Strategic decisions enable Bracco to
serve better the needs of healthcare providers and patients with
its enhanced pipeline offering
MONROE
TOWNSHIP, N.J., July 8, 2024
/PRNewswire/ -- Bracco Diagnostics Inc. (BDI), the U.S. subsidiary
of Bracco Imaging S.p.A., a leading global company in the
diagnostic imaging business, is pleased to provide an update on its
barium product portfolio as part of a comprehensive rationalization
process.
Bracco Diagnostics Inc. launched an initiative with its barium
portfolio to invest in new and expanded product offerings driven by
customer and patient demand. In addition, the company is pursuing
FDA approval for its fourth product and expects to file for
approval later this year. Upon anticipated approval, BDI will offer
an enhanced line of FDA-approved barium products for abdominal
imaging needs.
"We remain committed to advancing the barium and oral imaging
field," said Cosimo De Pinto, Senior
Vice President of Sales and Marketing at BDI. "Our ongoing
investment in new and expanded product offerings reflects our
dedication to supporting healthcare providers in delivering
exceptional patient care."
At the same time, market changes and evolving procedural changes
have led BDI to discontinue three of its non-FDA-approved barium
products due to a significant decline in product usage. BDI
does not anticipate discontinuing any additional barium
products.
"We understand the importance of providing high-quality
diagnostic imaging solutions to our customers," continued
Cosimo De Pinto. "Our
rationalization process was essential to ensure that our resources
are allocated effectively to meet the evolving needs of the medical
community."
As part of its commitment to innovation, BDI is excited to
unveil its pipeline, providing a glimpse of its upcoming product
launches over the next 24 months:
Q3 2024: CitraClear™, a gutsy filling beverage,
designed to enhance patient satisfaction during preparation for
imaging procedures.
Q4 2024: VARIBAR® (barium sulfate) "Mini" packaging,
offering convenient and sustainable packaging options for
healthcare facilities.
2025: Introduction of a new flavor in our CT barium line,
further enhancing the patient experience during imaging
examinations.
BDI invites healthcare providers and industry partners to
explore its barium pipeline and looks forward to continuing to
collaborate in advancing diagnostic imaging technologies.
INDICATIONS for VARIBAR® (barium sulfate)
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., Monroe Twp., NJ 08831.
VARIBAR is a registered trademark of E-Z-EM, Inc.
For additional information about Bracco's products, and for
full prescribing information, please visit
http://imaging.bracco.com/us-en.
About Bracco Imaging
Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco
Group, is an innovative world leader delivering end-to-end products
and solutions through its comprehensive portfolio across diagnostic
imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve
people's lives by shaping the future of prevention and precision
diagnostic imaging. The Bracco Imaging portfolio includes products
and solutions for all key diagnostic imaging modalities: X-ray
imaging, magnetic resonance imaging (MRI), Contrast Enhanced
Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers
and novel PET imaging agents. Bracco Imaging has approximately
3,600 employees and operates in more than 100 markets globally.
Bracco Imaging has a well-skilled and innovative Research and
Development (R&D) organization with an efficient
process-oriented approach and track record in the diagnostic
imaging industry. R&D activities are located in four centers
based in Italy, Switzerland, the United Kingdom,
and the United States. Bracco
Group global revenues were 1.4 billion Euros in 2020. To
learn more about Bracco Imaging,
Bracco Diagnostics Inc. Media Relations (USA)
Kimberly Gerweck
Senior Manager,
Marketing
Communications
BDIMediaContact@diag.bracco.com
D:
+1 609-524-2777
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SOURCE Bracco Group