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The most frequently reported adverse reactions to products containing pancrelipase are gastrointestinal in nature. Less frequently, allergic-type reactions have also been observed. Extremely high doses of exogenous pancreatic enzymes have been associated with hyperuricosuria and hyperuricemia when the preparations given were pancrelipase in powdered or capsule form, or pancreatin in tablet form.

In two clinical studies with ULTRASE® MT (pancrelipase capsules) in 193 patients with cystic fibrosis, the adverse events described were all gastrointestinal in nature and may actually represent symptoms of the underlying disease, such as abdominal pain/cramps (5.7%), diarrhea (3.6%), and greasy stools and flatulence (1.5% each). In a postmarketing trial with another enteric-coated formulation, 160 adverse events occurred in the 15,711 patients (0.97%) evaluated.10 The most frequent events reported were diarrhea, skin reaction, and abdominal discomfort (0.2% each).

Colonic strictures have been reported in cystic fibrosis patients treated with both high- and lower-strength enzyme supplements.11 A causal relationship has not been established. The possibility of bowel stricture should be considered if symptoms suggestive of gastrointestinal obstruction occur. Since impaired fluid secretion may be a factor in the development of intestinal obstruction, care should be taken to maintain adequate hydration, particularly in warm weather.12

"Fibrosing colonopathy" is a term used to describe a condition seen in patients with CF who have taken high amounts of pancreatic enzyme supplements ( > 6,000 lipase U/kg/meal). At its most advanced, this condition leads to colonic strictures.

  1. In whom should one consider the diagnosis of fibrosing colonopathy?
    1. Patients with cystic fibrosis who have evidence of partial or complete obstruction, bloody diarrhea or chylous ascites.
    2. Patients who have two of the following three symptoms:
      • abdominal pain
      • ongoing diarrhea
      • poor weight gain

      ESPECIALLY if they have:

      • taken > 6,000 lipase U/kg/meal
      • age less than twelve years
      • history of meconium ileus
      • prior intestinal surgery
      • history of recurrent DIOS
      • "inflammatory bowel disease"13