Barium: Pediatric drug information

Concerns related to adverse effects:

• Aspiration: Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. In patients at risk for aspiration, use with caution and begin the procedure with a small volume; some product labeling contraindicates use of oral formulations in patients at high risk of aspiration (refer to specific product labeling). Some oral formulations are not recommended in patients with a history of food aspiration. Monitor patient closely for aspiration; discontinue immediately if aspiration is suspected, and monitor for development of aspiration pneumonitis.

• Hypersensitivity: Severe hypersensitivity reactions have been reported; manifestations include hypotension, bronchospasm and other respiratory impairments, and dermal reactions including rashes, urticaria, and itching. A history of bronchial asthma, atopy (as evidenced by hay fever and eczema), food allergies, or a previous reaction to a contrast agent may increase this risk. Emergency equipment and trained personnel should be immediately available and should remain available for at least 30 to 60 minutes following administration (delayed reactions may occur).

• Intra-abdominal leakage: Administration may result in leakage of barium at any level of the GI tract in the presence of conditions that increase the risk of perforation 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. Use is contraindicated in patients at high risk of perforation of the GI tract.

• Intravasation: Barium may occasionally intravasate into the venous drainage of the large bowel 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 barium, monitor patients for potential intravasation during administration.

• Obstruction/baroliths: Oral administration of barium 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, maintain adequate hydration during and in the days following procedure and consider the administration of laxatives.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with marked hypertension or advanced cardiac disease.

Special populations:

• Debilitated patients: Use with caution in debilitated patients.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer's labeling.

• Rectal formulations: Use rectal formulations with caution when obstructive lesions of the colon are suspected; minimize the amount of barium allowed to flow proximal to obstructive lesions of the colon.

• Sodium: Some formulations may contain sodium.

• Sorbitol: Some formulations may contain sorbitol, which may cause severe reactions (eg, vomiting, hypoglycemia, jaundice, hemorrhage, hepatomegaly, hyperuricemia, kidney failure) in patients with hereditary fructose intolerance; avoid formulations containing sorbitol in patients with hereditary fructose intolerance.