To the Editor: We report two cases of severe gastrointestinal disease temporally related to ingestion of olestra-containing products.
Patient 1 is an 11-year-old girl with a 4-week history of diarrheal stools. She ate potato chips containing olestra and within hours developed flatulence and orange-colored anal discharge. She continued to ingest the chips, with progression of symptoms to lower abdominal pain and cramps and foulsmelling, oily, diarrheal bowel movements three to four times daily. Stool studies were negative. Her diarrhea improved slightly when she discontinued the chips after 14 days. However, she developed rectal bleeding and underwent colonoscopy that revealed ulcerative colitis from the transverse colon to the rectum. She was initially treated with prednisone and mesalamine and is currently doing well with mesalamine and 6-mercaptopurine.
Patient 2 is a 13-year-old boy who was examined for abdominal distension and inability to produce stool. His symptoms began within hours of consuming a few potato chips containing olestra. He developed abdominal cramping with intense back pain, explosive diarrhea, and gas. Stool studies were negative, colonoscopy revealed a dilated lumen but normal mucosa, and radiographic studies demonstrated colonic distention. After 4.5 months, a 23-pound weight loss, and marked abdominal distention, the patient underwent colectomy. The final pathologic diagnosis was probable pseudo-obstruction syndrome. The patient is currently doing well.
Olestra is a fat substitute promoted as a way to consume snack foods without increasing fat intake. At the time of approval by the Food and Drug Administration (FDA) in 1996, many experts expressed concerns about side effects and inadequate testing of long-term safety (1). As a condition of approval and based on findings of clinical trials, the FDA mandated labeling to note increased risk of abdominal cramping and loose stools, and inhibition of absorption of vitamins A, D, E, and K (2). Postapproval trials, sponsored by Procter & Gamble, concluded there was no increase in those symptoms; however, one study lacked statistical power (3), and the other did show more frequent bowel movements and increased loose stools in the subgroup with highest potato chip consumption (4).
Whether olestra triggered the conditions in these two children cannot be proven. However, these cases serve as an important reminder of the lack of available data about potentially severe, but much less frequent, effects of this product. Doctors should be aware that olestra might have other health risks than generally appreciated and should report adverse reactions to the FDA.
Drs. Barlam and McCloud did not receive any financial support for this report.
Tamar F. Barlam
*Center for Science in the Public Interest Washington, DC
†Miller's Children's Hospital Long Beach, California
1. Blackburn H. Sounding board: Olestra and the FDA. N Engl J Med
2. US Department of Health and Human Services, Food and Drug Administration. Olestra: final rule. Federal Register
3. Cheskin LJ, Miday R, Zorich N, et al. Gastrointestinal symptoms following consumption of olestra or regular triglyceride potato chips. JAMA
4. Sandler RS, Zorich NL, Filoon TG, et al. Gastrointestinal symptoms in 3181 volunteers ingesting snack foods containing olestra or triglycerides. Ann Intern Med
Editor's note: As the authors of this letter clearly state, the association between olestra and the two clinical situations reported may be no more than coincidence or may represent the response of a preexisting but unrecognized gastrointestinal condition to the stress of an unabsorbable compound. The Center for Science in the Public Interest has a longstanding and very well-publicized concern about the use of olestra in foods, and actively solicits reports of adverse reactions.