High-Lipase Enzymes Withdrawn

Darlene Batchelder

Spring 1994

CFRI has learned that pharmaceutical companies are withdrawing from the market pancreatic enzymes with lipase units exceeding 20,000. According to the FDA, the companies have notified CF Center physicians throughout the U.S. In some areas, the pharmacies are no longer able to provide the enzymes.

The withdrawal was prompted by reports, published in the January 8th edition of Lancet, of intestinal strictures (collapse of the intestinal wall) in patients using the high-lipase enzymes. While the high-lipase enzymes are not known to be the cause of the strictures, the drug companies must now conduct efficacy and safety studies on the products, which could take one to two years. These studies were apparently never done because the pancreatic enzymes were previously covered under less stringent over-the-counter regulations.

If this withdrawal affects you, contact your physician immediately for a prescription for lower lipase enzymes. Many high-lipase enzyme users may have a difficult time adjusting to less effective, low-lipase enzymes and we are deeply concerned that this will affect nutrition and overall health. To voice your concerns, you may write your enzyme manufacturer about this product withdrawal and you may send a copy to the Food and Drug Administration as follows:

U.S. FDA
Center for Drug Evaluation and Research
HFD-008
5600 Fishers Lane
Rockville, MD 20857
MPN-RM 151

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