHT Products for the RIGHT Exam

The FDA-Approved
RIGHT Products for the RIGHT Exam

Those who choose VARIBAR® know the power of preparation in clinical practice. This also means the power that comes with transparent information exchange for our customers.

We invite you to explore this key information and data on everything from standardization and dysphagia to white papers, videos, and links for resources.

Standardization

Evidence

Dysphagia

Experience the POWER of Standardization

VARIBAR® is the ONLY Contrast Validated for Standardized, Well-Tested Protocols During Modified Barium Swallow Studies (MBSS)1

Standardization Helps YOU Help Your PATIENTS

The VARIBAR line of products, with standardized viscosities, consistently addresses the most important needs in Modified Barium Swallow Studies.

The Importance of Standardization

Lack of standardized practices:

  • Impedes understanding of true results of treatment4
  • Produces ambiguous reporting of outcomes4
  • Hinders understanding of restorative and rehabilitative targets4
View a brief whiteboard animation about the importance of standardization in MBSS.

The POWER of Evidence in MBSS

Evidence, Rather than Opinion, Should Guide Clinical Decision-Making with Standardized Instruments, Data Collection Protocols, Analysis of Test Results, and Reporting.4

Developing standards for the MBSS is a key concern throughout the Speech/Language Pathology (SLP) community.1,3 VARIBAR products were developed in cooperation with SLPs to help standardize diagnostic materials for accurate comparisons between studies.

The ONLY premixed*, premeasured, and precise barium preparations for MBSS that may:

  • Enable reproducible results2-5
  • Support high-quality imaging3,4
  • Reduce preparation time and wasted materials
  • Avoid undesirable coating inherent to traditional GI barium sulfate preparations2,3,5
Normaler_Schluck-00.jpg (and others): Hellerhoff derivative work: Anka Friedrich, CC BY 4.0, via Wikimedia Commons

Time-Tested and Trusted—A Legacy of Stability

Standardized viscosities help eliminate the unpredictability of varied barium preparations1-4

View a brief whiteboard animation about consistency and clinical decision making in MBSS.

Adult Patients With Dysphagia Are 1.7 Times More Likely to Die in Hospital Than Are Patients Without Dysphagia6

Dysphagia is a Substantial Health and Cost Burden on the US Healthcare System.6
Standardizing the Method of Assessment Can Help Reduce This Impact.4

One in 25 adults are reported to have dysphagia, or difficulty swallowing, annually:7 3.0% of adult inpatients (age 45–90) are affected by dysphagia.6

Total inpatient costs are up to 44% higher, per admission, among patients with dysphagia—equaling $4.3–$7.1 billion in additional hospital costs annually.6

Hospital length of stay was 8.8 days (for those with dysphagia) compared to 5.0 days (in the non-dysphagia group).6
Patients with dysphagia were over 3 times more likely to be transferred to a post-acute care facility.6
View a brief whiteboard animation about the economic benefits of standardization in MBSS.

INDICATIONS AND USAGE | IMPORTANT SAFETY INFORMATION

These products should not be used in patients with known or suspected perforation of the gastrointestinal (GI) tract; known obstruction of the GI tract; high risk of GI perforation such as those with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis; high risk of aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation; known severe hypersensitivity to barium sulfate or any of the excipients of the product used.

INDICATIONS AND USAGE | IMPORTANT SAFETY INFORMATION

VARIBAR® (barium sulfate)

INDICATIONS
VARIBAR® THIN HONEY (barium sulfate) oral suspension, VARIBAR® NECTAR (barium sulfate) oral suspension, and VARIBAR® THIN LIQUID (barium sulfate) oral suspension are radiographic contrast agents indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients.

VARIBAR® HONEY (barium sulfate) oral suspension and VARIBAR® PUDDING (barium sulfate) oral paste are radiographic contrast agents indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
These products should not be used in patients with known or suspected perforation of the gastrointestinal (GI) tract; known obstruction of the GI tract; high risk of GI perforation such as those with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis; high risk of aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation; known severe hypersensitivity to barium sulfate or any of the excipients of the product used.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Barium sulfate preparations contain a number of excipients, including natural and artificial flavors, and may induce serious hypersensitivity reactions. The manifestations include hypotension, bronchospasm and other respiratory impairments, and dermal reactions including rashes, urticaria, and itching. A history of bronchial asthma, atopy, food allergies, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions. Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction.

Intra-abdominal Barium Leakage
The use of VARIBAR PRODUCTS is contraindicated in patients at high risk of perforation of the GI tract. Administration of VARIBAR PRODUCTS may result in leakage of barium from the GI tract in the presence of conditions such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with a severe stenosis at any level of the GI tract, especially if it is distal to the stomach. The barium leakage has been associated with peritonitis and granuloma formation.

Delayed Gastrointestinal Transit and Obstruction
Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, on a low residue diet, taking medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration after the barium sulfate procedure. When administering VARIBAR PUDDING, consider the administration of laxatives.

Aspiration Pneumonitis
The use of VARIBAR PRODUCTS is contraindicated in patients with trachea-esophageal fistula. Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. In patients at risk for aspiration, begin the procedure with a small ingested volume of VARIBAR PRODUCTS. Monitor the patient closely for aspiration, discontinue administration of VARIBAR PRODUCTS if aspiration is suspected, and monitor for development of aspiration pneumonitis.

Systemic Embolization
Barium sulfate products may occasionally intravasate into the venous drainage of the GI tract and enter the circulation as a "barium embolus" leading to potentially fatal complications which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia and prolonged severe hypotension. Although this complication is exceedingly uncommon after oral administration of a barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate.

ADVERSE REACTIONS
The most common adverse reactions are nausea, vomiting, diarrhea, and abdominal cramping. Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. 

Please click here for full Prescribing Information for VARIBAR® THIN LIQUID (barium sulfate) oral suspension.

Please click here for full Prescribing Information for VARIBAR® THIN HONEY (barium sulfate) oral suspension.

Please click here for full Prescribing Information for VARIBAR® NECTAR (barium sulfate) oral suspension.

Please click here for full Prescribing Information for VARIBAR® HONEY (barium sulfate) oral suspension.

Please click here for full Prescribing Information for VARIBAR® PUDDING (barium sulfate) oral paste.

VARIBAR is manufactured by E-Z-EM Canada Inc., for E-Z-EM, Inc., a subsidiary of Bracco Diagnostics Inc., Princeton, NJ 08540.

VARIBAR is a registered trademark of E-Z-EM, Inc.

*VARIBAR® THIN LIQUID (barium sulfate) for oral suspension is supplied as a powder and reconstituted to a standard volume with water.
†When measured at a shear rate of 30 sec–1 at 25 degrees C.
References
  1. Hazelwood RJ, Armeson KE, Hill EG, et al. Identification of swallowing tasks from a modified barium swallow study that optimize the detection of physiological impairment. J Speech Lang Hear Res. 2017 Jul;60(7):1855-1863.
  2. Hind J, Divyak E, Zielinski J, et al. Comparison of standardized bariums with varying rheological parameters on swallowing kinematics in males. J Rehabil Res Dev. 2012;49(9):1399-1404. doi: 10.1682/jrrd.2011.09.0180.
  3. Robbins J, Nicosia M, Hind JA, et al. Defining physical properties of fluids for dysphagia evaluation and treatment. Perspectives on Swallowing and Swallowing Disorders (dysphagia). 2002 Jun;11(2):16-19.
  4. Martin-Harris, B., Humphries, K., Garand, K.L. The Modified Barium Swallow Impairment Profile (MBSImP™©) – Innovation, Dissemination and Implementation. Perspectives of the ASHA Special Interest Groups. 2017 Dec;2(4):129-138.
  5. Steele CM, Martin-Harris B, Gosa M, Allen SE. Diagnosis and Management of Swallowing Physiology: Standardized Contrast, the MBSImP™, & the IDDSI Framework. Published May 1 2021. https://appliedradiology.com/articles/diagnosis-and-management-of-swallowing-physiology-standardized-contrast-the-mbsimp-the-iddsi-framework. Accessed June 9, 2022.
  6. Patel DS, Krishnaswami S, Steger E, et al. Economic and survival burden of dysphagia among inpatients in the United States. Dis Esophagus. 2018 Jan 1;31(1):1-7. doi: 10.1093/dote/dox131.
  7. Bhattacharyya N. The prevalence of dysphagia among adults in the United States. Otolaryngol Head Neck Surg. 2014 Nov;151(5):765-9. doi: 10.1177/0194599814549156.