A healthy pancreas produces the enzymes lipase, protease, and amylase that assist in the cleaving of food particles and the absorption of nutrients. Patients with pancreatic insufficiency, commonly seen in the cystic fibrosis (CF) population, are unable to produce these enzymes endogenously. Standard treatment for pancreatic insufficiency is pancreatic enzyme replacement therapy administered by mouth. Most endogenous enzymes were developed prior to the Federal Food, Drug, and Cosmetic Act of 1938. As a result, they were marketed by companies and used by patients without the thorough investigation of the Food and Drug Administration (FDA). Enzyme manufacturers were given a deadline of April 28, 2010, by the FDA to conduct safety and efficacy studies and to submit New Drug Applications. Currently, there are only 3 FDA-approved enzyme products on the market: Creon, Zenpep, and Pancreaze. This article discusses the changes to pancreatic enzyme products over the past year and the challenges that CF practitioners have faced as a result of the changes.
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