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Barium Sulfate No Longer Unapproved Drug Product

Cheryl A. Thompson

BETHESDA, MD 14 Jan 2016—FDA on Monday approved the marketing of E-Z-HD barium sulfate for oral suspension for use in patients 12 years of age or older to visualize the gastrointestinal (GI) tract during double-contrast radiographic examinations of the esophagus, stomach, and duodenum.

Although barium sulfate suspension has been part of radiographic procedures for decades, E-Z-HD is the only barium-containing product in FDA's database of approved drug products.

E-Z-HD entered the U.S. market as a product marketed by E-Z-EM Inc. Bracco Diagnostics Inc. acquired E-Z-EM in 2008.

The FDA-approved labeling (PDF)External Link for E-Z-HD lists more contraindications than the unapproved labeling did.

E-Z-HD is contraindicated in patients with known or suspected perforation of the GI tract, known obstruction of the GI tract, conditions associated with a high risk of aspiration or GI-tract perforation, or known hypersensitivity to anything in the product.

The unapproved labeling had advised cautious use of the product in patients whose GI tract was completely or nearly completely obstructed.

And unlike the unapproved labeling, the FDA-approved labeling does not provide instructions on using an antihistamine, epinephrine, or aminophylline to treat allergic reactions to E-Z-HD.

The instructions for preparation of the suspension remain the same as before: add 65 mL of water to the bottle of E-Z-HD powder, secure the lid, and shake well.

However, the FDA-approved labeling recommends a dose "closer to 65 mL" for an examination of the esophagus and a dose "up to 135 mL" for an examination of the entire upper GI tract.

 

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