Pancreatic enzyme replacement products have been used for years to improve digestion in patients with exocrine pancreatic insufficiency (EPI). These products were initially marketed before formal FDA approval was required; in 1991, however, the FDA told all manufacturers of pancreatic enzyme replacement products that they would have to submit a new drug application by April 2010 in order to keep their products on the market.
EPI is a chronic disorder characterized by a deficiency of exocrine pancreatic enzymes, which results in malabsorption, steatorrhea, and weight loss. Irreversible EPI is commonly caused by chronic pancreatitis in adults and by cystic fibrosis in children. The standard treatment for EPI is pancreatic enzyme replacement therapy (Table). Treatment with pancreatic enzyme replacement products has reduced fat malabsorption and steatorrhea.1
Pancreatic Enzyme Replacement Products. JAMA. 2017;318(19):1929. doi:10.1001/jama.2017.17384
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